June 17, 2025 • 48 mins
EB McLindon shares his extensive experience in clinical research, discussing his journey from finance and technology to building clinical trial sites. He explains the various models of research sites, the role of a CEO in a research site network, and the dynamics of competition and collaboration among sites. Our discussion covers the importance of patient recruitment, the challenges faced by sites, and the potential for technology to enhance communication and efficiency in clinical trials.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
SPEAKER_02 (00:00):
Even if you just sit in the waiting room for 30
minutes, you'd be surprised atwhat you hear and what
transacts.
But I do think everyone's talkedfor years about patient voice
and site voice.
I think that's the site voice.
The site voice isn't hearingthem complain about a tech or
complain about a delivery orlack of delivery.
It's actually going to theclinic and understanding what
(00:21):
they have to go through on agiven day because stuff changes.
SPEAKER_00 (00:36):
So who is EB?
And what do you do in clinicalresearch?
SPEAKER_02 (00:39):
I'm a bit of an enigma because of my initials,
but the research story startedfor me about 20 years ago.
Prior to that, I've been infinance and technology.
After the last 20 years, I'vebeen building clinical trial
sites.
So I started off with a companythat I helped found called
Accelavance and was thererunning that for about 10 years
and on the operations side, andthen moved into Icon and helped
(01:01):
build what's currently calledAccelaCare over there.
And then a couple of years agoin the second half of 2022, we
started And I think I've alwaysbeen enamored for some reason
with patients and doctors andbuilding clinical trial sites
has been something of a passionfor mine, certainly over the
last 20 years.
SPEAKER_00 (01:19):
You spent a long time in your career and you said
a long time, not me.
I'm repeating it.
Starting with research sites,then you go to tech, then you're
in the CRO, then you're back toresearch sites.
SPEAKER_02 (01:31):
Why the round trip?
I started off in technologyresearch.
and and spent years there didn'thave as much gray hair back then
and and then when i got intoresearch like a lot of people
you don't know how you get theresuddenly you wake up and you're
in research and it was prettycool and then if you think about
Now, 20 years ago, the tech thenversus the tech now is
(01:52):
substantially different.
So I think my early careerhelped me understand enough to
be dangerous about how to usetechnology to be more efficient
and effective.
And then the round trip withinthat last 20 years has mostly
been the passion for patientsand doctors.
That's where the data is made.
And when you're down at thatlevel, you just get a much
(02:12):
different level of appreciationfor what patients go through and
how physicians support research.
on a day-to-day
SPEAKER_00 (02:18):
basis.
So you're a CEO of a researchsite network.
I think a lot of people knowwhat a CEO does, but actually I
think there's still a lot ofconfusion and hopefully we can
unpack that for people today onwhat a research site is, what a
network is, what are thedifferent sort of iterations of
that.
But how do you describe your jobas a CEO at a research site
network?
SPEAKER_02 (02:39):
Yeah, I'd say it's glamorous, but it really isn't.
It's really the last, I mean, tobe honest with you, today I'm
doing the same things I wasdoing 10 years ago, which is
fun.
I I mean, really, you're doing alot of different things.
You're wearing a lot of hats.
It's probably no different thanthe day you have where you can
start off with an internal callabout sales and then have
external calls with sponsors andCROs.
(03:02):
And then you're right back intoan internal call trying to solve
some sort of problem.
So it's, again, the glamour init is getting to the finish
line, whether it's at a studybasis level or a project basis
level.
And any given day, it's a littlebit about problem solving.
It's a lot about strategy.
And it's really a lot abouttrying to figure out how to grow
in a market that's been verychallenging.
(03:24):
So both growing your brand whileat the same time you're trying
to grow your network.
SPEAKER_00 (03:28):
I do know there's probably a lot of listeners we
have that understand what aresearch site is.
They've been working in clinicalresearch, but maybe they don't
know all the differentvariations of a research site,
right?
All the different options thatare actually available.
So can you just do a quickexplainer?
What are the various researchsite models that are available
in today's clinical research?
SPEAKER_02 (03:47):
Yeah, so I think...
I think if you went out andwhether you Google it or go to
ChatGPT, you're going to getabout somewhere around 10 to 12
different types of clinicaltrial sites.
And some of them have beenaround for years and just
tweaked their models here andthere.
But you get everything from thephysician-owned independent
clinic, which a lot of peopleare familiar with, where a
physician has a practice in aspecialty CNS or GI or something
(04:11):
like that.
And then they decide to doresearch and it's side-saddle
with their practice.
And that's a lot of the sitesout there And then you have from
there, that's when it getsinteresting.
So then you have affiliatenetworks where no one owns each
other, but they're affiliatedmaybe through branding and
business development or throughback office.
You also have site managementorganizations, which is a
(04:31):
variation of that, where theyprovide strong kind of back
office support, but then theymight also provide coordinators.
Then you start getting intonetwork models where you have
integrated researchorganizations, which tend to,
they tend mostly to focus onhealthcare systems or large
large roll-up organizations.
You also have integratedresearch, like integrated site
(04:52):
networks.
You have AROs, academic researchorganizations.
And so what ends up happening, Ithink, is a lot of people get
lost in the taxonomy of theseand they focus so much on what
you are as opposed to what youdeliver.
I actually had a situation abouta year and a half ago where our
network got disqualified from anRFP.
(05:12):
We went through the entire RFPprocess.
And when they came to us withthe outcome, they said, oh yeah,
at the end, we disqualified youbecause you're not an XYZ.
And I said, okay, what's yourdefinition of an XYZ?
And they gave it to me.
And I said, well, we do all ofthat.
And we showed you in ourproposal and our slides that we
do all that.
And they're like, oh yeah,you're right.
(05:33):
So I think people get so caughtup in that rather than what
patient are you going after?
Where does that patient gettheir healthcare?
And where are they willing to goget their healthcare?
Because a lot of patients arewilling to go to a dedicated
center, even for some sort ofchronic disease.
But it's like, where Where arethey going for that healthcare
solution?
And is there research there?
SPEAKER_00 (05:52):
If you think about like this definition of a site
evolving and changing, and Ididn't know that there were 12
versions.
And by the way, if you did putthem in chat, GPT, you and I
both know what would happen.
you'd get a reading back, lotsof em dashes and like an icon, a
rocket icon for all of them,right?
And so just for everybodylistening, before you go post on
LinkedIn, please remove therocket icon.
(06:12):
Then we just know that youdidn't write it.
So let's say you put all thosein and the next question you ask
ChatGPT is, do these sitespartner?
Do they compete?
How do they work together in themodel?
So what would the answer be?
SPEAKER_02 (06:25):
Yeah, you'd get a little bit of both, right?
First off, I think there are alot of different definitions
only for differentiation.
A lot of people are trying tokind of strike out they don't
they don't want to be called onething so they they define
themselves as something elsewhich is which is great i mean
again some of that's market uhdriven i also think when you
look at partnering or some sortof affiliation things like that
(06:47):
i think it was easier it was Itwas competitive, but probably
friendly competition pre-COVID.
Not to bring up the PC wordalready, but in pre-COVID times,
networks, we would go toconferences and I can openly
share an opportunity because Iknew that if you were the CEO of
(07:07):
another network, I knew whereyour sites were and I knew you
weren't...
It's okay.
You're not going to take any ofmy...
of that larger scale phase two,phase three study.
Now there's so many networks outthere and they're brought back
by private equity.
So they're popping up sites.
They're acquiring some of theseindependent groups.
They're sewing them all togetherin a platform.
(07:27):
And suddenly you look around andyou even Google yourself and
you're like, well, they're likefive or 10 sites right near the
clinic.
I thought it was so special.
And so you suddenly become alittle bit more protective
because when you're backed byprivate equity, you have to hit
numbers.
And so you're trying to beprotective of that.
I think where a lot morecollaboration happens, and
(07:48):
there's some groups that arereally good at this, like SCRS
is the best example, I think,where you get a group like that
and it's a lot of learning.
It's like, how do you help othergroups learn how to negotiate a
budget and things like that?
So I think the collaborationmight be more functional and
operational and less dealtrading like we used to do, but
(08:08):
I still think the sitecommunity...
is probably the best communityfor sharing.
People want people to besuccessful for the most part.
SPEAKER_00 (08:18):
One of the things I've heard from people, right or
wrong, and so I think I need youto debunk this or just back it
up, is that when you add sitenetworks and some of these new
network models to studies,you're actually decreasing the
number of sites on a studyoverall, meaning you put a
network in, and so if I wasgoing to select 20 investigators
in the U.S.
or 20 in Europe, I'm now goingto select 10 because the site
(08:41):
network is going to take theplace of the other 10.
On the average, is that true?
Is that just what people thinkhappens competitively?
SPEAKER_02 (08:48):
Well, I think, so it's true.
And as a matter of fact, it'sfunny because I hear some folks
say, pitching that today and itwas something we were doing at
Excelevance and So I mean,again, it's like the hula hoop,
here we are.
But I will tell you, John, it'strue.
And I think it's also indicationspecific.
So you're not seeing that inoncology and rare.
(09:09):
You're seeing it certainly ingen med, certainly in vaccines
where you need less studies fromthe population, where you can
actually get a multiplier offsome of these larger dedicated
clinics.
Absolutely.
I also think that there areinside larger TAs and indication
less studies level, like a CNSas an example, where there's
(09:30):
some CNS studies where you can'treally leverage it like that.
But there are other indicationswithin CNS where, yes, you can
get a little bit of a factor offof some of these network sites
so that you don't have to pullin as many.
And they're certainly sellingit.
They're selling it as a valueadd.
And I think for the most part,and this is the part that might
(09:53):
be a little mythological, isthat they're They're also giving
a discount, right?
So if a network comes in andsays, look, I've got 20 sites
that can knock the cover off theball, I'll give you an X percent
discount if you take all 20 ofthem.
I think there's some of thathappening also.
And again, there's value in thatfor the pharma sponsor.
SPEAKER_00 (10:12):
So when you talk about knocking cover off ball,
for those of you who don't know,that's a baseball term.
go Giants.
And if you think about what thatlooks like, what is that for a
high performing research site?
Like what is knocking the coveroff the ball?
And here, let me tell you my twocents.
My two cents is it's always beenabout recruitment.
It's always been aboutrecruitment, right?
Does the site have the rightpatients for this protocol and
(10:34):
do they feel like this is whatthey do all the time and they
can recruit these patients andtake care of them through a
study?
But now it's interesting.
I was with a friend who alsomanages the site and the
terminology he was using soundedso similar to what I use when I
talk about like contrasting froma technology firm to a
technology firm, right?
Where we, you know, not featureto feature, but like We as a
(10:57):
technology company do this andthis is why we're different.
What are those things besidesrecruitment?
What are the things that aredifferentiating or contrasting a
site from another site?
So they're winning the work andsomeone else isn't.
SPEAKER_02 (11:08):
You probably have to ask some biopharma clients that
because they're the ones thatare, they're the buyers for the
most part.
I think it comes down to acouple of things.
You know, to your point, firstand foremost, it's about
patients.
If you deliver the patients yousay you're going to deliver,
that's that repetitive processis what it is.
It's, I mean, coming back tobaseball, it's, you know, If
you're striking out all thetime, your coach is going to
(11:30):
bench you.
The biopharm is going to benchyou.
It's just not going to happen.
But I think there are a coupleother factors.
I think first off, it's speed tostart up.
So it's not just recruiting thepatients, but can you get your
study at a clinic up and runningfast so that those patients can
start accruing into the researchstudy?
I've always said, and I've saidthis for a very long time, that
(11:52):
really good sites recruitpatients, but the best sites
complete patients.
I mean, you know from the dataside, right?
Let's just say, for example,there's the phase two study
you're going to put 400 patientsin.
You know, the statisticiansalready factored how many folks
can drop out of that clinicaltrial in order to get that
complete data set.
Well, if you're a clinical trialsite and you're, you know, let's
(12:13):
just keep it simple, you'regoing to put 10 patients in, but
you only complete one of them.
You only get full data set forone of them.
You've left that sponsor highand dry on those nine other
patients.
So the focus is, again, is notjust driving recruiting, it's
engaging the right patients tomake sure that they fulfill
their obligation to study, whichwill help you fulfill yours.
So I think there's speed tostart up at the front end, which
(12:35):
a lot of the networks, theymanage that through central
solutions like reg, yourturnaround and contract
turnaround, things like that.
But then you look at theexecution, recruiting, yes, but
are you recruiting the rightpatients to get you that
complete data set?
SPEAKER_00 (12:49):
When you work in clinical research, especially on
the CRO side, a technologyvendor side, you're sort of
building Yeah.
Yeah.
(13:17):
you learn something new, right?
You see the real world and yousee the fact that some of the
things you work on don't cometogether perfectly.
And there's a lot going on,right?
And so I have a, you know, Ithink a different level of
respect for sites, especiallystudy coordinators, just knowing
what they do every day andunderstanding the complexity of
their job and how that's sort ofmoved to the next thing, moved
(13:38):
to the next thing all the time.
Let's say you're talking tosomebody who has, worked in
clinical research, but neveractually been to a site, never
actually seen a patient.
What do you recommend they do toreally understand that part of
business so they can apply thatto their thinking into their
job, regardless of where theywere in clinical trials?
SPEAKER_02 (13:56):
First off, it's a great question because I think
there are a lot of people thatcan conjure up in their mind
what a clinical trial site doeswithout ever having to being in
one.
So there are a couple of things.
One is, total side note, I sawon LinkedIn, speaking of
LinkedIn, that somebody followeda coordinator for a day and
they're like, that's the hardestjob I've ever seen.
(14:17):
So there's a lot of respect forcoordinators.
I have incredible respect foranyone at a clinic, from the
site manager all the way downand back up again, because what
they deal with in a given day,you can only imagine.
I mean, they're dealing withpeople and they're dealing with
physicians and they're trying tosow the two of those people
together.
And they're dealing with dataand monitors and technology.
and technology changing andpasswords changing.
(14:40):
So there's a lot that goes on.
At Accelivance, we actually hada site near our headquarters and
part of our orientation process.
I didn't care what role you had,but you spent a half a day in
our clinic to kind of marinatein that feel.
And you could feel kind of whatgoes on in a clinic in a half
day.
What I would tell people, if youhaven't been to a clinic, Google
your area.
I bet you there's a researchcenter you could drive to.
(15:03):
Call them up and say, look, I'mfrom this company.
I want to pop in and justobserve Even if you just sit in
the waiting room for 30 minutes,you'd be surprised at what you
hear and what transacts.
But I do think everyone's talkedfor years about patient voice
and site voice.
I think that's the site voice.
The site voice isn't hearingthem complain about a tech or
(15:25):
complain about a delivery orlack of delivery.
It's actually going to theclinic and understanding what
they have to go through on agiven day because stuff changes.
We're all human beings.
Human beings make mistakes.
know some of the mistakes aremade by the patients and the
sites there to help the patientkind of come back into the
clinic and make sure that thateverything's okay so i don't
(15:45):
have a good answer other thangoogle it and and go i think i
mean like if somebody googledone of our clinics and was like
hey look i just want to pop inand i mean obviously we'd have
them sign something but likejust come in i mean we love to
open our doors to people so thatthey they have a better
understanding for what it isthat happens inside a research
clinic for a research study.
SPEAKER_00 (16:07):
I'm pretty sure I was one of those people you made
go into one of the clinics.
I think so.
At some point.
I'm pretty sure I was, which isgood for me.
You know, I think we need to becareful.
So everybody in clinicalresearch, don't go sit in
everybody's lobbies at ourresearch site.
Yeah, don't
SPEAKER_02 (16:21):
stalk them.
Yeah,
SPEAKER_00 (16:22):
call it.
But I do, I think there'ssomething so important to that,
right?
Is that we, just like we see inpatient research, and we've
worked really hard to notbelieve we're the patient and
we're really not, and sort ofmaking decisions and not
listening and co-creating withpatients, we make a lot of
assumptions, right?
And we just assume, wow, that'show sites work.
That's what they care about.
Every time I ask thosequestions, and we ask healthcare
(16:43):
professionals, studycoordinators, those questions,
all the time, every time we do,the answers we get back are
usually different than how Ithink.
I think it's an importantreminder for us to keep that.
But listen, the flip side ofthis is you did bring it up,
this kind of terminology around,you said the word complaining.
I'm going use the word tension.
Because I do think, you know, ifyou log into LinkedIn, if you,
(17:06):
you know, sort of listen toconversations, you go to
conferences, you can heartension when it comes to
research centers, site networks,or research sites working with
different stakeholders inresearch.
And maybe that's mostly forLinkedIn clicks.
And I do kind of believe that toa certain degree.
But I also live in the realworld where tension is a part of
business.
And so I What's the tensionbetween sites and CROs, right?
(17:30):
And how do you overcome those tobe more efficient together?
How do these groups worktogether knowing they have maybe
some different businessobjectives?
But how do they make that work?
Because they've obviously beenmaking it work for quite some
time.
SPEAKER_02 (17:43):
Well, maybe they go visit sites more often.
I think, you know, so it's,look, to your point, I think,
for good or for bad, the adventof social media, I think 2012
was the tipping point.
We've talked about that beforewhere like suddenly now
everyone, everyone has akeyboard and has access to the
internet.
So I'm just going to lodge mycomplaints festivus for the rest
of us.
But I think when you lookspecifically at a clinic level,
(18:06):
I think the learning has to goboth ways.
So let me make that a little bitmore clear.
We just talked about going tovisit a clinic so you understand
that better.
I think there are a lot of sitesout there that don't understand
or don't really appreciate someof the decisions that biopharma
has to make on a day-to-daybasis.
And then the downstream to theCROs, they have to make
decisions based upon shippingcycles and IP viability, but
(18:32):
also technology and what'sworking, what's not working.
So I do think the learning cango both ways.
And I've done what I canspecifically inside Helios to
say, hey, look, we also have tounderstand that there's other
things going on know for thesponsor for the cro specific to
the tension i think it comesback to the same numbers that we
always hear which is at anygiven time well a trial running
(18:55):
at a clinic probably has 10different technologies and
there's all these passwords andthen there's a reliability that
there's an 800 number for thepatient to call but the patient
always calls the site so that'sone kind of you know fork in the
side of of the site levelbecause they're like hey look
you know I have to know thetechnology well enough to
support it and fix it at somelevel.
I mean, obviously notprogramming, things like that,
(19:16):
to make sure the patient isengaged.
I also think that there's a lotof pressure in research.
So look at the last two years.
The number of studies is lessthan it has been.
Studies are getting canceled anddelayed for various reasons
beyond a lot of people'scontrol.
And I think the pressure cookerthat transcends from the sponsor
to the CRO and then down to theclinic, and then there's that
(19:37):
pressure, right?
Look, to be brutally honest, inthe last 20 years, this always
flows downhill.
It flows downhill and the sitesare at the bottom catching it.
And so that tension, I thinksome of it is good for, for the
industry because you getinnovation.
You get things like embracingdecentralized trials.
You get things like embracingremote visits for the physicians
(20:01):
so that they can see thepatients in the clinic, but also
have video conferences.
I think you get embracing someof this new technology that way,
but it does come with headaches.
And I think the headaches areborn, or at least the sites feel
like they bear most of thatproblem, which I can understand.
It's not like, you know, CROsand sponsors wanting to hurt
(20:22):
them.
You know, it just happens.
SPEAKER_00 (20:25):
Talking about that tension too, if you take it and
let's move it over to patientrecruitment and patient
recruitment companies.
Yeah.
What's interesting is I havefriends, good friends that run
and own sites.
And I have good friends that arerun and built patient
recruitment companies.
And somebody recently said,well, you know, sites, we don't
like recruitment companies.
(20:45):
And I went, what?
When did this happen?
And so like debunk that for me.
Is that really true?
Or is there some kind of atension between the two that
sort of makes that relationshipcomplicated?
SPEAKER_02 (20:54):
I might have started this thing 20 years ago.
So the reason why I say that, Imean, honest to God.
So you have to remember, mybackground was finance and
technology.
I came into research.
And within five months, we wererunning our first multi-site
study as we were a subset ofsites on a phase two multi-dose.
(21:18):
It was a five-dose vaccineprogram.
I know it's a shocker, everyone,because I think most people just
thought vaccines started duringCOVID, but they've been going on
for a while with thosedinosaurs.
They have.
So for us, we had eight clinicson this trial.
And the trial was for...
I'll just say it was foranthrax.
I couldn't figure out why no onewas like, we weren't getting any
patients.
(21:39):
It was a central campaign.
We weren't getting any patients.
I called the CRO and I'm like,there's something wrong here.
We should be getting tons ofpatients.
We had clinics in areas thatshould see these people.
So they sent me the ad and itwas, I don't know what font
level that is, but it's like thesize of my head.
It said anthrax.
So I could imagine people, nowagain, 20 years ago, people at
(21:59):
bus stops, like just throwingthe newspaper down because
anthrax, This was in 2005.
It was four years after 9-11.
So I could imagine peoplerunning away from newspaper ads.
Long story short is that I thinkthe tension is that sites,
network sites particularly, likesites that have a central group
that does their recruiting forthem, they feel like they know
(22:19):
their city.
They know their town.
They know where they live betterthan some large...
third-party vendor who lives ina different state and doesn't
know anything about where theylive.
And to be honest with you,there's some truth to that.
We've run A-B sampling onrecruiting, and our recruiting
(22:40):
messages ring truer to ourpatient population, whether it's
in clinic, like through EHR, oroutside of clinic through social
media, better than a thirdparty.
I think some of it, theyremember, like sites will
remember that one time that thecancer patient was sent to them
that had the wrong tumor type.
They'll remember that for 15years.
(23:02):
They won't let go of it.
So I think some of it is, istrust.
You know, I think some of it is,is that is, is the models.
There are actually some reallygood recruiting companies now
where their financial models,they get paid for like screen,
like actual randomizations, asopposed to just throwing people
in a clinic.
So, Hey, we sent this clinic ahundred people.
Well, yeah, you send a hundredpeople that have no interest in
(23:24):
research or they don't evenunderstand that you reached out
to them for research, which isalso part of the disconnect.
So I think some of it has beenthe modeling.
And I think some of it also isthere's sites that do it really
well.
So now go backwards.
Earlier in our conversation, wewere talking about go to the
right site for the rightpatient.
Maybe deploy these third-partyvendor recruiting vendors to the
(23:44):
sites that need the help and noteverybody.
Don't make it aone-size-fits-all.
Make it optional for some sitesthat actually know how to
deliver patients.
And maybe that would help solvesome of this also.
SPEAKER_00 (23:56):
Yeah, it's interesting.
I think this fit-for-purpose usecase is always the understanding
we use.
And the A-B testing just stillto this day shocks me because
someone will, you know, just inmy daily work, someone will come
in and say, hey, we seeadvertisers doing it.
We say, have you asked patientsto actually review these?
And they'll say no.
And I'm like, doing?
(24:16):
Like ask patients, they'll A, B,C, D, E, F test this for you and
tell you what works in thatregion.
And I think it's, you're right.
When you're a site, you alreadyhave an inkling of what that
looks like because that's yourarea, right?
It's where you live.
SPEAKER_02 (24:28):
Your point, I think it's good for purpose.
I think one of the, one of thegreat things about research,
which is also one of thosedownfalls is that if you can, if
you can customize everysolution, you'll deliver a great
study, but it's hard tocustomize every solution where
you're trying to go, you know,multi-site, multi-studies, maybe
in the same therapeutic area youhave, you're targeting four
(24:51):
different indications like incancer.
Well, you can't do customizeddown to that level.
You'll just be spending way toomuch money.
And I think some level, some ofthese groups, the recruiting
groups, they do a very good job.
I just think that if they had alittle bit more skin in the
game, you'd find that they do areally good job for like
independent sites and maybe someof these groups that don't have
(25:12):
the central service already inhand.
SPEAKER_00 (25:14):
When you think about a site too, a research site,
regardless of if it's anindividual site, a network, an
SMO, an ARO, whatever that modelis, we keep talking about
different people that areservicing.
Their job is to support the siteso that they can recruit and
take care of the patients in theclinical trial.
That's the point.
And we're talking about CROs andrecruitment companies.
(25:35):
There are lots of other vendors,lots of other companies we could
talk about.
And there's always tensionthere.
I've grown up.
In the last 10 years, seeingmore and more tension between
technology and sites.
As you try to get that balanceright, From a site's
perspective, if you could juststart a tech company and say,
I'm trying to address these gapsthat we see no matter who we're
working with in the market.
(25:55):
Give me like one to two nuggets.
What's the thing that you and I,Evie, would go build to service
that gap so that sites wouldfeel even more supported or more
enhanced by the technologiesthey use?
SPEAKER_02 (26:07):
Wow, that's a loaded question.
I think I'm going to hit twoquote-unquote simple things.
simple solution.
And again, it could just be us.
Half the time I look at it, I'mlike, maybe it's just an us
problem.
But one thing that I know fromhaving multiple Helios sites on
the same study is that we go inand we'll ask a question And if
(26:32):
site A asks it to a monitor,site B asks it to a project
manager, site C asks it to theirmonitor, we might get three
different answers.
And so I know there have beenmany attempts to try to white
glove these types of solutions.
There have been attempts tocentralize communication.
I actually think there might bea chance now with the advent of
(26:52):
AI to actually do a voiceover ofwhat those answers are.
I mean, to actually let AIdevelop kind of the FAQ for a
study.
And then it knows it so thatwhen you call in, it's giving
you a centralized standardanswer for some of these
questions, because some of themare obviously more complex and
might need a little bit of ahandholding, but there are a lot
(27:14):
of them that are just kind oflike pretty simple and it's hard
to get a common answer.
So that's, I'm trying to thinkof like new tech and maybe kind
of a, kind of a little sidething there.
So that would be one is there'sa way to get a better way to
communicate the front end goinginto the study, better questions
(27:35):
and answers that are common andanswerable.
That would be one area.
I think the other area, and thisis something we've been, and I
know you guys do it yourselves,is source is the single source
of truth.
But here you have us who like weuse, resource.
And then we have to go into anEDC system.
(27:57):
That EDC system could be off theshelf product.
It could be something thatpharma has been using for 20
years, whatever it is.
So we have to take our sourceand then align it into their
CRF.
Now we use CRF guidelines to,you know, to make sure that
there's some alignment, but likeall we've done is taking double
data entry off of paper formsthat you as a monitor used to
(28:19):
mail in to a central office.
Now it's just all it's done isdistributed that workload to a
clinic.
So we're doing double data entryin our clinic.
There's gotta be a better way todo that.
And then you add a thirdelement, right?
Because there are a lot ofclinics, especially when you
start talking about you know,harder to treat populations with
rare CNS and oncology, where youwant to get some of those data
(28:40):
points back into the medicalrecord because it might
intertwine with standard ofcare.
So now you're taking data frome-source, putting it into your
medical record and then back andthen into EDC.
And I know, again, I knowthere's some groups out there
that are working on EDC to EHRand that connection or EHR to
EDC and that connection.
But really, it's the source thatwe need to figure out a better
(29:02):
way to just use that as aunifying solution because that
is taken it's taken at the visitit's the truth of what happened
at that visit it seems to methat there's a better way to use
that as opposed to thenmulti-layers of other data entry
that all it's done has just beendistributed back to the clinics
SPEAKER_00 (29:19):
there's one or two things you know about me you
know i'm not a fan of the casereport form and frankly i've
been on the tear for years toeliminate it yeah because i'm
with you 100 i feel like sourceand direct data capture has been
around a long time and it'scoming because persistence wins
in this industry, right?
It's coming.
But do all sites, researchsites, feel the same way you do
(29:41):
around, if I were to say, hey,there's no case report form,
you're just going to directenter here, and then we're going
to get this back in your EMRthere, and you're going to have
less monitoring and oversightrequired, so we're going to get
out of your way a little bitmore.
Is that advantageous to sites,or is there a component of that
that's too far for researchsites on the average?
SPEAKER_02 (29:58):
Well, I think you just hit on something that might
be too far for a lot of sites,which is everyone's like less
monitoring makes sense but wewant monitoring i mean to be
honest with you one of thevalues of a site network is that
most if not all of them i thinklike 99% of them are going to
have some quality departmentthat are looking, they're doing
their own quality checks on databefore the monitor ever comes
(30:20):
because they want to show thatthey've got good quality data,
which is again, a value ofhaving a network.
So I think if instead of yousaying we're throwing monitoring
out, I always look at it as ifyou can remote view data and reg
as an example, then when themonitor actually does show up on
site, they have much moremeaningful interaction with the
(30:40):
physician and the site teamabout their operations?
How's the study actually going?
As opposed to, I saw fivetransposition errors in the data
or whatever.
I mean, that's like easy, basic.
But I think if you did a survey,which I would highly recommend
you do, I think a lot of siteswould be all on board for a
single point of data entry.
(31:01):
And then whatever happens,whether it's a data lake,
whatever body of water it goesto, people get what they need
out of it.
And they can evaluate.
Because to be honest with you,if you actually did that, and I
won't be confused with astatistician, but I think if
you're getting that data pumpedin real time, and real time
means different things todifferent people, but on a daily
(31:21):
basis, the statistician is goingto be able to flag what looks
weird pretty quickly.
I mean, the data scientistsshould, at a minimum, be able to
go, well, here's something weirdhere.
Let's go back to the clinic andask them that question.
But what it does for you is allof a sudden it starts letting
you look across your entirestudy and really understand
what's happening with yourpatient population.
(31:42):
And you're more in tune with therhythm of the study, I think,
faster than you are when you doyour regular data cuts.
Because you're doing data cutson, you know, here's the source
data, but you're doing data cutson something over here, you
know?
And so I think sites, look, theburden of, I'll just keep
calling it double data entrybecause that's what I see it as,
is, I mean, it's a real thing.
And I think most sites would,they would appreciate a
(32:05):
streamlined way to do that withmonitoring that site so that
they make sure that they'redoing what they should be doing.
Because you have to remember,there are a lot of independent
sites.
If you ask an independent site,not 100% of the time, but if you
ask them how they manage theirquality, they would tell you,
well, that's what the monitor isfor.
SPEAKER_00 (32:23):
Yeah, I totally get that.
Well, eliminate the CRF, reducethe monitoring, not eliminate
SPEAKER_02 (32:28):
it.
Yeah, you reduce that data, muchof the data component, and then
you look at You can look at morelike problem resolution, right?
And root cause stuff.
SPEAKER_00 (32:39):
One of the key questions that I hear often, and
I don't know if I've ever had areally good answer for it.
So I've got a CEO of a sitenetwork.
I'm just going to ask you.
Is recruitment is so much of thechallenge of getting studies up
and running, right?
So tech firms and companies likethe ones I work for, you know,
we typically get, hey, how fastcan you start up?
But the reality is we can startup as fast as we want.
We still get into recruitment.
(33:00):
You get the FPI rolling andrecruitment is still your
biggest driver.
of delaying in clinical trials.
And we all know all the metricsabout how expensive that is, how
much time that is, how mucheffort it is.
We know that.
What's the thing that couldchange that could help us
recruit faster?
Is there something that needs tohappen or something that hasn't
been happening in the last 30years that someone hasn't done
yet that could really help sitesbe free and give them more
(33:24):
autonomy, give them moresupport, give them more funding,
whatever that is that would helpthem recruit patients faster so
that this research could be donemaybe six months quicker?
SPEAKER_02 (33:33):
Well, John, if I had figured that out, I'd be retired
right now.
So I think...
you know, let's take a stepback, right?
I remember 2008, the focus ofDIA that year was patient
centricity, 2008.
So here we are, 17 years later,we have more websites, we have
(33:54):
more recruiting companies, wehave more people talking about
research, but the samepercentage of physicians and the
same percentage of patientsparticipate.
Now, to be honest with you, Ithought a pivot point was COVID.
Because I don't know about you,but finally, after being in the
industry at that point for over15 years, my family finally
(34:17):
understood what I did for aliving.
But it was on the news all thetime.
And you could go to arestaurant.
People would talk about pivotalphase three studies.
It's like, wow, you're speakingmy language.
Well, then, unfortunately,obviously, a lot of things have
happened since then that havekind of sour people or dampen
some of that enthusiasm.
(34:38):
But I think there's still amoment of education.
I think that's what a lot of thegroundwork that these site
networks do very well is theybring patients in for
biospecimen studies, a simpleblood draw or a flu shot.
Hey, look, you get your flu shotover here, try a research study.
You bring things in forsomething that people know
about.
And then suddenly they're like,well, that wasn't so bad.
(35:00):
I didn't feel like a guinea pig.
I didn't feel like I had an X onmy head and I was sitting in the
corner all by myself.
Like I felt like I was part ofsomething interesting.
And then when they actually havesomething where they need
research, they're not afraid.
And I think the more we do ofthat, the better we're going to
be.
And to be honest with you, Ithink the last five years of
(35:21):
these site networks spinning upwhether it's private equity
invested or self-funded becausethey got some cashflow out of
COVID.
And so they're starting to revup their engines.
I think the more that thisbecomes professionalized at a
clinic level, the moreparticipation we will get.
I think it's, you know, researchis definitely professionalized
at the biopharma level.
(35:42):
It's definitely professionalizedat the CRO level.
And I think now we're seeing theadvent of being professionalized
at the trial site level.
SPEAKER_00 (35:49):
Shifting gears a little bit to that term around
patient engagement, patientcentricity, Yeah.
(36:13):
We knew that a lot of solutionsneed to be developed thinking
about and being in the shoes ofa patient and working as opposed
to being a sponsor of CRO andworking in.
I'll admit, it happened to metoo.
It happened in my company.
We spent so much time on thepatient first that it
overshadowed the critical roleof clinical sites and how we
(36:34):
thought about them.
And so in our business, wereally focus on the patient
piece first.
Then we moved to the siteportal, another piece second.
And just because that's what wehad to do, But at the same time,
it was a pretty common story,right?
Where sites were saying, hey,listen, you're over-indexing on
the patient.
Come meet my needs.
Come help me do this.
And so tell us, EB, how do we asan industry understand be more
(36:55):
balanced in this and stillthinking about supporting the
patient experience, butsupporting and thinking about
the site and the site as theuser that is the conduit to the
patient.
How do we do a better job ofthinking that way and acting
that way?
SPEAKER_02 (37:07):
Yeah.
Again, it's not that it's aloaded question.
It's like, where do you, to yourpoint, it's like, where do you
start?
Right.
So I think there's been, A lotof progress made in engaging
with patients in protocoldevelopment, things like that,
great.
Engaging with sites, protocoldevelopment, that's great.
I think maybe what we'retripping into here is the
(37:28):
operations side, right?
Let's be honest, the CRO doesn'twant a site telling them how to
run this.
Maybe you do, but they don't.
I think for the most part,right?
And so like, what's the learningthere?
And I think if you had, even tostart with a blank piece of
paper and say, we're just gonnado 100% tech-based, research.
Like all we're going to do,we're going to engage the
(37:49):
patients directly.
We're going to put them in, youknow, to a site if we need them
or the pharmacy, if we just needa blood draw or a shot or
whatever.
I mean, like if we just went toNova with a blank piece of
paper, to be honest with you,you probably end up kind of
where we are anyway.
I think, I think you'd end upwhere we are.
I could be wrong because youstill need at some level.
(38:10):
And again, this isn'tubiquitous.
So, you know, there are a chunkof studies where you can go
decentralized.
where you can do something likethat, where you just take a
blank piece of paper and say,how do we get this patient, like
give them the Amazon experienceof research, right?
Or the Walmart experience, like,oh, it's in aisle four.
Let me go down there and look.
How do you give them that?
That hits certain indicationswithin therapeutic areas, but
(38:33):
it's really hard to do a phaseone oncology study that way,
right?
A vast majority of the studies,you still need that PI, you
still need the site.
So to your point, how do youwork with them in a better
manner?
I think in research, the sitesjust want to give good patients,
give good data.
So instead of throwingeverything at these sites and
coming up with all sorts ofnuance, why don't we just throw
(38:56):
the things that are needed?
How do you get the best qualitydata from a patient with XYZ
indication in a phase twosetting at the right site?
And those sites will tell you,here's what the patient will do,
here's what they won't do.
Here's what the doctor will do.
Here's what the doctor won't do.
And you almost have, we have keyopinion leaders.
You almost need these siteoperation key opinion leaders.
(39:20):
So close.
Coming up with new vernacular.
But you almost have to havethese site operations folks that
have been doing it for 20 yearsor more because they've lived
through the tech piece and thenthe down and then the back up
and fully decentralized themback down.
We've been doing hybrid studiesfor 15, 20 years.
So it's not new.
It's just what's the right piecefor this type of technology?
(39:40):
So I think some of it is comingup with a better shopping list
to go through and find the rightpieces to deliver that, right?
Like everything is a bit of amosaic.
And the reason why I say amosaic is that some of those
colors, they intersect.
And I think in research, we haveto look at it as what's the
(40:02):
right site combination with theright patient like what patient
are looking for what's the rightsite combination to get that
patient then overlay what thepieces are that make them
successful and to your earliercomment it's not about what you
think is going to make themsuccessful it's about what they
think is going to make themsuccessful and it might it might
be just a little bit differentit might be the same system but
(40:23):
instead of having five differentthings they're doing in it
they're only doing one or twoand that's going to get you that
better data
SPEAKER_00 (40:28):
i think i've heard it
SPEAKER_02 (40:29):
probably 150
SPEAKER_00 (40:29):
times.
And I heard it again.
It was on the phone researchsite.
It was a study coordinator at aresearch site.
And the way she said it, samething I've heard before, but I
needed to hear it again.
And so I'm going to say it outloud and you can tell me if it's
bad advice or not.
But she said, John, the tech isgreat.
The people are nice.
I don't remember what studyyou're calling about.
Could you guys just make sureyou all do a better job in
(40:51):
context?
Know that in your world, you'vegot these things and you're
like, you're doing this.
My job is context switching.
every four and a half seconds.
So I am frantic.
I've got a patient in theclinic.
I've got the doctor needs to seehim.
I get on the call and people go,hey, could you check this and
check this?
And I'm still thinking, is thisthe star study that I'm working
on?
That's where I'm at.
(41:12):
And so she said, hey, the thingthat I wish people would do is
not just all the strategy thingsand listening to us about our
opinion on the protocol and thepatients and where to get them,
which I think are all super fairpoints because they're the
experts.
But that reminder just to say,just give me the context.
Just make sure you're repeatingthat because I've got a lot of
these going on and I can'tremember them all.
(41:33):
And I think it's so many timesit's the simple stuff, right?
It's the simple things that helpus to be more thoughtful and
empathetic about I'm workingwith the site.
They've got a lot going on.
This is what it's like to be ata site, just like all the things
you mentioned.
And so if I understand that, I'mgoing to come in this
conversation very differentlyand have a soul about it and
say, hey, how can I help you?
And so I need to do help you getin, get out, get what you need,
(41:54):
but give the context.
And for me, that was reallyimpactful.
And I said it to my team becauseI needed to hear it again.
SPEAKER_02 (41:59):
Yeah, no, I think it's a fair point.
And again, it's the day and agewhere we're at, where a research
coordinator might be working ona handful of studies.
A monitor might be working onone.
So for that monitor, when theycall in, that's the most
important question that they'reasking.
But meanwhile, the person thatthey're calling just finished a
visit on a totally differentstudy, is preparing for a visit
(42:21):
on a totally different studythan that one.
And this person just happened tobe at their desk.
They picked up the phone.
And now to your point, they'rejust saying, hey, look, I'm
calling about this.
And they're like, wait a minute,my head's spinning because
that's not where I am.
Like, that's not where I amright now.
So I think it's a good point.
I think it's also hard at thesite level to be present in that
moment.
to also be there to listen.
(42:42):
And maybe that's where some ofthe tension comes from too.
SPEAKER_00 (42:44):
If I'm a person working in clinical research and
I'm interested in working in asite or a site network, right?
I'm hearing these terms.
I say, hey, I've got goodexperience or maybe I'm new and
I'm trying to get into clinicalresearch.
And I believe that learning at asite network might be the best
early stage of my career.
What do you tell them?
What advice do you give them tolook at that route?
And then second is when theysay, great, after all that EB,
(43:05):
is AI coming after my job?
What do you say to that part ofthe question?
SPEAKER_02 (43:09):
So the The first part, as a side note, I'll tell
you that the people that I'veworked with at different CROs
and different sponsors, the bestpeople have worked at a clinic
somewhere in their career,somewhere along the way.
I think it's actually a prettyvaluable part of your own
learning as you're in research.
And again, I'm a little bit...
(43:31):
Just a little.
Just a little.
But with that said, if somebodyreally wanted to get in, I would
tell you, look in your area andsee what sites are there.
You might have to be willing todo some work that you didn't
think you're going to have todo.
in order to grow into it.
Because there are some peoplethat think very highly of
(43:52):
themselves and they're in theirmid-20s and they've done
something and now they want toget into research.
They're like, well, wait aminute, I'm at this level and
now you're putting me at thatlevel.
It's like, well, yeah, but ifyou want to actually get to this
level of research, you got tostart somewhere.
So if you're going to be in aclinic, you might start as a
patient recruiter.
You might start as a datamanagement person.
You might start as a researchassistant, depending on your
(44:13):
background.
And all I can tell you is, ishang in there.
And if you get in If it were me,I would ask whatever group I'm
applying to or talking to islike, what is your training
program?
I don't need to know I'm goingto be a next level in three
months or six months.
It's like, just do you have aplan for me?
Or is it just like I just haveto gut it out?
Because one of the issues thatsites do have is once you get to
(44:35):
a certain level, there's It'srarefied air at some point,
whether it's a regional manageror even a site leader, that
might be the best you can do inthat particular group until you
actually become an executive.
And there's not as many of thoseroles available these days.
So my point is, is if you get inand you learn, then you can
start seeing these differentoptions and you start seeing
(44:57):
what else is out there inresearch and be a part of it.
And then on the AI question, Imean, I hate to be the person
who says it's not going toaffect sites as much, It's going
to affect everybody.
I mean, there's ways to be moreefficient and effective with
your own time.
I think it's going to make aneffect on sites.
When I look at what coordinatorsdo and the things that they do
(45:17):
with patients, especially in theharder to treat populations, I
think it's going to be hard toreplicate that with AI.
Mostly, I mean, you used theword empathy before.
When you're dealing with latestage cancer patients, you're
talking about people that needhandholding.
They need care.
They need to be consoled fromtime to time.
And you can't get that from AI.
You can get that from a reallygood coordinator who's been
(45:40):
through it with other patients.
And I think that's whereresearch sites separate
themselves from paper pushers.
Yes, they're delivering data,but it's coming from a human
being, not from some chartonline.
I always say that when yourandomize patients into a study,
it's a walking lab.
I know it doesn't sound great,but it's a human being.
(46:02):
It's their biology and theirchemistry that's taking over
that study.
And you have to tether thatperson into the study.
And for us, that tether is thecoordinating staff.
It's the site.
You know, a lot of our patientslove to come to the site.
They'll still do the remotestuff.
They'll still put in theirdiaries.
They'll still have a remotevisit if they need to.
But they love that interactionbecause that's where they get
(46:23):
empathy that they might not getfrom tech.
No offense,
SPEAKER_00 (46:27):
John.
Total offense.
And it should be.
It's the way the world shouldwork.
This whole world, in my opinion,right?
But it's my podcast, so I get togive all my opinions.
Thank God for that, right?
You know...
this whole world is hybrid and Ikind of don't want that to
change.
I love the intersection of techand people and we've got to get
this stuff right.
That's how we move it forward.
(46:48):
That's how we're more inclusive.
That's how we actually changethis market.
So no, I appreciate that.
I think it's really important.
SPEAKER_02 (46:54):
And I tell our team, I mean, I've been trying to
figure out ways to utilize AI atthe site level and there are
ways to do it.
I'm not going to share all thesecrets on your podcast, but my
point to them is it makes youmore efficient and effective
with your time so that you havethat time to spend with your
maybe with your peers, but alsowith the doctor and with the
patient, because that you can'treplicate.
SPEAKER_00 (47:15):
If I'm a research site and I'm maybe not tech
savvy, I'm definitelyconsidering just starting with
the basics.
And the basics are meetingminutes, notes, question and
answer.
One of the things I saw from asite, and I know somebody got
mad at me for posting this, butI said, you could use ChatGPT.
You did some research and youwant to create an ad for for
recruitment locally that wasmore fitting.
(47:37):
It was inclusive of the peoplein your community and you wanted
to go design that ad.
You knew exactly what it lookedlike.
You had the template.
You could go build it.
Things like that I think aresuper practical, really
efficient ways for sites to usethese tools, but not going too
far yet.
Let's just get the baby steps.
Start using them.
There's so many directions wecan go.
I want to stop here.
(47:57):
Let's just bookend becauseresearch sites and networks, now
they work, was...
Just so much valuableinformation.
So EB, thank you.
Thanks for taking time today.
If someone wants to connect withyou or learn more about what
you're up to, what's the bestway to reach you?
SPEAKER_02 (48:10):
I'm a fan of just giving out my cell phone number.
I've been told not to do that inthe past, but I just give it
out.
So you can call me or text me oryou can find me on LinkedIn,
just EB McClendon.
SPEAKER_00 (48:21):
And I'd encourage you, if you're looking for a
site network and just anall-around guy that knows the
space that you want to connectwith, EB is your guy.
EB, thanks for your time.
Good to see you.
UNKNOWN (48:30):
I appreciate it.
Even if you just sit in the waiting room for 30
minutes, you'd be surprised atwhat you hear and what
transacts.
But I do think everyone's talkedfor years about patient voice
and site voice.
I think that's the site voice.
The site voice isn't hearingthem complain about a tech or
complain about a delivery orlack of delivery.
It's actually going to theclinic and understanding what
(00:21):
they have to go through on agiven day because stuff changes.
SPEAKER_00 (00:36):
So who is EB?
And what do you do in clinicalresearch?
SPEAKER_02 (00:39):
I'm a bit of an enigma because of my initials,
but the research story startedfor me about 20 years ago.
Prior to that, I've been infinance and technology.
After the last 20 years, I'vebeen building clinical trial
sites.
So I started off with a companythat I helped found called
Accelavance and was thererunning that for about 10 years
and on the operations side, andthen moved into Icon and helped
(01:01):
build what's currently calledAccelaCare over there.
And then a couple of years agoin the second half of 2022, we
started And I think I've alwaysbeen enamored for some reason
with patients and doctors andbuilding clinical trial sites
has been something of a passionfor mine, certainly over the
last 20 years.
SPEAKER_00 (01:19):
You spent a long time in your career and you said
a long time, not me.
I'm repeating it.
Starting with research sites,then you go to tech, then you're
in the CRO, then you're back toresearch sites.
SPEAKER_02 (01:31):
Why the round trip?
I started off in technologyresearch.
and and spent years there didn'thave as much gray hair back then
and and then when i got intoresearch like a lot of people
you don't know how you get theresuddenly you wake up and you're
in research and it was prettycool and then if you think about
Now, 20 years ago, the tech thenversus the tech now is
(01:52):
substantially different.
So I think my early careerhelped me understand enough to
be dangerous about how to usetechnology to be more efficient
and effective.
And then the round trip withinthat last 20 years has mostly
been the passion for patientsand doctors.
That's where the data is made.
And when you're down at thatlevel, you just get a much
(02:12):
different level of appreciationfor what patients go through and
how physicians support research.
on a day-to-day
SPEAKER_00 (02:18):
basis.
So you're a CEO of a researchsite network.
I think a lot of people knowwhat a CEO does, but actually I
think there's still a lot ofconfusion and hopefully we can
unpack that for people today onwhat a research site is, what a
network is, what are thedifferent sort of iterations of
that.
But how do you describe your jobas a CEO at a research site
network?
SPEAKER_02 (02:39):
Yeah, I'd say it's glamorous, but it really isn't.
It's really the last, I mean, tobe honest with you, today I'm
doing the same things I wasdoing 10 years ago, which is
fun.
I I mean, really, you're doing alot of different things.
You're wearing a lot of hats.
It's probably no different thanthe day you have where you can
start off with an internal callabout sales and then have
external calls with sponsors andCROs.
(03:02):
And then you're right back intoan internal call trying to solve
some sort of problem.
So it's, again, the glamour init is getting to the finish
line, whether it's at a studybasis level or a project basis
level.
And any given day, it's a littlebit about problem solving.
It's a lot about strategy.
And it's really a lot abouttrying to figure out how to grow
in a market that's been verychallenging.
(03:24):
So both growing your brand whileat the same time you're trying
to grow your network.
SPEAKER_00 (03:28):
I do know there's probably a lot of listeners we
have that understand what aresearch site is.
They've been working in clinicalresearch, but maybe they don't
know all the differentvariations of a research site,
right?
All the different options thatare actually available.
So can you just do a quickexplainer?
What are the various researchsite models that are available
in today's clinical research?
SPEAKER_02 (03:47):
Yeah, so I think...
I think if you went out andwhether you Google it or go to
ChatGPT, you're going to getabout somewhere around 10 to 12
different types of clinicaltrial sites.
And some of them have beenaround for years and just
tweaked their models here andthere.
But you get everything from thephysician-owned independent
clinic, which a lot of peopleare familiar with, where a
physician has a practice in aspecialty CNS or GI or something
(04:11):
like that.
And then they decide to doresearch and it's side-saddle
with their practice.
And that's a lot of the sitesout there And then you have from
there, that's when it getsinteresting.
So then you have affiliatenetworks where no one owns each
other, but they're affiliatedmaybe through branding and
business development or throughback office.
You also have site managementorganizations, which is a
(04:31):
variation of that, where theyprovide strong kind of back
office support, but then theymight also provide coordinators.
Then you start getting intonetwork models where you have
integrated researchorganizations, which tend to,
they tend mostly to focus onhealthcare systems or large
large roll-up organizations.
You also have integratedresearch, like integrated site
(04:52):
networks.
You have AROs, academic researchorganizations.
And so what ends up happening, Ithink, is a lot of people get
lost in the taxonomy of theseand they focus so much on what
you are as opposed to what youdeliver.
I actually had a situation abouta year and a half ago where our
network got disqualified from anRFP.
(05:12):
We went through the entire RFPprocess.
And when they came to us withthe outcome, they said, oh yeah,
at the end, we disqualified youbecause you're not an XYZ.
And I said, okay, what's yourdefinition of an XYZ?
And they gave it to me.
And I said, well, we do all ofthat.
And we showed you in ourproposal and our slides that we
do all that.
And they're like, oh yeah,you're right.
(05:33):
So I think people get so caughtup in that rather than what
patient are you going after?
Where does that patient gettheir healthcare?
And where are they willing to goget their healthcare?
Because a lot of patients arewilling to go to a dedicated
center, even for some sort ofchronic disease.
But it's like, where Where arethey going for that healthcare
solution?
And is there research there?
SPEAKER_00 (05:52):
If you think about like this definition of a site
evolving and changing, and Ididn't know that there were 12
versions.
And by the way, if you did putthem in chat, GPT, you and I
both know what would happen.
you'd get a reading back, lotsof em dashes and like an icon, a
rocket icon for all of them,right?
And so just for everybodylistening, before you go post on
LinkedIn, please remove therocket icon.
(06:12):
Then we just know that youdidn't write it.
So let's say you put all thosein and the next question you ask
ChatGPT is, do these sitespartner?
Do they compete?
How do they work together in themodel?
So what would the answer be?
SPEAKER_02 (06:25):
Yeah, you'd get a little bit of both, right?
First off, I think there are alot of different definitions
only for differentiation.
A lot of people are trying tokind of strike out they don't
they don't want to be called onething so they they define
themselves as something elsewhich is which is great i mean
again some of that's market uhdriven i also think when you
look at partnering or some sortof affiliation things like that
(06:47):
i think it was easier it was Itwas competitive, but probably
friendly competition pre-COVID.
Not to bring up the PC wordalready, but in pre-COVID times,
networks, we would go toconferences and I can openly
share an opportunity because Iknew that if you were the CEO of
(07:07):
another network, I knew whereyour sites were and I knew you
weren't...
It's okay.
You're not going to take any ofmy...
of that larger scale phase two,phase three study.
Now there's so many networks outthere and they're brought back
by private equity.
So they're popping up sites.
They're acquiring some of theseindependent groups.
They're sewing them all togetherin a platform.
(07:27):
And suddenly you look around andyou even Google yourself and
you're like, well, they're likefive or 10 sites right near the
clinic.
I thought it was so special.
And so you suddenly become alittle bit more protective
because when you're backed byprivate equity, you have to hit
numbers.
And so you're trying to beprotective of that.
I think where a lot morecollaboration happens, and
(07:48):
there's some groups that arereally good at this, like SCRS
is the best example, I think,where you get a group like that
and it's a lot of learning.
It's like, how do you help othergroups learn how to negotiate a
budget and things like that?
So I think the collaborationmight be more functional and
operational and less dealtrading like we used to do, but
(08:08):
I still think the sitecommunity...
is probably the best communityfor sharing.
People want people to besuccessful for the most part.
SPEAKER_00 (08:18):
One of the things I've heard from people, right or
wrong, and so I think I need youto debunk this or just back it
up, is that when you add sitenetworks and some of these new
network models to studies,you're actually decreasing the
number of sites on a studyoverall, meaning you put a
network in, and so if I wasgoing to select 20 investigators
in the U.S.
or 20 in Europe, I'm now goingto select 10 because the site
(08:41):
network is going to take theplace of the other 10.
On the average, is that true?
Is that just what people thinkhappens competitively?
SPEAKER_02 (08:48):
Well, I think, so it's true.
And as a matter of fact, it'sfunny because I hear some folks
say, pitching that today and itwas something we were doing at
Excelevance and So I mean,again, it's like the hula hoop,
here we are.
But I will tell you, John, it'strue.
And I think it's also indicationspecific.
So you're not seeing that inoncology and rare.
(09:09):
You're seeing it certainly ingen med, certainly in vaccines
where you need less studies fromthe population, where you can
actually get a multiplier offsome of these larger dedicated
clinics.
Absolutely.
I also think that there areinside larger TAs and indication
less studies level, like a CNSas an example, where there's
(09:30):
some CNS studies where you can'treally leverage it like that.
But there are other indicationswithin CNS where, yes, you can
get a little bit of a factor offof some of these network sites
so that you don't have to pullin as many.
And they're certainly sellingit.
They're selling it as a valueadd.
And I think for the most part,and this is the part that might
(09:53):
be a little mythological, isthat they're They're also giving
a discount, right?
So if a network comes in andsays, look, I've got 20 sites
that can knock the cover off theball, I'll give you an X percent
discount if you take all 20 ofthem.
I think there's some of thathappening also.
And again, there's value in thatfor the pharma sponsor.
SPEAKER_00 (10:12):
So when you talk about knocking cover off ball,
for those of you who don't know,that's a baseball term.
go Giants.
And if you think about what thatlooks like, what is that for a
high performing research site?
Like what is knocking the coveroff the ball?
And here, let me tell you my twocents.
My two cents is it's always beenabout recruitment.
It's always been aboutrecruitment, right?
Does the site have the rightpatients for this protocol and
(10:34):
do they feel like this is whatthey do all the time and they
can recruit these patients andtake care of them through a
study?
But now it's interesting.
I was with a friend who alsomanages the site and the
terminology he was using soundedso similar to what I use when I
talk about like contrasting froma technology firm to a
technology firm, right?
Where we, you know, not featureto feature, but like We as a
(10:57):
technology company do this andthis is why we're different.
What are those things besidesrecruitment?
What are the things that aredifferentiating or contrasting a
site from another site?
So they're winning the work andsomeone else isn't.
SPEAKER_02 (11:08):
You probably have to ask some biopharma clients that
because they're the ones thatare, they're the buyers for the
most part.
I think it comes down to acouple of things.
You know, to your point, firstand foremost, it's about
patients.
If you deliver the patients yousay you're going to deliver,
that's that repetitive processis what it is.
It's, I mean, coming back tobaseball, it's, you know, If
you're striking out all thetime, your coach is going to
(11:30):
bench you.
The biopharm is going to benchyou.
It's just not going to happen.
But I think there are a coupleother factors.
I think first off, it's speed tostart up.
So it's not just recruiting thepatients, but can you get your
study at a clinic up and runningfast so that those patients can
start accruing into the researchstudy?
I've always said, and I've saidthis for a very long time, that
(11:52):
really good sites recruitpatients, but the best sites
complete patients.
I mean, you know from the dataside, right?
Let's just say, for example,there's the phase two study
you're going to put 400 patientsin.
You know, the statisticiansalready factored how many folks
can drop out of that clinicaltrial in order to get that
complete data set.
Well, if you're a clinical trialsite and you're, you know, let's
(12:13):
just keep it simple, you'regoing to put 10 patients in, but
you only complete one of them.
You only get full data set forone of them.
You've left that sponsor highand dry on those nine other
patients.
So the focus is, again, is notjust driving recruiting, it's
engaging the right patients tomake sure that they fulfill
their obligation to study, whichwill help you fulfill yours.
So I think there's speed tostart up at the front end, which
(12:35):
a lot of the networks, theymanage that through central
solutions like reg, yourturnaround and contract
turnaround, things like that.
But then you look at theexecution, recruiting, yes, but
are you recruiting the rightpatients to get you that
complete data set?
SPEAKER_00 (12:49):
When you work in clinical research, especially on
the CRO side, a technologyvendor side, you're sort of
building Yeah.
Yeah.
(13:17):
you learn something new, right?
You see the real world and yousee the fact that some of the
things you work on don't cometogether perfectly.
And there's a lot going on,right?
And so I have a, you know, Ithink a different level of
respect for sites, especiallystudy coordinators, just knowing
what they do every day andunderstanding the complexity of
their job and how that's sort ofmoved to the next thing, moved
(13:38):
to the next thing all the time.
Let's say you're talking tosomebody who has, worked in
clinical research, but neveractually been to a site, never
actually seen a patient.
What do you recommend they do toreally understand that part of
business so they can apply thatto their thinking into their
job, regardless of where theywere in clinical trials?
SPEAKER_02 (13:56):
First off, it's a great question because I think
there are a lot of people thatcan conjure up in their mind
what a clinical trial site doeswithout ever having to being in
one.
So there are a couple of things.
One is, total side note, I sawon LinkedIn, speaking of
LinkedIn, that somebody followeda coordinator for a day and
they're like, that's the hardestjob I've ever seen.
(14:17):
So there's a lot of respect forcoordinators.
I have incredible respect foranyone at a clinic, from the
site manager all the way downand back up again, because what
they deal with in a given day,you can only imagine.
I mean, they're dealing withpeople and they're dealing with
physicians and they're trying tosow the two of those people
together.
And they're dealing with dataand monitors and technology.
and technology changing andpasswords changing.
(14:40):
So there's a lot that goes on.
At Accelivance, we actually hada site near our headquarters and
part of our orientation process.
I didn't care what role you had,but you spent a half a day in
our clinic to kind of marinatein that feel.
And you could feel kind of whatgoes on in a clinic in a half
day.
What I would tell people, if youhaven't been to a clinic, Google
your area.
I bet you there's a researchcenter you could drive to.
(15:03):
Call them up and say, look, I'mfrom this company.
I want to pop in and justobserve Even if you just sit in
the waiting room for 30 minutes,you'd be surprised at what you
hear and what transacts.
But I do think everyone's talkedfor years about patient voice
and site voice.
I think that's the site voice.
The site voice isn't hearingthem complain about a tech or
(15:25):
complain about a delivery orlack of delivery.
It's actually going to theclinic and understanding what
they have to go through on agiven day because stuff changes.
We're all human beings.
Human beings make mistakes.
know some of the mistakes aremade by the patients and the
sites there to help the patientkind of come back into the
clinic and make sure that thateverything's okay so i don't
(15:45):
have a good answer other thangoogle it and and go i think i
mean like if somebody googledone of our clinics and was like
hey look i just want to pop inand i mean obviously we'd have
them sign something but likejust come in i mean we love to
open our doors to people so thatthey they have a better
understanding for what it isthat happens inside a research
clinic for a research study.
SPEAKER_00 (16:07):
I'm pretty sure I was one of those people you made
go into one of the clinics.
I think so.
At some point.
I'm pretty sure I was, which isgood for me.
You know, I think we need to becareful.
So everybody in clinicalresearch, don't go sit in
everybody's lobbies at ourresearch site.
Yeah, don't
SPEAKER_02 (16:21):
stalk them.
Yeah,
SPEAKER_00 (16:22):
call it.
But I do, I think there'ssomething so important to that,
right?
Is that we, just like we see inpatient research, and we've
worked really hard to notbelieve we're the patient and
we're really not, and sort ofmaking decisions and not
listening and co-creating withpatients, we make a lot of
assumptions, right?
And we just assume, wow, that'show sites work.
That's what they care about.
Every time I ask thosequestions, and we ask healthcare
(16:43):
professionals, studycoordinators, those questions,
all the time, every time we do,the answers we get back are
usually different than how Ithink.
I think it's an importantreminder for us to keep that.
But listen, the flip side ofthis is you did bring it up,
this kind of terminology around,you said the word complaining.
I'm going use the word tension.
Because I do think, you know, ifyou log into LinkedIn, if you,
(17:06):
you know, sort of listen toconversations, you go to
conferences, you can heartension when it comes to
research centers, site networks,or research sites working with
different stakeholders inresearch.
And maybe that's mostly forLinkedIn clicks.
And I do kind of believe that toa certain degree.
But I also live in the realworld where tension is a part of
business.
And so I What's the tensionbetween sites and CROs, right?
(17:30):
And how do you overcome those tobe more efficient together?
How do these groups worktogether knowing they have maybe
some different businessobjectives?
But how do they make that work?
Because they've obviously beenmaking it work for quite some
time.
SPEAKER_02 (17:43):
Well, maybe they go visit sites more often.
I think, you know, so it's,look, to your point, I think,
for good or for bad, the adventof social media, I think 2012
was the tipping point.
We've talked about that beforewhere like suddenly now
everyone, everyone has akeyboard and has access to the
internet.
So I'm just going to lodge mycomplaints festivus for the rest
of us.
But I think when you lookspecifically at a clinic level,
(18:06):
I think the learning has to goboth ways.
So let me make that a little bitmore clear.
We just talked about going tovisit a clinic so you understand
that better.
I think there are a lot of sitesout there that don't understand
or don't really appreciate someof the decisions that biopharma
has to make on a day-to-daybasis.
And then the downstream to theCROs, they have to make
decisions based upon shippingcycles and IP viability, but
(18:32):
also technology and what'sworking, what's not working.
So I do think the learning cango both ways.
And I've done what I canspecifically inside Helios to
say, hey, look, we also have tounderstand that there's other
things going on know for thesponsor for the cro specific to
the tension i think it comesback to the same numbers that we
always hear which is at anygiven time well a trial running
(18:55):
at a clinic probably has 10different technologies and
there's all these passwords andthen there's a reliability that
there's an 800 number for thepatient to call but the patient
always calls the site so that'sone kind of you know fork in the
side of of the site levelbecause they're like hey look
you know I have to know thetechnology well enough to
support it and fix it at somelevel.
I mean, obviously notprogramming, things like that,
(19:16):
to make sure the patient isengaged.
I also think that there's a lotof pressure in research.
So look at the last two years.
The number of studies is lessthan it has been.
Studies are getting canceled anddelayed for various reasons
beyond a lot of people'scontrol.
And I think the pressure cookerthat transcends from the sponsor
to the CRO and then down to theclinic, and then there's that
(19:37):
pressure, right?
Look, to be brutally honest, inthe last 20 years, this always
flows downhill.
It flows downhill and the sitesare at the bottom catching it.
And so that tension, I thinksome of it is good for, for the
industry because you getinnovation.
You get things like embracingdecentralized trials.
You get things like embracingremote visits for the physicians
(20:01):
so that they can see thepatients in the clinic, but also
have video conferences.
I think you get embracing someof this new technology that way,
but it does come with headaches.
And I think the headaches areborn, or at least the sites feel
like they bear most of thatproblem, which I can understand.
It's not like, you know, CROsand sponsors wanting to hurt
(20:22):
them.
You know, it just happens.
SPEAKER_00 (20:25):
Talking about that tension too, if you take it and
let's move it over to patientrecruitment and patient
recruitment companies.
Yeah.
What's interesting is I havefriends, good friends that run
and own sites.
And I have good friends that arerun and built patient
recruitment companies.
And somebody recently said,well, you know, sites, we don't
like recruitment companies.
(20:45):
And I went, what?
When did this happen?
And so like debunk that for me.
Is that really true?
Or is there some kind of atension between the two that
sort of makes that relationshipcomplicated?
SPEAKER_02 (20:54):
I might have started this thing 20 years ago.
So the reason why I say that, Imean, honest to God.
So you have to remember, mybackground was finance and
technology.
I came into research.
And within five months, we wererunning our first multi-site
study as we were a subset ofsites on a phase two multi-dose.
(21:18):
It was a five-dose vaccineprogram.
I know it's a shocker, everyone,because I think most people just
thought vaccines started duringCOVID, but they've been going on
for a while with thosedinosaurs.
They have.
So for us, we had eight clinicson this trial.
And the trial was for...
I'll just say it was foranthrax.
I couldn't figure out why no onewas like, we weren't getting any
patients.
(21:39):
It was a central campaign.
We weren't getting any patients.
I called the CRO and I'm like,there's something wrong here.
We should be getting tons ofpatients.
We had clinics in areas thatshould see these people.
So they sent me the ad and itwas, I don't know what font
level that is, but it's like thesize of my head.
It said anthrax.
So I could imagine people, nowagain, 20 years ago, people at
(21:59):
bus stops, like just throwingthe newspaper down because
anthrax, This was in 2005.
It was four years after 9-11.
So I could imagine peoplerunning away from newspaper ads.
Long story short is that I thinkthe tension is that sites,
network sites particularly, likesites that have a central group
that does their recruiting forthem, they feel like they know
(22:19):
their city.
They know their town.
They know where they live betterthan some large...
third-party vendor who lives ina different state and doesn't
know anything about where theylive.
And to be honest with you,there's some truth to that.
We've run A-B sampling onrecruiting, and our recruiting
(22:40):
messages ring truer to ourpatient population, whether it's
in clinic, like through EHR, oroutside of clinic through social
media, better than a thirdparty.
I think some of it, theyremember, like sites will
remember that one time that thecancer patient was sent to them
that had the wrong tumor type.
They'll remember that for 15years.
(23:02):
They won't let go of it.
So I think some of it is, istrust.
You know, I think some of it is,is that is, is the models.
There are actually some reallygood recruiting companies now
where their financial models,they get paid for like screen,
like actual randomizations, asopposed to just throwing people
in a clinic.
So, Hey, we sent this clinic ahundred people.
Well, yeah, you send a hundredpeople that have no interest in
(23:24):
research or they don't evenunderstand that you reached out
to them for research, which isalso part of the disconnect.
So I think some of it has beenthe modeling.
And I think some of it also isthere's sites that do it really
well.
So now go backwards.
Earlier in our conversation, wewere talking about go to the
right site for the rightpatient.
Maybe deploy these third-partyvendor recruiting vendors to the
(23:44):
sites that need the help and noteverybody.
Don't make it aone-size-fits-all.
Make it optional for some sitesthat actually know how to
deliver patients.
And maybe that would help solvesome of this also.
SPEAKER_00 (23:56):
Yeah, it's interesting.
I think this fit-for-purpose usecase is always the understanding
we use.
And the A-B testing just stillto this day shocks me because
someone will, you know, just inmy daily work, someone will come
in and say, hey, we seeadvertisers doing it.
We say, have you asked patientsto actually review these?
And they'll say no.
And I'm like, doing?
(24:16):
Like ask patients, they'll A, B,C, D, E, F test this for you and
tell you what works in thatregion.
And I think it's, you're right.
When you're a site, you alreadyhave an inkling of what that
looks like because that's yourarea, right?
It's where you live.
SPEAKER_02 (24:28):
Your point, I think it's good for purpose.
I think one of the, one of thegreat things about research,
which is also one of thosedownfalls is that if you can, if
you can customize everysolution, you'll deliver a great
study, but it's hard tocustomize every solution where
you're trying to go, you know,multi-site, multi-studies, maybe
in the same therapeutic area youhave, you're targeting four
(24:51):
different indications like incancer.
Well, you can't do customizeddown to that level.
You'll just be spending way toomuch money.
And I think some level, some ofthese groups, the recruiting
groups, they do a very good job.
I just think that if they had alittle bit more skin in the
game, you'd find that they do areally good job for like
independent sites and maybe someof these groups that don't have
(25:12):
the central service already inhand.
SPEAKER_00 (25:14):
When you think about a site too, a research site,
regardless of if it's anindividual site, a network, an
SMO, an ARO, whatever that modelis, we keep talking about
different people that areservicing.
Their job is to support the siteso that they can recruit and
take care of the patients in theclinical trial.
That's the point.
And we're talking about CROs andrecruitment companies.
(25:35):
There are lots of other vendors,lots of other companies we could
talk about.
And there's always tensionthere.
I've grown up.
In the last 10 years, seeingmore and more tension between
technology and sites.
As you try to get that balanceright, From a site's
perspective, if you could juststart a tech company and say,
I'm trying to address these gapsthat we see no matter who we're
working with in the market.
(25:55):
Give me like one to two nuggets.
What's the thing that you and I,Evie, would go build to service
that gap so that sites wouldfeel even more supported or more
enhanced by the technologiesthey use?
SPEAKER_02 (26:07):
Wow, that's a loaded question.
I think I'm going to hit twoquote-unquote simple things.
simple solution.
And again, it could just be us.
Half the time I look at it, I'mlike, maybe it's just an us
problem.
But one thing that I know fromhaving multiple Helios sites on
the same study is that we go inand we'll ask a question And if
(26:32):
site A asks it to a monitor,site B asks it to a project
manager, site C asks it to theirmonitor, we might get three
different answers.
And so I know there have beenmany attempts to try to white
glove these types of solutions.
There have been attempts tocentralize communication.
I actually think there might bea chance now with the advent of
(26:52):
AI to actually do a voiceover ofwhat those answers are.
I mean, to actually let AIdevelop kind of the FAQ for a
study.
And then it knows it so thatwhen you call in, it's giving
you a centralized standardanswer for some of these
questions, because some of themare obviously more complex and
might need a little bit of ahandholding, but there are a lot
(27:14):
of them that are just kind oflike pretty simple and it's hard
to get a common answer.
So that's, I'm trying to thinkof like new tech and maybe kind
of a, kind of a little sidething there.
So that would be one is there'sa way to get a better way to
communicate the front end goinginto the study, better questions
(27:35):
and answers that are common andanswerable.
That would be one area.
I think the other area, and thisis something we've been, and I
know you guys do it yourselves,is source is the single source
of truth.
But here you have us who like weuse, resource.
And then we have to go into anEDC system.
(27:57):
That EDC system could be off theshelf product.
It could be something thatpharma has been using for 20
years, whatever it is.
So we have to take our sourceand then align it into their
CRF.
Now we use CRF guidelines to,you know, to make sure that
there's some alignment, but likeall we've done is taking double
data entry off of paper formsthat you as a monitor used to
(28:19):
mail in to a central office.
Now it's just all it's done isdistributed that workload to a
clinic.
So we're doing double data entryin our clinic.
There's gotta be a better way todo that.
And then you add a thirdelement, right?
Because there are a lot ofclinics, especially when you
start talking about you know,harder to treat populations with
rare CNS and oncology, where youwant to get some of those data
(28:40):
points back into the medicalrecord because it might
intertwine with standard ofcare.
So now you're taking data frome-source, putting it into your
medical record and then back andthen into EDC.
And I know, again, I knowthere's some groups out there
that are working on EDC to EHRand that connection or EHR to
EDC and that connection.
But really, it's the source thatwe need to figure out a better
(29:02):
way to just use that as aunifying solution because that
is taken it's taken at the visitit's the truth of what happened
at that visit it seems to methat there's a better way to use
that as opposed to thenmulti-layers of other data entry
that all it's done has just beendistributed back to the clinics
SPEAKER_00 (29:19):
there's one or two things you know about me you
know i'm not a fan of the casereport form and frankly i've
been on the tear for years toeliminate it yeah because i'm
with you 100 i feel like sourceand direct data capture has been
around a long time and it'scoming because persistence wins
in this industry, right?
It's coming.
But do all sites, researchsites, feel the same way you do
(29:41):
around, if I were to say, hey,there's no case report form,
you're just going to directenter here, and then we're going
to get this back in your EMRthere, and you're going to have
less monitoring and oversightrequired, so we're going to get
out of your way a little bitmore.
Is that advantageous to sites,or is there a component of that
that's too far for researchsites on the average?
SPEAKER_02 (29:58):
Well, I think you just hit on something that might
be too far for a lot of sites,which is everyone's like less
monitoring makes sense but wewant monitoring i mean to be
honest with you one of thevalues of a site network is that
most if not all of them i thinklike 99% of them are going to
have some quality departmentthat are looking, they're doing
their own quality checks on databefore the monitor ever comes
(30:20):
because they want to show thatthey've got good quality data,
which is again, a value ofhaving a network.
So I think if instead of yousaying we're throwing monitoring
out, I always look at it as ifyou can remote view data and reg
as an example, then when themonitor actually does show up on
site, they have much moremeaningful interaction with the
(30:40):
physician and the site teamabout their operations?
How's the study actually going?
As opposed to, I saw fivetransposition errors in the data
or whatever.
I mean, that's like easy, basic.
But I think if you did a survey,which I would highly recommend
you do, I think a lot of siteswould be all on board for a
single point of data entry.
(31:01):
And then whatever happens,whether it's a data lake,
whatever body of water it goesto, people get what they need
out of it.
And they can evaluate.
Because to be honest with you,if you actually did that, and I
won't be confused with astatistician, but I think if
you're getting that data pumpedin real time, and real time
means different things todifferent people, but on a daily
(31:21):
basis, the statistician is goingto be able to flag what looks
weird pretty quickly.
I mean, the data scientistsshould, at a minimum, be able to
go, well, here's something weirdhere.
Let's go back to the clinic andask them that question.
But what it does for you is allof a sudden it starts letting
you look across your entirestudy and really understand
what's happening with yourpatient population.
(31:42):
And you're more in tune with therhythm of the study, I think,
faster than you are when you doyour regular data cuts.
Because you're doing data cutson, you know, here's the source
data, but you're doing data cutson something over here, you
know?
And so I think sites, look, theburden of, I'll just keep
calling it double data entrybecause that's what I see it as,
is, I mean, it's a real thing.
And I think most sites would,they would appreciate a
(32:05):
streamlined way to do that withmonitoring that site so that
they make sure that they'redoing what they should be doing.
Because you have to remember,there are a lot of independent
sites.
If you ask an independent site,not 100% of the time, but if you
ask them how they manage theirquality, they would tell you,
well, that's what the monitor isfor.
SPEAKER_00 (32:23):
Yeah, I totally get that.
Well, eliminate the CRF, reducethe monitoring, not eliminate
SPEAKER_02 (32:28):
it.
Yeah, you reduce that data, muchof the data component, and then
you look at You can look at morelike problem resolution, right?
And root cause stuff.
SPEAKER_00 (32:39):
One of the key questions that I hear often, and
I don't know if I've ever had areally good answer for it.
So I've got a CEO of a sitenetwork.
I'm just going to ask you.
Is recruitment is so much of thechallenge of getting studies up
and running, right?
So tech firms and companies likethe ones I work for, you know,
we typically get, hey, how fastcan you start up?
But the reality is we can startup as fast as we want.
We still get into recruitment.
(33:00):
You get the FPI rolling andrecruitment is still your
biggest driver.
of delaying in clinical trials.
And we all know all the metricsabout how expensive that is, how
much time that is, how mucheffort it is.
We know that.
What's the thing that couldchange that could help us
recruit faster?
Is there something that needs tohappen or something that hasn't
been happening in the last 30years that someone hasn't done
yet that could really help sitesbe free and give them more
(33:24):
autonomy, give them moresupport, give them more funding,
whatever that is that would helpthem recruit patients faster so
that this research could be donemaybe six months quicker?
SPEAKER_02 (33:33):
Well, John, if I had figured that out, I'd be retired
right now.
So I think...
you know, let's take a stepback, right?
I remember 2008, the focus ofDIA that year was patient
centricity, 2008.
So here we are, 17 years later,we have more websites, we have
(33:54):
more recruiting companies, wehave more people talking about
research, but the samepercentage of physicians and the
same percentage of patientsparticipate.
Now, to be honest with you, Ithought a pivot point was COVID.
Because I don't know about you,but finally, after being in the
industry at that point for over15 years, my family finally
(34:17):
understood what I did for aliving.
But it was on the news all thetime.
And you could go to arestaurant.
People would talk about pivotalphase three studies.
It's like, wow, you're speakingmy language.
Well, then, unfortunately,obviously, a lot of things have
happened since then that havekind of sour people or dampen
some of that enthusiasm.
(34:38):
But I think there's still amoment of education.
I think that's what a lot of thegroundwork that these site
networks do very well is theybring patients in for
biospecimen studies, a simpleblood draw or a flu shot.
Hey, look, you get your flu shotover here, try a research study.
You bring things in forsomething that people know
about.
And then suddenly they're like,well, that wasn't so bad.
(35:00):
I didn't feel like a guinea pig.
I didn't feel like I had an X onmy head and I was sitting in the
corner all by myself.
Like I felt like I was part ofsomething interesting.
And then when they actually havesomething where they need
research, they're not afraid.
And I think the more we do ofthat, the better we're going to
be.
And to be honest with you, Ithink the last five years of
(35:21):
these site networks spinning upwhether it's private equity
invested or self-funded becausethey got some cashflow out of
COVID.
And so they're starting to revup their engines.
I think the more that thisbecomes professionalized at a
clinic level, the moreparticipation we will get.
I think it's, you know, researchis definitely professionalized
at the biopharma level.
(35:42):
It's definitely professionalizedat the CRO level.
And I think now we're seeing theadvent of being professionalized
at the trial site level.
SPEAKER_00 (35:49):
Shifting gears a little bit to that term around
patient engagement, patientcentricity, Yeah.
(36:13):
We knew that a lot of solutionsneed to be developed thinking
about and being in the shoes ofa patient and working as opposed
to being a sponsor of CRO andworking in.
I'll admit, it happened to metoo.
It happened in my company.
We spent so much time on thepatient first that it
overshadowed the critical roleof clinical sites and how we
(36:34):
thought about them.
And so in our business, wereally focus on the patient
piece first.
Then we moved to the siteportal, another piece second.
And just because that's what wehad to do, But at the same time,
it was a pretty common story,right?
Where sites were saying, hey,listen, you're over-indexing on
the patient.
Come meet my needs.
Come help me do this.
And so tell us, EB, how do we asan industry understand be more
(36:55):
balanced in this and stillthinking about supporting the
patient experience, butsupporting and thinking about
the site and the site as theuser that is the conduit to the
patient.
How do we do a better job ofthinking that way and acting
that way?
SPEAKER_02 (37:07):
Yeah.
Again, it's not that it's aloaded question.
It's like, where do you, to yourpoint, it's like, where do you
start?
Right.
So I think there's been, A lotof progress made in engaging
with patients in protocoldevelopment, things like that,
great.
Engaging with sites, protocoldevelopment, that's great.
I think maybe what we'retripping into here is the
(37:28):
operations side, right?
Let's be honest, the CRO doesn'twant a site telling them how to
run this.
Maybe you do, but they don't.
I think for the most part,right?
And so like, what's the learningthere?
And I think if you had, even tostart with a blank piece of
paper and say, we're just gonnado 100% tech-based, research.
Like all we're going to do,we're going to engage the
(37:49):
patients directly.
We're going to put them in, youknow, to a site if we need them
or the pharmacy, if we just needa blood draw or a shot or
whatever.
I mean, like if we just went toNova with a blank piece of
paper, to be honest with you,you probably end up kind of
where we are anyway.
I think, I think you'd end upwhere we are.
I could be wrong because youstill need at some level.
(38:10):
And again, this isn'tubiquitous.
So, you know, there are a chunkof studies where you can go
decentralized.
where you can do something likethat, where you just take a
blank piece of paper and say,how do we get this patient, like
give them the Amazon experienceof research, right?
Or the Walmart experience, like,oh, it's in aisle four.
Let me go down there and look.
How do you give them that?
That hits certain indicationswithin therapeutic areas, but
(38:33):
it's really hard to do a phaseone oncology study that way,
right?
A vast majority of the studies,you still need that PI, you
still need the site.
So to your point, how do youwork with them in a better
manner?
I think in research, the sitesjust want to give good patients,
give good data.
So instead of throwingeverything at these sites and
coming up with all sorts ofnuance, why don't we just throw
(38:56):
the things that are needed?
How do you get the best qualitydata from a patient with XYZ
indication in a phase twosetting at the right site?
And those sites will tell you,here's what the patient will do,
here's what they won't do.
Here's what the doctor will do.
Here's what the doctor won't do.
And you almost have, we have keyopinion leaders.
You almost need these siteoperation key opinion leaders.
(39:20):
So close.
Coming up with new vernacular.
But you almost have to havethese site operations folks that
have been doing it for 20 yearsor more because they've lived
through the tech piece and thenthe down and then the back up
and fully decentralized themback down.
We've been doing hybrid studiesfor 15, 20 years.
So it's not new.
It's just what's the right piecefor this type of technology?
(39:40):
So I think some of it is comingup with a better shopping list
to go through and find the rightpieces to deliver that, right?
Like everything is a bit of amosaic.
And the reason why I say amosaic is that some of those
colors, they intersect.
And I think in research, we haveto look at it as what's the
(40:02):
right site combination with theright patient like what patient
are looking for what's the rightsite combination to get that
patient then overlay what thepieces are that make them
successful and to your earliercomment it's not about what you
think is going to make themsuccessful it's about what they
think is going to make themsuccessful and it might it might
be just a little bit differentit might be the same system but
(40:23):
instead of having five differentthings they're doing in it
they're only doing one or twoand that's going to get you that
better data
SPEAKER_00 (40:28):
i think i've heard it
SPEAKER_02 (40:29):
probably 150
SPEAKER_00 (40:29):
times.
And I heard it again.
It was on the phone researchsite.
It was a study coordinator at aresearch site.
And the way she said it, samething I've heard before, but I
needed to hear it again.
And so I'm going to say it outloud and you can tell me if it's
bad advice or not.
But she said, John, the tech isgreat.
The people are nice.
I don't remember what studyyou're calling about.
Could you guys just make sureyou all do a better job in
(40:51):
context?
Know that in your world, you'vegot these things and you're
like, you're doing this.
My job is context switching.
every four and a half seconds.
So I am frantic.
I've got a patient in theclinic.
I've got the doctor needs to seehim.
I get on the call and people go,hey, could you check this and
check this?
And I'm still thinking, is thisthe star study that I'm working
on?
That's where I'm at.
(41:12):
And so she said, hey, the thingthat I wish people would do is
not just all the strategy thingsand listening to us about our
opinion on the protocol and thepatients and where to get them,
which I think are all super fairpoints because they're the
experts.
But that reminder just to say,just give me the context.
Just make sure you're repeatingthat because I've got a lot of
these going on and I can'tremember them all.
(41:33):
And I think it's so many timesit's the simple stuff, right?
It's the simple things that helpus to be more thoughtful and
empathetic about I'm workingwith the site.
They've got a lot going on.
This is what it's like to be ata site, just like all the things
you mentioned.
And so if I understand that, I'mgoing to come in this
conversation very differentlyand have a soul about it and
say, hey, how can I help you?
And so I need to do help you getin, get out, get what you need,
(41:54):
but give the context.
And for me, that was reallyimpactful.
And I said it to my team becauseI needed to hear it again.
SPEAKER_02 (41:59):
Yeah, no, I think it's a fair point.
And again, it's the day and agewhere we're at, where a research
coordinator might be working ona handful of studies.
A monitor might be working onone.
So for that monitor, when theycall in, that's the most
important question that they'reasking.
But meanwhile, the person thatthey're calling just finished a
visit on a totally differentstudy, is preparing for a visit
(42:21):
on a totally different studythan that one.
And this person just happened tobe at their desk.
They picked up the phone.
And now to your point, they'rejust saying, hey, look, I'm
calling about this.
And they're like, wait a minute,my head's spinning because
that's not where I am.
Like, that's not where I amright now.
So I think it's a good point.
I think it's also hard at thesite level to be present in that
moment.
to also be there to listen.
(42:42):
And maybe that's where some ofthe tension comes from too.
SPEAKER_00 (42:44):
If I'm a person working in clinical research and
I'm interested in working in asite or a site network, right?
I'm hearing these terms.
I say, hey, I've got goodexperience or maybe I'm new and
I'm trying to get into clinicalresearch.
And I believe that learning at asite network might be the best
early stage of my career.
What do you tell them?
What advice do you give them tolook at that route?
And then second is when theysay, great, after all that EB,
(43:05):
is AI coming after my job?
What do you say to that part ofthe question?
SPEAKER_02 (43:09):
So the The first part, as a side note, I'll tell
you that the people that I'veworked with at different CROs
and different sponsors, the bestpeople have worked at a clinic
somewhere in their career,somewhere along the way.
I think it's actually a prettyvaluable part of your own
learning as you're in research.
And again, I'm a little bit...
(43:31):
Just a little.
Just a little.
But with that said, if somebodyreally wanted to get in, I would
tell you, look in your area andsee what sites are there.
You might have to be willing todo some work that you didn't
think you're going to have todo.
in order to grow into it.
Because there are some peoplethat think very highly of
(43:52):
themselves and they're in theirmid-20s and they've done
something and now they want toget into research.
They're like, well, wait aminute, I'm at this level and
now you're putting me at thatlevel.
It's like, well, yeah, but ifyou want to actually get to this
level of research, you got tostart somewhere.
So if you're going to be in aclinic, you might start as a
patient recruiter.
You might start as a datamanagement person.
You might start as a researchassistant, depending on your
(44:13):
background.
And all I can tell you is, ishang in there.
And if you get in If it were me,I would ask whatever group I'm
applying to or talking to islike, what is your training
program?
I don't need to know I'm goingto be a next level in three
months or six months.
It's like, just do you have aplan for me?
Or is it just like I just haveto gut it out?
Because one of the issues thatsites do have is once you get to
(44:35):
a certain level, there's It'srarefied air at some point,
whether it's a regional manageror even a site leader, that
might be the best you can do inthat particular group until you
actually become an executive.
And there's not as many of thoseroles available these days.
So my point is, is if you get inand you learn, then you can
start seeing these differentoptions and you start seeing
(44:57):
what else is out there inresearch and be a part of it.
And then on the AI question, Imean, I hate to be the person
who says it's not going toaffect sites as much, It's going
to affect everybody.
I mean, there's ways to be moreefficient and effective with
your own time.
I think it's going to make aneffect on sites.
When I look at what coordinatorsdo and the things that they do
(45:17):
with patients, especially in theharder to treat populations, I
think it's going to be hard toreplicate that with AI.
Mostly, I mean, you used theword empathy before.
When you're dealing with latestage cancer patients, you're
talking about people that needhandholding.
They need care.
They need to be consoled fromtime to time.
And you can't get that from AI.
You can get that from a reallygood coordinator who's been
(45:40):
through it with other patients.
And I think that's whereresearch sites separate
themselves from paper pushers.
Yes, they're delivering data,but it's coming from a human
being, not from some chartonline.
I always say that when yourandomize patients into a study,
it's a walking lab.
I know it doesn't sound great,but it's a human being.
(46:02):
It's their biology and theirchemistry that's taking over
that study.
And you have to tether thatperson into the study.
And for us, that tether is thecoordinating staff.
It's the site.
You know, a lot of our patientslove to come to the site.
They'll still do the remotestuff.
They'll still put in theirdiaries.
They'll still have a remotevisit if they need to.
But they love that interactionbecause that's where they get
(46:23):
empathy that they might not getfrom tech.
No offense,
SPEAKER_00 (46:27):
John.
Total offense.
And it should be.
It's the way the world shouldwork.
This whole world, in my opinion,right?
But it's my podcast, so I get togive all my opinions.
Thank God for that, right?
You know...
this whole world is hybrid and Ikind of don't want that to
change.
I love the intersection of techand people and we've got to get
this stuff right.
That's how we move it forward.
(46:48):
That's how we're more inclusive.
That's how we actually changethis market.
So no, I appreciate that.
I think it's really important.
SPEAKER_02 (46:54):
And I tell our team, I mean, I've been trying to
figure out ways to utilize AI atthe site level and there are
ways to do it.
I'm not going to share all thesecrets on your podcast, but my
point to them is it makes youmore efficient and effective
with your time so that you havethat time to spend with your
maybe with your peers, but alsowith the doctor and with the
patient, because that you can'treplicate.
SPEAKER_00 (47:15):
If I'm a research site and I'm maybe not tech
savvy, I'm definitelyconsidering just starting with
the basics.
And the basics are meetingminutes, notes, question and
answer.
One of the things I saw from asite, and I know somebody got
mad at me for posting this, butI said, you could use ChatGPT.
You did some research and youwant to create an ad for for
recruitment locally that wasmore fitting.
(47:37):
It was inclusive of the peoplein your community and you wanted
to go design that ad.
You knew exactly what it lookedlike.
You had the template.
You could go build it.
Things like that I think aresuper practical, really
efficient ways for sites to usethese tools, but not going too
far yet.
Let's just get the baby steps.
Start using them.
There's so many directions wecan go.
I want to stop here.
(47:57):
Let's just bookend becauseresearch sites and networks, now
they work, was...
Just so much valuableinformation.
So EB, thank you.
Thanks for taking time today.
If someone wants to connect withyou or learn more about what
you're up to, what's the bestway to reach you?
SPEAKER_02 (48:10):
I'm a fan of just giving out my cell phone number.
I've been told not to do that inthe past, but I just give it
out.
So you can call me or text me oryou can find me on LinkedIn,
just EB McClendon.
SPEAKER_00 (48:21):
And I'd encourage you, if you're looking for a
site network and just anall-around guy that knows the
space that you want to connectwith, EB is your guy.
EB, thanks for your time.
Good to see you.
UNKNOWN (48:30):
I appreciate it.
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