Interested in research? Check out the links below to get started!
The Collaborative Institutional Training Initiative (CITI Program): The Trusted Standard in Research, Ethics, Compliance, and Safety Training
Good Clinical Practice (GCP) Online Training Courses
Human Subjects Research Courses
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Step into the mysterious world of clinical research with Leigh Shermer, a Physician Assistant and Doctor of Medical Science who's breaking barriers in an area traditionally dominated by physicians. With over 18 years of healthcare experience across cardiology, critical care, and cardiothoracic surgery, Leigh now leads clinical trials that develop the medical treatments of tomorrow.
What exactly happens during a clinical trial? Leigh pulls back the curtain on this fascinating process, walking us through the careful protocols, patient safety measures, and day-to-day operations of a clinical research site that might be running 40 different studies simultaneously. Far from the stereotype of researchers working in isolated labs, she describes hands-on patient interactions, thorough safety monitoring, and the delicate balance of following strict scientific protocols while providing compassionate care.
Perhaps most compelling is Leigh's insight into why patients choose to participate in clinical research. Some join from altruism, wanting to advance medical knowledge. Others seek access to treatments for conditions they couldn't otherwise afford. And yes, some participate for financial compensation – a practical acknowledgment of the time commitment these studies require. In all cases, Leigh emphasizes that patient safety remains the absolute priority, dismantling the misconception that participants are treated as "guinea pigs."
Leigh's career journey itself tells a powerful story about the evolving healthcare landscape. Her transition from cardiothoracic surgery to critical care to cardiology and finally to clinical research demonstrates the remarkable versatility of PA careers. Interestingly, it was the COVID-19 pandemic and her curiosity about vaccine development that sparked her interest in clinical research, eventually leading her to earn her doctorate and pioneer new roles for PAs as principal investigators.
Subscribe to Shadow Me Next for more fascinating conversations that take you behind the scenes of healthcare careers you might never have considered!
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Ashley (00:00):
Hello and welcome to Shadow Me Next, a podcast where
I take you into and behind thescenes of the medical world to
provide you with a deeperunderstanding of the human side
of medicine.
I'm Ashley, a physicianassistant, medical editor,
clinical preceptor and thecreator of Shadow Me Next.
It is my pleasure to introduceyou to incredible members of the
(00:22):
healthcare field and uncovertheir unique stories, the joys
and challenges they face andwhat drives them in their
careers.
It's access you want andstories you need, whether you're
a pre-health student or simplycurious about the healthcare
field.
I invite you to join me as wetake a conversational and
personal look into the lives andminds of leaders in medicine.
(00:43):
I don't want you to miss asingle one of these
conversations, so make sure thatyou subscribe to this podcast,
which will automatically notifyyou when new episodes are
dropped, and follow us onInstagram and Facebook at Shadow
Me Next, where we will reviewhighlights from this
conversation and where I'll giveyou sneak previews of our
upcoming guests.
I'm thrilled to introducetoday's guest, lee Shermer, a
(01:07):
physician assistant and doctorof medical science, who is also
a trailblazer in the world ofclinical research and a true
advocate for PAs and roles youmight not expect.
With over 18 years of experiencein healthcare.
Lee has worked acrosscardiology, critical care and
cardiothoracic surgery, but it'sher current role as a principal
(01:29):
investigator andsub-investigator in clinical
research that sets her apart.
Lee's journey into clinicalresearch was sparked by her
curiosity during the pandemic,especially around the rapid
development of vaccines.
Now she's leading trials indiverse fields, from psychiatric
studies to cardiac research,ensuring patient safety and
(01:50):
pushing the boundaries ofmedical advancements.
She shares how being a PA inclinical research is anything
but behind the scenes work.
It's hands-on, patient-focusedand absolutely vital to the
development of new therapeuticsand devices.
Focused and absolutely vital tothe development of new
therapeutics and devices.
In this episode, leigh takes usbehind the curtain of clinical
(02:12):
trials, explaining thedifference between principal
investigators andsub-investigators, how patients
are selected and sometimesrejected from clinical trials,
the importance of safety inclinical research and how she's
helping to reshape the role ofPAs in this growing field.
If you have ever wondered aboutthe cutting edge of medicine
and the real impact of clinicalresearch, this is an episode you
(02:34):
won't want to miss.
Please keep in mind that thecontent of this podcast is
intended for informational andentertainment purposes only and
should not be considered asprofessional medical advice.
The views and opinionsexpressed in this podcast are
those of the host and guests anddo not necessarily reflect the
official policy or position ofany other agency, organization,
(02:56):
employer or company.
This is Shadow Me Next withLeigh Shermer.
Leigh, thank you so much forjoining us on shadow me next
today.
I am thrilled that you are hereand you have a very unique role
in medicine, and so the factthat we are talking about this
is just something of my dreams.
So thank you so much for beinghere and joining us.
(03:16):
Yes, thank you so much forhaving me, ashley.
So, lee, tell me, tell me whatyour title is, and then tell me
what you do on the day-to-daywhen you come to work.
You are a PA, but your lifelooks very different than my
life.
Leigh (03:32):
Yes, so I work in clinical research.
I am an investigator, generallya sub-investigator, but I have
been on some studies where I'mthe principal investigator,
which I'm sure we'll get into ina little bit.
But basically clinical researchis a field of medicine where we
(03:53):
do the beginning stages ofresearch so that we can help
take care of people.
And you know, in clinicalmedicine we're used to
prescribing medications after wemake diagnoses and things like
that, and this is like thebeginning work and we, you know,
are sort of behind the scenesin a different area of medicine
(04:14):
where we are doing trials fordifferent therapies, whether it
be vaccines or therapeutics, soyour typical medications that
might be prescribedantihypertensives or
therapeutics.
So your typical medicationsthat might be prescribed
antihypertensives, statinmedications and all sorts of fun
other things you know, like theweight loss medications, which
are really a hot thing right now.
Ashley (04:34):
That's fantastic.
So, investigator, tell us moreabout this.
You mentioned two differenttypes.
What are the roles that both ofthose play?
Keep in mind that there's moreinterview prep, such as mock
interviews and personalstatement review, over on
shadowmenextcom.
There you'll find amazingresources to help you as you
prepare to answer your ownquality questions.
Now, lee and I did not discussa quality question, but from our
(04:58):
conversation, there was onetopic that would make a
fantastic interview question howdoes clinical research improve
healthcare and what role do PAsplay in advancing these
improvements?
This is going to be what westart to see in the future, and
being able to answer thisquestion during an interview
(05:18):
will set you apart from many ofthe other applicants.
Leigh (05:22):
Yeah, so an investigator is like a medical practitioner
of some sort who is seeingpatients and determining their
eligibility and safety duringtrials at the beginning, before
they even get into a trial perse.
Generally the role of aprincipal investigator has been
(05:42):
that of a medical doctor or aPhD or a dentist, for example.
There are certainly others aswell, but it's generally been a
medical doctor, when you talkabout clinical research, for
many of the trials that we do,and they are basically in charge
(06:03):
of, responsible for the conductof the trial, and everyone that
participates in the trial froma site standpoint or from the
research site standpoint isunder that principal
investigator's sort ofdelegation.
So they're delegated by theprincipal investigator to
participate in the trial becausethey have the qualifications to
(06:26):
do so.
The sub-investigator role,which is generally something
that is more suited to PAs, nps,but certainly also physicians
and others, can be alsodelegated to the
sub-investigator role.
It's generally somebody withsome sort of medical degree can
(06:48):
basically do all the same thingsthat the principal investigator
would do, but they're delegatedunder the principal
investigator to do those thingsbecause they have the medical
qualifications to do so.
So they would still do, youknow, taking history and
physicals, ensuring thatpatients meet the criteria to be
in the trial, they're safe tobe in the trial and all those
(07:10):
type of things.
So it's exciting.
There's a lot to the role, theinvestigator role.
I certainly didn't knowanything about it until I
started to research, you know,getting into clinical research
you know, getting into clinicalresearch.
Ashley (07:28):
It is fascinating to me, and here I am thinking in
clinical research you're justyou're sitting behind a desk all
day and you know running,running tests and and messing
with computers and equipment,and it turns out there's there's
an entire clinical side to this, right.
I mean, it is still directpatient care, from what it
sounds like.
Leigh (07:43):
Yes, yes.
So the nice thing aboutclinical research is it's not
your typical kind of chemistrybehind the bench doing
laboratory studies.
This is a whole different field, but this remains clinical, so
that's the piece of it that Ireally love.
So, generally, these are eitherI work at the site level, so I
(08:03):
work at a standalone clinicalresearch site Actually, we're
part of a network now, which iscool, but I work at a standalone
site and other sites might beunder.
You know a university and thatyou have different departments
within the university that runtheir own research, but I
actually work at a clinicalresearch site.
It's been around for about 30years.
(08:24):
We do all sorts of differentresearch as I mentioned vaccines
and therapeutics but I get tosee patients every day, which is
really great.
So we see patients.
When they come to us and theywant to get in a trial, we
determine their eligibility todo so and then see them
throughout the trial atdifferent visits as needed, and
(08:46):
basically everything is off of aprotocol that has been sent to
us or has been created bycertain sponsors, and when we
say sponsors, those aregenerally pharmaceutical
companies or device companiesthat make up protocols and we
are in charge of following themto a T.
So it's nice we see all sortsof different things.
(09:08):
The protocols are varied,especially in you know how
complicated they are, but itcertainly gets me thinking.
Every day and no two days arethe same the type of patients
that I see run the gamut betweenpsychiatric style, different
studies, cardiac studies, gistudies, neuro studies.
(09:29):
So it's really I see see a lot.
Ashley (09:33):
Now is that.
Would that all be like in thespan of one day?
Do you have different patientscoming in for different clinical
studies throughout the entireday, or do you have like Monday
is your psychiatric study andTuesday is your cardiovascular
study, and so on and so forth?
Leigh (09:48):
Yes, so at our site we have about 40 active studies
right now, so it's a lot.
We are very busy, yeah, andmost days are mixed in, so you
have patients coming in from allthe different studies, which is
really pretty neat.
The only time that we wouldgenerally have a full day of the
same patient would be if wehave, like, if we're enrolling a
(10:11):
high, high volume vaccine studyor something, and then you
would see patients for the samestudy all day.
That's just the way we.
We would do it.
We call it like a bulk daywhere we would just see the same
, just to make it easier.
So the staff you know sort ofknow what we're doing and kind
of go from there.
But most days are very varied,are varied, and so that works
(10:35):
out well and keeps things fresh.
Ashley (10:39):
How do you keep all that straight?
I mean, I'm just sitting herethinking, you know it's.
It's hard enough for me to seepatients that that are not
involved in a clinical trial.
There is no, there is noprocedure truly that I have to
follow.
That's being dictated by asponsor, like you just mentioned
.
Um and I, I know what carethey're receiving because,
generally speaking, most of themare very stable.
(11:00):
But but for you, I wouldimagine, oh, I would imagine,
there is a substantial amount ofchart review that goes into
this, perhaps, and then and thenmaybe figuring out where that
patient is.
But what does that be like forone patient visit?
What is how much work is thatfor you?
Leigh (11:17):
Yeah, so a lot goes into it.
So before we start a trial wereceive the protocol and as
investigators it's our job toand generally where I work, it's
the sub-investigator thatreviews the protocol and is
charged with understanding itwell, so then we can then create
(11:39):
a sort of a template for therecruiters, for the recruiting
team to go and find the correctpatients.
So from the start, generally Iknow the protocol, you know
pretty well.
We'll teach the recruiters andthen patients, you know, start
to come in.
I will say that I know theprotocol.
You know by heart at first whenI'm, you know, learning about
(12:01):
it and going through it andteaching the recruiters.
But oftentimes, before it getsstarted, it can be, you know,
several weeks to months.
So generally I'll have to, youknow, refresh my memory when we
actually start the study.
And the good news is that it'svery easy to pull up the
protocol as needed to review and, you know, look at things
(12:22):
closely to ensure that we'refollowing it to a T and, you
know, always reviewing theinclusion and exclusion criteria
.
If there are certain lab valuesthat are exclusionary for
patients or if it meets thestopping criteria, it's called
for, you know, getting off of astudy drug, so there's a lot to
(12:42):
it, fortunately.
So there's a lot to it,fortunately.
Protocols are, you know, easilyaccessible and I'm constantly
going back and forth to thembecause obviously, with 40
studies going on, there's no wayto remember all the things all
the time.
But I've gotten very good atcontrol f and I can find
whatever I need in the protocolvery quickly, because they're
(13:03):
all similar and once you getused to reading protocols, you
know what you're looking forpretty quick.
Ashley (13:09):
That is so neat and I'm so glad you mentioned the
sub-investigator role again,because I did want to get back
to that, lee.
It sounds like, as a PA in thisfield, being a principal
investigator kind of in chargeand responsible for the conduct
of the trials, like youmentioned, it sounds like this
is obviously this is a reallyprestigious position in the
(13:33):
trial.
Is this common for well, numberone, is this common to see PAs
in clinical trial and clinicalresearch period?
And number two do you see a lotof PAs as principal
investigators?
Dr Anneke Vandenbroek.
Leigh (13:46):
Yeah.
So this is something that I wassomewhat interested in getting
into, becoming a principalinvestigator.
When I first started lookinginto clinical research it was
hard to find information on PAsas PIs Kids were getting older
(14:06):
teenage, young teenage years andI thought, if I was going to do
it, I wanted to do it soon,because I just didn't know how
long that feeling was going tolast.
But I wanted to go back andfurther my education and
honestly, I have college comingsoon for my girls.
Also, financially, it wassomething that I needed to do
now.
So I went back to get mydoctorate because I felt that
(14:27):
would give me a better chance toearn some study awards as a
principal investigator.
I think there definitely are PAsthat are PIs.
We are few and far between, butI think it will be happening
more, especially if we push forit.
I think we are certainly able.
We are well-educated and wemeet the criteria to be PAs
(14:50):
Certain studies certainly moreso than others.
There are studies that no doubtwould need specialists and we
would not likely be qualifiedfor, but I would say that a lot
of the studies that we do at oursite can be done very well by
PAs.
So I've been advocating to getinto that role a bit more, and
(15:11):
the studies that I've startedoff on being a principal
investigator are more likedevice studies, so things that
are like a one-time blood drawstudy and also questionnaire
studies, so when we try to findout more about patients'
experiences with differentthings of having a disease.
So you know, those kinds ofquestionnaire studies are
(15:36):
typically on the easier side andcan be done by a PI easily.
So it's nice to get my feet wetand I hope to continue to push
to get awarded more trials as aPI, to get awarded more trials
as a PI, and I'm very fortunatethat the research network that I
(15:56):
work for have supported mefully and the two full-time
physicians that I work with areextremely supportive as well,
which is wonderful.
Ashley (16:04):
It's great.
It's great to have support andthank you for trailblazing this
for PAs and other non-physicianclinicians PAs, nps, et cetera.
Can we talk a little bit abouta day in your life?
So so we've touched on this alittle bit.
Right, you have a lot ofpatients typically coming in on
a number of different trials.
What does it look like for you?
(16:24):
Are you at a computer most ofthe day?
Are you face-to-face withpatients?
Are you communicating with awhole bunch of other people of
the day?
Are you face-to-face withpatients?
Are you communicating with awhole bunch of other people
throughout the day?
What does your day today a dayin your life, if you will?
What does that look like?
Leigh (16:39):
Yeah, so my day usually starts off with reviewing labs
labs that came back in theprevious couple of days for
patients in either that arecurrently in a trial or who have
been screening and are wantingto be in the trial.
So these screening labs arereally important because they
may have exclusionary itemswithin the labs if they're
(17:01):
abnormal.
So I tend to do those first.
I like to get those done so Ican pass them on to our team so
they can see and make a plan forpatients.
And then during the day I willbe seeing patient visits
throughout the morning.
Throughout the morning for themost part, and it depends on
(17:22):
what the protocol calls for, sothey don't always need an
investigator to see the patient.
If it's just a follow-up andthere haven't been any adverse
events or any concerns, thenoftentimes a physical isn't even
required.
So a lot of our study visitsare performed only by the study
coordinator and the studycoordinator is the one who goes
(17:44):
in and takes care of the visit.
They document things, they takethe vitals and that type of
thing.
So there the study coordinatorsdo quite a bit, and even with
screening the study coordinatorswill take care of the informed
consent and things like that.
So they're very involved in thetrial.
But if there are any medicalquestions that come up, if
patients have questions aboutthe study or the investigational
(18:06):
product, the investigators arethe ones that would handle those
questions if it wasn't aquestion that the study
coordinator felt comfortabledoing or that kind of thing.
And then I've gotten moreinvolved in clinical operations
at our site.
We've had some staffing changesin the last year and so it's
necessitated that, but also Ithink it makes me a better
(18:28):
investigator to understand allthe site operations and how we
can become a sort of moreefficient site, provide really
good quality data to oursponsors.
So I've gotten more involved inprocesses in the lab and how
just how the lab is functioning,are we being efficient, are we
(18:48):
doing things to the best of ourability, and things like that.
So a lot of my time in themorning is just spent bopping
around to different departmentsjust to see if anybody needs
anything, how I can help.
There are always things thatare needing to be done, so
trying to help facilitatecommunication between
departments.
And we have wonderful teamswithin the office.
We also have researchassistants who do lots of things
(19:11):
, but they get the charts andthe lab kits prepped and things
like that and follow up labresults and do all sorts of
stuff, just always trying to besomeone who can help the other
teams if needed.
Because it's much.
Clinical research, at least atthe site level, is much
different than a clinic, becausethings are not the same every
day.
It's just not like you see,your you know schedule of
(19:35):
patients, however many that maybe.
Maybe you have to send one tothe emergency department every
couple weeks or depending onwhat field you're in, but here
things are just constantlychanging it's.
You can have a trial that'ssupposed to start tomorrow but
it doesn't start till next week,or they started early.
You got the green light tostart it sooner.
So things are.
There's constantly movingpieces that need to be followed
(19:55):
up on.
Ashley (19:58):
It's probably so exciting so exciting to walk
into work every day and know,generally speaking, what to
expect, because you know yourroles, but, at the same time,
also surprises, and probablyexciting surprises when it comes
to things like clinical trialsand the development of new
therapeutics and implementationof new devices, cutting edge of
medicine.
(20:18):
That's what you're waking up toevery single day, which is
really neat.
Leigh (20:22):
Yeah, it really is, and sometimes I really do have to
stand back and try to regainthat perspective because we
really are doing amazing things.
When you're seeing patientsthrough the different studies,
it doesn't necessarily alwaysfeel like it's like this could
be the next best thing, becauseyou're just going from the day
to day to day, but then once thestudy is completed and
(20:44):
sometimes they're years longstudies, so it's not like it
happens in a month when thestudy is completed you can go
wow, like we just put a lot ofpatients through this study,
hopefully study wide between allthe sites, that they were able,
the sponsor was able to gainenough good information and that
they can move forward with aproduct that can affect many in
(21:07):
a really great way.
Ashley (21:08):
I'm thinking about all of the advances that we've seen
in our lifetime and it's justincredible the amount of hard
work that has gone into so manyof these therapeutics and
devices.
So thank you for doing thathard work.
I want to talk about thepatients a little bit, and it's
a two-part idea.
You mentioned that therecruiter usually finds the
patients that might be eligiblefor this trial.
(21:30):
To your knowledge, what are thechallenges when you're trying
to recruit these patients for aclinical trial?
Leigh (21:39):
Oh yeah, there's a lot of challenges with recruiting.
So we have wonderful recruiters.
We have been around for about30 years certainly not with me
there.
I've been at this site for justover two years, but it's been
about 30 years.
So we have quite a database ofpatients with lots of different
diagnoses, which is helpful whenit comes to recruitment for
(22:00):
different studies.
For example, if we have amigraine study, we can just go
right to that patient base andoftentimes we're given a
recruitment allotment, amarketing budget, to recruit for
different studies, and you'dthink that might be enough, but
unfortunately sometimes it's notand recruitment can be a real
problem, especially forprotocols that are very specific
(22:23):
.
So, for example, you may have aprotocol that wants somebody
with this is just me throwing itout there but they might want
somebody with establishedcardiovascular disease, diabetes
and hypertension or whatever,and it can be very, it can be
difficult.
It can be like trying to find aneedle in a haystack sometimes
these patients.
(22:43):
And then does the patient wantto be in the trial?
Are they on exclusionarymedications?
Do they have other diagnosesthat prohibit them from being a
candidate for being in the trial?
So it can be a challenge.
We certainly get a lot ofpeople that are interested, but
finding people that meet all thedifferent criteria can be a
real challenge in some studies.
Ashley (23:02):
Yeah, I can't imagine.
I thank God for the recruitersright.
Yes, they're amazing.
Leigh (23:09):
Love them.
Ashley (23:11):
Now the second part of that question is you mentioned
exclusionary criteria, or atsome point perhaps a patient has
to be pulled off of a trial.
Is that something you have totell the patient?
Is that your job to do that,and if so, is that a hard
conversation?
I'm thinking of when I do abiopsy on a patient and I have
(23:31):
to tell the patient thatunfortunately, they have a type
of cancer.
That's a very hard conversationfor me a lot of times.
When you have to pull a patientoff of one of these trials
because of an exclusionarycriterium, is that a hard, sad
conversation?
Leigh (23:51):
Yeah, so I'll just go.
I'll go back to why patientsmight be in a trial.
So patients come to us or areinterested in being in trials
for a few different reasons.
One might be because they'realtruistic, they just want to do
good, they want to make adifference, and so we have.
That's one side of it.
(24:12):
The other side of it is thatthey may have a disease that
they can't get a particulartreatment for unless they
participate in a trial, and thisis a good opportunity for them
to possibly do so free of charge, along with diagnostic testing
and things like that.
So that could be another reason.
And then I would say, like thethird biggest reason might be
financial gain.
(24:33):
So those three things are whypeople might do it, and it may
be some combination of the three.
Right, you can't blame people.
It's nice to get paid for yourtime and effort.
Trials they require work.
We patients have to come inseveral times during the trial
at least.
Sometimes we have to repeat labwork.
If something happened with thelabs or if they had a value that
(24:53):
was not acceptable, we mighthave to repeat it.
So it is a commitment, and weunderstand that.
When I have to explain tosomeone that we have to end
their participation in a trialor if I have to let them know
that they don't meet criteria tobe in the trial.
It can be difficult.
My first, the first thing Ialways start with, especially if
(25:13):
it's for a medical exclusion,is that, say, patient safety
comes first.
So if, for whatever reason,they're excluded because of some
medical condition or a findingduring the screening that makes
it so that they're not acandidate anymore, I tell them
exactly that you don't meet thecriteria because X, y and Z and
this is a clinical trial and youmay be affected negatively if
(25:37):
we proceed based on whatever thefinding is.
And usually if you go thatroute and explain that it's just
about keeping patients safe,that's the number one priority.
Yes, we're trying to do research, find out all sorts of cool new
things, but patient safety isnumber one.
And then most times people aregreat about it and they
understand and they'll just wantto get involved in another
(26:00):
trial soon, especially ifthey're doing it because they've
done many before.
So people are generallyunderstanding.
Especially they're appreciativeif we are cautious and it's a
safety concern.
They're understanding If it'ssomebody that might have come in
more for the financial gain ofbeing in a research study.
It can be a little trickier buthonestly we don't really have a
(26:24):
big problem People if they didit because they have an
underlying condition that theywere hoping to get treatment for
, of course it's verydisappointing for them, but I
think you know people thatparticipate in clinical research
do realize that whatever isbeing studied is for a certain
population, so generally it'snot a huge problem.
Ashley (26:48):
That was absolute gold and I am so glad that you broke
that down so well.
Thank you.
I feel like that was just likea mini TED Talk.
Patient safety coming first andpatient safety being most
important is huge, and I am soglad that you mentioned that,
because I do think that thereare a lot of misconceptions and
a lot of you know, maybe peoplehaving the wrong idea of what
(27:11):
clinical trials are for and ourcompany's just trying to push
their drugs, or are theyactually looking out for the
betterment of humans?
And so the fact that youhighlighted that it just it
brings me such joy and it makesme so happy, and the fact that
your patients understand thattoo.
Really, it sounds like justgoing into it, and perhaps,
again, we should just applaudthe recruiters for how well of a
(27:32):
job that they do, but tounderstand that these trials are
important not just for them,but for the human race, for all
of us, to develop thesefantastic therapeutics and these
fantastic devices.
So very well done, keeping itpatient centric.
I think that's important and soamazing.
I mentioned misconceptions.
That's always a fun question.
(27:53):
In your opinion, what do youthink the biggest misconception
is about clinical research rightnow?
Leigh (28:01):
Something that I have heard in the past are that you
know you just want to use us asguinea pigs, and I think that
certainly a lot of peopleprobably feel that way.
If I just break down clinicalresearch a bit more and talk
about the different phases oftrials, that can be somewhat
(28:22):
eye-opening.
So, for example, we do phaseone through phase four clinical
trials, and a phase one clinicaltrial is the beginning of it.
Right, that's when you'rereally looking.
If you have an investigationalproduct that is being evaluated,
safety comes first, as Imentioned.
So a phase one trial is onewhere the focus is safety.
(28:45):
It's very small numbers ofparticipants and you are just
looking for any signals for itbeing unsafe or anything like
that, and it's very closelymonitored.
So it's not like they're justthrowing it out there for
hundreds and thousands ofpatients.
The numbers are very small.
So that's the first step andthen, as you move through the
(29:06):
phases, the number of patientsgets larger.
You start looking more at theefficacy and the dosing and
things like that, but safetyremains a hallmark throughout.
All these things are monitoredvery closely Lab studies for
some procedures, ekgs,echocardiograms, other scans,
depending on what is beingstudied, the one thing we don't
(29:28):
study where I work is cancer andcancer treatments.
But in general we're looking atall the things and trying to
monitor for any safety signalfrom whatever product it is,
from a vaccine to a therapeuticmedication.
That remains at the forefrontand I would say that these
things are studied ad nauseum.
We're constantly looking atdifferent things so to keep
(29:52):
everybody safe.
Ashley (29:53):
I want to close how we usually open, which is, tell me
about your journey, to how yougot here.
At some point, you knew youwanted to be a PA.
I'd love to hear that.
And then what?
What shifted?
At what point did you say youknow what?
Being a PA is super cool, butthere's something more here and
I'm going to go seek it out.
Leigh (30:13):
Yeah.
So growing up I for some reasonI don't know I think sometimes
you just have this feeling thatyou want to be something.
So from a young age I alwayswanted to be a pediatrician.
I loved kids when I was young,I loved babysitting, I wanted to
be a mom all things kids.
But then when I got to college,I started to rethink things,
(30:35):
and I was.
I certainly was like a sciencebackground biology and then I
started thinking more like, well, what would be a great career
for a woman?
My stepdad was a rheumatologistand so I saw all the hours he
put into things and he, thoughhe absolutely loved his job.
I think he's tried to steer mein a different direction, which
I do really appreciate now.
Not that I would, I don't thinkI.
(30:56):
I think I would have likedbeing a physician, but I had
other goals too.
I mentioned wanting to be a mom.
That was something that I knewI wanted to do sooner than later
.
So he had said what about beinga dentist?
So then I started to look intothat and then I did some
shadowing of dentists andrealized that wasn't going to be
for me.
So then I looked into what elseI wanted to do and he had a
(31:20):
great friend that was a PA.
So I spent some time with him.
He was like a very autonomous,loved his job.
He was a community guy.
He had been around for manydecades and I'm like this would
be perfect.
So I decided to go to PA school.
I went to school inPhiladelphia, had a wonderful I
feel like I had a really greateducation there.
I came out feeling ready to dothis and I got into
(31:43):
cardiothoracic surgery when Ifirst became a PA in 2006.
Then I moved on.
I really loved the intensivecare or critical care piece of
T-surgery, so we moved around alittle bit before we settled
down.
I worked in critical care forjust about a decade or so and
then I realized that when thekids were young, that I needed
(32:04):
something more stable.
So I went into cardiology forabout eight years or so, which
was definitely my favorite.
I just absolutely lovecardiology.
But I started to feel like Iwanted to do more and so, after
doing the same thing, what seemsevery day, even though I love
the patients and love being ableto help them I just I felt like
(32:25):
there was more that I could do.
I think the pandemic reallyturned my attention towards
clinical research because, ofcourse, we were trying to roll
out a vaccine quickly and I wasjust curious about the process.
I started doing a lot ofresearch and reading a lot of
scholarly articles during thattime, and so that's what made me
start to look into this more,and I found a local research
(32:47):
site and, though they didn'thave a position available, I
reached out and so, having donethat, when a job became
available, they contacted me,and so that's how I started
there Two years ago.
I was very, very nervous totake the plunge, but I'm
(33:07):
grateful that I did, becausethere's just so much more out
there.
I think if I had stayed incardiology and I might not have
had the energy to go on to getmy doctorate of medical science,
which was a goal of mine, andI'm grateful that this job had
gave me that energy, thatwork-life balance to be able to
(33:28):
go out and do that.
With working full-time andhaving a family and teenage kids
, that you know, all the taxiingaround to different events.
It's been really great and Ifeel very fortunate that I was
called to do this, and I'mexcited about the future for
sure.
Ashley (33:43):
I feel very fortunate that I was called to do this and
I'm excited about the futurefor sure.
What a fantastic career journeyfrom cardiothoracic surgery to
critical care to cardiology.
You've seen patients at theirworst and you've cared for them
then and now, doing what you'redoing, you have your doctorate
of medical science.
You know, I, I just, you know,I just I loved what you just
said about realizing we PAs, wework clinicians, generally
(34:09):
speaking, we work in a fantasticfield and yet there's always
that desire of wanting to domore and there was more that you
can do.
And I think that is so amazingas a PA these days is that the
doors are really opening forthis profession, for PAs and for
MPs, and and we're being,generally speaking, I think
(34:29):
we're being very welcomed by the, by the healthcare community,
into these roles and it's sointeresting.
I'm so glad that you said thatabout the pandemic.
Covid comes up in everyconversation.
I absolutely never include iton the question list and it
always, always, always comes up,and I think yours is an
interesting take on thecoronavirus vaccine.
(34:50):
We have to admit that theprocess was interesting and you
found that interest and youchased it and look what you're
doing now.
Because of that.
It is just.
It is so cool.
I'm just so amazed by you andwhat you're doing and I applaud
you.
Let's talk to our pre-healthstudents.
What skills should they focuson developing if they're looking
(35:12):
towards a career eventually inclinical research?
Leigh (35:18):
Yeah, I think it's important to get the sciences in
and things like that, like younormally would with any
pre-health type of role.
But for research, you can lookinto trainings like CITI is a
type of training and they havedifferent courses in good
clinical practice or it's calledGCP.
(35:39):
So a good clinical practice orGCP is something that you'd have
to get trained in, and theother thing is HSP, which is
human subjects protection, andthose things are not.
If there was a PA who wasinterested in being a
sub-investigator or somethingit's not something you'd have to
go out and do before, but ifyou had that, if you had done
that training, that would looklike you were motivated, I think
(36:01):
, for a potential employer or ifyou were looking to get into
this type of work.
If you have done any of thatresearch, it's very important.
All, like I mentioned, all thisreally focuses around safety of
patients and keeping that atthe forefront really of all the
work that we do.
Ashley (36:17):
That is so great, Lee.
Thank you so much for joiningus on Shadow Me Next.
It has been an absolutepleasure.
Thank you so much for joiningus on Shadow Me Next.
It has been an absolutepleasure.
Leigh (36:25):
Thank you so much, ashley, I really appreciate it.
Ashley (36:28):
Thank you so very much for listening to this episode of
Shadow Me Next.
If you liked this episode or ifyou think it could be useful
for a friend, please subscribeand invite them to join us next
Monday, as always.
If you have any questions, letme know on Facebook or Instagram
Access.
You want stories you needquestions?
Let me know on Facebook orInstagram Access.
You want stories you need?
You're always invited to shadowme next.
Hello and welcome to Shadow Me Next, a podcast where
I take you into and behind thescenes of the medical world to
provide you with a deeperunderstanding of the human side
of medicine.
I'm Ashley, a physicianassistant, medical editor,
clinical preceptor and thecreator of Shadow Me Next.
It is my pleasure to introduceyou to incredible members of the
(00:22):
healthcare field and uncovertheir unique stories, the joys
and challenges they face andwhat drives them in their
careers.
It's access you want andstories you need, whether you're
a pre-health student or simplycurious about the healthcare
field.
I invite you to join me as wetake a conversational and
personal look into the lives andminds of leaders in medicine.
(00:43):
I don't want you to miss asingle one of these
conversations, so make sure thatyou subscribe to this podcast,
which will automatically notifyyou when new episodes are
dropped, and follow us onInstagram and Facebook at Shadow
Me Next, where we will reviewhighlights from this
conversation and where I'll giveyou sneak previews of our
upcoming guests.
I'm thrilled to introducetoday's guest, lee Shermer, a
(01:07):
physician assistant and doctorof medical science, who is also
a trailblazer in the world ofclinical research and a true
advocate for PAs and roles youmight not expect.
With over 18 years of experiencein healthcare.
Lee has worked acrosscardiology, critical care and
cardiothoracic surgery, but it'sher current role as a principal
(01:29):
investigator andsub-investigator in clinical
research that sets her apart.
Lee's journey into clinicalresearch was sparked by her
curiosity during the pandemic,especially around the rapid
development of vaccines.
Now she's leading trials indiverse fields, from psychiatric
studies to cardiac research,ensuring patient safety and
(01:50):
pushing the boundaries ofmedical advancements.
She shares how being a PA inclinical research is anything
but behind the scenes work.
It's hands-on, patient-focusedand absolutely vital to the
development of new therapeuticsand devices.
Focused and absolutely vital tothe development of new
therapeutics and devices.
In this episode, leigh takes usbehind the curtain of clinical
(02:12):
trials, explaining thedifference between principal
investigators andsub-investigators, how patients
are selected and sometimesrejected from clinical trials,
the importance of safety inclinical research and how she's
helping to reshape the role ofPAs in this growing field.
If you have ever wondered aboutthe cutting edge of medicine
and the real impact of clinicalresearch, this is an episode you
(02:34):
won't want to miss.
Please keep in mind that thecontent of this podcast is
intended for informational andentertainment purposes only and
should not be considered asprofessional medical advice.
The views and opinionsexpressed in this podcast are
those of the host and guests anddo not necessarily reflect the
official policy or position ofany other agency, organization,
(02:56):
employer or company.
This is Shadow Me Next withLeigh Shermer.
Leigh, thank you so much forjoining us on shadow me next
today.
I am thrilled that you are hereand you have a very unique role
in medicine, and so the factthat we are talking about this
is just something of my dreams.
So thank you so much for beinghere and joining us.
(03:16):
Yes, thank you so much forhaving me, ashley.
So, lee, tell me, tell me whatyour title is, and then tell me
what you do on the day-to-daywhen you come to work.
You are a PA, but your lifelooks very different than my
life.
Leigh (03:32):
Yes, so I work in clinical research.
I am an investigator, generallya sub-investigator, but I have
been on some studies where I'mthe principal investigator,
which I'm sure we'll get into ina little bit.
But basically clinical researchis a field of medicine where we
(03:53):
do the beginning stages ofresearch so that we can help
take care of people.
And you know, in clinicalmedicine we're used to
prescribing medications after wemake diagnoses and things like
that, and this is like thebeginning work and we, you know,
are sort of behind the scenesin a different area of medicine
(04:14):
where we are doing trials fordifferent therapies, whether it
be vaccines or therapeutics, soyour typical medications that
might be prescribedantihypertensives or
therapeutics.
So your typical medicationsthat might be prescribed
antihypertensives, statinmedications and all sorts of fun
other things you know, like theweight loss medications, which
are really a hot thing right now.
Ashley (04:34):
That's fantastic.
So, investigator, tell us moreabout this.
You mentioned two differenttypes.
What are the roles that both ofthose play?
Keep in mind that there's moreinterview prep, such as mock
interviews and personalstatement review, over on
shadowmenextcom.
There you'll find amazingresources to help you as you
prepare to answer your ownquality questions.
Now, lee and I did not discussa quality question, but from our
(04:58):
conversation, there was onetopic that would make a
fantastic interview question howdoes clinical research improve
healthcare and what role do PAsplay in advancing these
improvements?
This is going to be what westart to see in the future, and
being able to answer thisquestion during an interview
(05:18):
will set you apart from many ofthe other applicants.
Leigh (05:22):
Yeah, so an investigator is like a medical practitioner
of some sort who is seeingpatients and determining their
eligibility and safety duringtrials at the beginning, before
they even get into a trial perse.
Generally the role of aprincipal investigator has been
(05:42):
that of a medical doctor or aPhD or a dentist, for example.
There are certainly others aswell, but it's generally been a
medical doctor, when you talkabout clinical research, for
many of the trials that we do,and they are basically in charge
(06:03):
of, responsible for the conductof the trial, and everyone that
participates in the trial froma site standpoint or from the
research site standpoint isunder that principal
investigator's sort ofdelegation.
So they're delegated by theprincipal investigator to
participate in the trial becausethey have the qualifications to
(06:26):
do so.
The sub-investigator role,which is generally something
that is more suited to PAs, nps,but certainly also physicians
and others, can be alsodelegated to the
sub-investigator role.
It's generally somebody withsome sort of medical degree can
(06:48):
basically do all the same thingsthat the principal investigator
would do, but they're delegatedunder the principal
investigator to do those thingsbecause they have the medical
qualifications to do so.
So they would still do, youknow, taking history and
physicals, ensuring thatpatients meet the criteria to be
in the trial, they're safe tobe in the trial and all those
(07:10):
type of things.
So it's exciting.
There's a lot to the role, theinvestigator role.
I certainly didn't knowanything about it until I
started to research, you know,getting into clinical research
you know, getting into clinicalresearch.
Ashley (07:28):
It is fascinating to me, and here I am thinking in
clinical research you're justyou're sitting behind a desk all
day and you know running,running tests and and messing
with computers and equipment,and it turns out there's there's
an entire clinical side to this, right.
I mean, it is still directpatient care, from what it
sounds like.
Leigh (07:43):
Yes, yes.
So the nice thing aboutclinical research is it's not
your typical kind of chemistrybehind the bench doing
laboratory studies.
This is a whole different field, but this remains clinical, so
that's the piece of it that Ireally love.
So, generally, these are eitherI work at the site level, so I
(08:03):
work at a standalone clinicalresearch site Actually, we're
part of a network now, which iscool, but I work at a standalone
site and other sites might beunder.
You know a university and thatyou have different departments
within the university that runtheir own research, but I
actually work at a clinicalresearch site.
It's been around for about 30years.
(08:24):
We do all sorts of differentresearch as I mentioned vaccines
and therapeutics but I get tosee patients every day, which is
really great.
So we see patients.
When they come to us and theywant to get in a trial, we
determine their eligibility todo so and then see them
throughout the trial atdifferent visits as needed, and
(08:46):
basically everything is off of aprotocol that has been sent to
us or has been created bycertain sponsors, and when we
say sponsors, those aregenerally pharmaceutical
companies or device companiesthat make up protocols and we
are in charge of following themto a T.
So it's nice we see all sortsof different things.
(09:08):
The protocols are varied,especially in you know how
complicated they are, but itcertainly gets me thinking.
Every day and no two days arethe same the type of patients
that I see run the gamut betweenpsychiatric style, different
studies, cardiac studies, gistudies, neuro studies.
(09:29):
So it's really I see see a lot.
Ashley (09:33):
Now is that.
Would that all be like in thespan of one day?
Do you have different patientscoming in for different clinical
studies throughout the entireday, or do you have like Monday
is your psychiatric study andTuesday is your cardiovascular
study, and so on and so forth?
Leigh (09:48):
Yes, so at our site we have about 40 active studies
right now, so it's a lot.
We are very busy, yeah, andmost days are mixed in, so you
have patients coming in from allthe different studies, which is
really pretty neat.
The only time that we wouldgenerally have a full day of the
same patient would be if wehave, like, if we're enrolling a
(10:11):
high, high volume vaccine studyor something, and then you
would see patients for the samestudy all day.
That's just the way we.
We would do it.
We call it like a bulk daywhere we would just see the same
, just to make it easier.
So the staff you know sort ofknow what we're doing and kind
of go from there.
But most days are very varied,are varied, and so that works
(10:35):
out well and keeps things fresh.
Ashley (10:39):
How do you keep all that straight?
I mean, I'm just sitting herethinking, you know it's.
It's hard enough for me to seepatients that that are not
involved in a clinical trial.
There is no, there is noprocedure truly that I have to
follow.
That's being dictated by asponsor, like you just mentioned
.
Um and I, I know what carethey're receiving because,
generally speaking, most of themare very stable.
(11:00):
But but for you, I wouldimagine, oh, I would imagine,
there is a substantial amount ofchart review that goes into
this, perhaps, and then and thenmaybe figuring out where that
patient is.
But what does that be like forone patient visit?
What is how much work is thatfor you?
Leigh (11:17):
Yeah, so a lot goes into it.
So before we start a trial wereceive the protocol and as
investigators it's our job toand generally where I work, it's
the sub-investigator thatreviews the protocol and is
charged with understanding itwell, so then we can then create
(11:39):
a sort of a template for therecruiters, for the recruiting
team to go and find the correctpatients.
So from the start, generally Iknow the protocol, you know
pretty well.
We'll teach the recruiters andthen patients, you know, start
to come in.
I will say that I know theprotocol.
You know by heart at first whenI'm, you know, learning about
(12:01):
it and going through it andteaching the recruiters.
But oftentimes, before it getsstarted, it can be, you know,
several weeks to months.
So generally I'll have to, youknow, refresh my memory when we
actually start the study.
And the good news is that it'svery easy to pull up the
protocol as needed to review and, you know, look at things
(12:22):
closely to ensure that we'refollowing it to a T and, you
know, always reviewing theinclusion and exclusion criteria
.
If there are certain lab valuesthat are exclusionary for
patients or if it meets thestopping criteria, it's called
for, you know, getting off of astudy drug, so there's a lot to
(12:42):
it, fortunately.
So there's a lot to it,fortunately.
Protocols are, you know, easilyaccessible and I'm constantly
going back and forth to thembecause obviously, with 40
studies going on, there's no wayto remember all the things all
the time.
But I've gotten very good atcontrol f and I can find
whatever I need in the protocolvery quickly, because they're
(13:03):
all similar and once you getused to reading protocols, you
know what you're looking forpretty quick.
Ashley (13:09):
That is so neat and I'm so glad you mentioned the
sub-investigator role again,because I did want to get back
to that, lee.
It sounds like, as a PA in thisfield, being a principal
investigator kind of in chargeand responsible for the conduct
of the trials, like youmentioned, it sounds like this
is obviously this is a reallyprestigious position in the
(13:33):
trial.
Is this common for well, numberone, is this common to see PAs
in clinical trial and clinicalresearch period?
And number two do you see a lotof PAs as principal
investigators?
Dr Anneke Vandenbroek.
Leigh (13:46):
Yeah.
So this is something that I wassomewhat interested in getting
into, becoming a principalinvestigator.
When I first started lookinginto clinical research it was
hard to find information on PAsas PIs Kids were getting older
(14:06):
teenage, young teenage years andI thought, if I was going to do
it, I wanted to do it soon,because I just didn't know how
long that feeling was going tolast.
But I wanted to go back andfurther my education and
honestly, I have college comingsoon for my girls.
Also, financially, it wassomething that I needed to do
now.
So I went back to get mydoctorate because I felt that
(14:27):
would give me a better chance toearn some study awards as a
principal investigator.
I think there definitely are PAsthat are PIs.
We are few and far between, butI think it will be happening
more, especially if we push forit.
I think we are certainly able.
We are well-educated and wemeet the criteria to be PAs
(14:50):
Certain studies certainly moreso than others.
There are studies that no doubtwould need specialists and we
would not likely be qualifiedfor, but I would say that a lot
of the studies that we do at oursite can be done very well by
PAs.
So I've been advocating to getinto that role a bit more, and
(15:11):
the studies that I've startedoff on being a principal
investigator are more likedevice studies, so things that
are like a one-time blood drawstudy and also questionnaire
studies, so when we try to findout more about patients'
experiences with differentthings of having a disease.
So you know, those kinds ofquestionnaire studies are
(15:36):
typically on the easier side andcan be done by a PI easily.
So it's nice to get my feet wetand I hope to continue to push
to get awarded more trials as aPI, to get awarded more trials
as a PI, and I'm very fortunatethat the research network that I
(15:56):
work for have supported mefully and the two full-time
physicians that I work with areextremely supportive as well,
which is wonderful.
Ashley (16:04):
It's great.
It's great to have support andthank you for trailblazing this
for PAs and other non-physicianclinicians PAs, nps, et cetera.
Can we talk a little bit abouta day in your life?
So so we've touched on this alittle bit.
Right, you have a lot ofpatients typically coming in on
a number of different trials.
What does it look like for you?
(16:24):
Are you at a computer most ofthe day?
Are you face-to-face withpatients?
Are you communicating with awhole bunch of other people of
the day?
Are you face-to-face withpatients?
Are you communicating with awhole bunch of other people
throughout the day?
What does your day today a dayin your life, if you will?
What does that look like?
Leigh (16:39):
Yeah, so my day usually starts off with reviewing labs
labs that came back in theprevious couple of days for
patients in either that arecurrently in a trial or who have
been screening and are wantingto be in the trial.
So these screening labs arereally important because they
may have exclusionary itemswithin the labs if they're
(17:01):
abnormal.
So I tend to do those first.
I like to get those done so Ican pass them on to our team so
they can see and make a plan forpatients.
And then during the day I willbe seeing patient visits
throughout the morning.
Throughout the morning for themost part, and it depends on
(17:22):
what the protocol calls for, sothey don't always need an
investigator to see the patient.
If it's just a follow-up andthere haven't been any adverse
events or any concerns, thenoftentimes a physical isn't even
required.
So a lot of our study visitsare performed only by the study
coordinator and the studycoordinator is the one who goes
(17:44):
in and takes care of the visit.
They document things, they takethe vitals and that type of
thing.
So there the study coordinatorsdo quite a bit, and even with
screening the study coordinatorswill take care of the informed
consent and things like that.
So they're very involved in thetrial.
But if there are any medicalquestions that come up, if
patients have questions aboutthe study or the investigational
(18:06):
product, the investigators arethe ones that would handle those
questions if it wasn't aquestion that the study
coordinator felt comfortabledoing or that kind of thing.
And then I've gotten moreinvolved in clinical operations
at our site.
We've had some staffing changesin the last year and so it's
necessitated that, but also Ithink it makes me a better
(18:28):
investigator to understand allthe site operations and how we
can become a sort of moreefficient site, provide really
good quality data to oursponsors.
So I've gotten more involved inprocesses in the lab and how
just how the lab is functioning,are we being efficient, are we
(18:48):
doing things to the best of ourability, and things like that.
So a lot of my time in themorning is just spent bopping
around to different departmentsjust to see if anybody needs
anything, how I can help.
There are always things thatare needing to be done, so
trying to help facilitatecommunication between
departments.
And we have wonderful teamswithin the office.
We also have researchassistants who do lots of things
(19:11):
, but they get the charts andthe lab kits prepped and things
like that and follow up labresults and do all sorts of
stuff, just always trying to besomeone who can help the other
teams if needed.
Because it's much.
Clinical research, at least atthe site level, is much
different than a clinic, becausethings are not the same every
day.
It's just not like you see,your you know schedule of
(19:35):
patients, however many that maybe.
Maybe you have to send one tothe emergency department every
couple weeks or depending onwhat field you're in, but here
things are just constantlychanging it's.
You can have a trial that'ssupposed to start tomorrow but
it doesn't start till next week,or they started early.
You got the green light tostart it sooner.
So things are.
There's constantly movingpieces that need to be followed
(19:55):
up on.
Ashley (19:58):
It's probably so exciting so exciting to walk
into work every day and know,generally speaking, what to
expect, because you know yourroles, but, at the same time,
also surprises, and probablyexciting surprises when it comes
to things like clinical trialsand the development of new
therapeutics and implementationof new devices, cutting edge of
medicine.
(20:18):
That's what you're waking up toevery single day, which is
really neat.
Leigh (20:22):
Yeah, it really is, and sometimes I really do have to
stand back and try to regainthat perspective because we
really are doing amazing things.
When you're seeing patientsthrough the different studies,
it doesn't necessarily alwaysfeel like it's like this could
be the next best thing, becauseyou're just going from the day
to day to day, but then once thestudy is completed and
(20:44):
sometimes they're years longstudies, so it's not like it
happens in a month when thestudy is completed you can go
wow, like we just put a lot ofpatients through this study,
hopefully study wide between allthe sites, that they were able,
the sponsor was able to gainenough good information and that
they can move forward with aproduct that can affect many in
(21:07):
a really great way.
Ashley (21:08):
I'm thinking about all of the advances that we've seen
in our lifetime and it's justincredible the amount of hard
work that has gone into so manyof these therapeutics and
devices.
So thank you for doing thathard work.
I want to talk about thepatients a little bit, and it's
a two-part idea.
You mentioned that therecruiter usually finds the
patients that might be eligiblefor this trial.
(21:30):
To your knowledge, what are thechallenges when you're trying
to recruit these patients for aclinical trial?
Leigh (21:39):
Oh yeah, there's a lot of challenges with recruiting.
So we have wonderful recruiters.
We have been around for about30 years certainly not with me
there.
I've been at this site for justover two years, but it's been
about 30 years.
So we have quite a database ofpatients with lots of different
diagnoses, which is helpful whenit comes to recruitment for
(22:00):
different studies.
For example, if we have amigraine study, we can just go
right to that patient base andoftentimes we're given a
recruitment allotment, amarketing budget, to recruit for
different studies, and you'dthink that might be enough, but
unfortunately sometimes it's notand recruitment can be a real
problem, especially forprotocols that are very specific
(22:23):
.
So, for example, you may have aprotocol that wants somebody
with this is just me throwing itout there but they might want
somebody with establishedcardiovascular disease, diabetes
and hypertension or whatever,and it can be very, it can be
difficult.
It can be like trying to find aneedle in a haystack sometimes
these patients.
(22:43):
And then does the patient wantto be in the trial?
Are they on exclusionarymedications?
Do they have other diagnosesthat prohibit them from being a
candidate for being in the trial?
So it can be a challenge.
We certainly get a lot ofpeople that are interested, but
finding people that meet all thedifferent criteria can be a
real challenge in some studies.
Ashley (23:02):
Yeah, I can't imagine.
I thank God for the recruitersright.
Yes, they're amazing.
Leigh (23:09):
Love them.
Ashley (23:11):
Now the second part of that question is you mentioned
exclusionary criteria, or atsome point perhaps a patient has
to be pulled off of a trial.
Is that something you have totell the patient?
Is that your job to do that,and if so, is that a hard
conversation?
I'm thinking of when I do abiopsy on a patient and I have
(23:31):
to tell the patient thatunfortunately, they have a type
of cancer.
That's a very hard conversationfor me a lot of times.
When you have to pull a patientoff of one of these trials
because of an exclusionarycriterium, is that a hard, sad
conversation?
Leigh (23:51):
Yeah, so I'll just go.
I'll go back to why patientsmight be in a trial.
So patients come to us or areinterested in being in trials
for a few different reasons.
One might be because they'realtruistic, they just want to do
good, they want to make adifference, and so we have.
That's one side of it.
(24:12):
The other side of it is thatthey may have a disease that
they can't get a particulartreatment for unless they
participate in a trial, and thisis a good opportunity for them
to possibly do so free of charge, along with diagnostic testing
and things like that.
So that could be another reason.
And then I would say, like thethird biggest reason might be
financial gain.
(24:33):
So those three things are whypeople might do it, and it may
be some combination of the three.
Right, you can't blame people.
It's nice to get paid for yourtime and effort.
Trials they require work.
We patients have to come inseveral times during the trial
at least.
Sometimes we have to repeat labwork.
If something happened with thelabs or if they had a value that
(24:53):
was not acceptable, we mighthave to repeat it.
So it is a commitment, and weunderstand that.
When I have to explain tosomeone that we have to end
their participation in a trialor if I have to let them know
that they don't meet criteria tobe in the trial.
It can be difficult.
My first, the first thing Ialways start with, especially if
(25:13):
it's for a medical exclusion,is that, say, patient safety
comes first.
So if, for whatever reason,they're excluded because of some
medical condition or a findingduring the screening that makes
it so that they're not acandidate anymore, I tell them
exactly that you don't meet thecriteria because X, y and Z and
this is a clinical trial and youmay be affected negatively if
(25:37):
we proceed based on whatever thefinding is.
And usually if you go thatroute and explain that it's just
about keeping patients safe,that's the number one priority.
Yes, we're trying to do research, find out all sorts of cool new
things, but patient safety isnumber one.
And then most times people aregreat about it and they
understand and they'll just wantto get involved in another
(26:00):
trial soon, especially ifthey're doing it because they've
done many before.
So people are generallyunderstanding.
Especially they're appreciativeif we are cautious and it's a
safety concern.
They're understanding If it'ssomebody that might have come in
more for the financial gain ofbeing in a research study.
It can be a little trickier buthonestly we don't really have a
(26:24):
big problem People if they didit because they have an
underlying condition that theywere hoping to get treatment for
, of course it's verydisappointing for them, but I
think you know people thatparticipate in clinical research
do realize that whatever isbeing studied is for a certain
population, so generally it'snot a huge problem.
Ashley (26:48):
That was absolute gold and I am so glad that you broke
that down so well.
Thank you.
I feel like that was just likea mini TED Talk.
Patient safety coming first andpatient safety being most
important is huge, and I am soglad that you mentioned that,
because I do think that thereare a lot of misconceptions and
a lot of you know, maybe peoplehaving the wrong idea of what
(27:11):
clinical trials are for and ourcompany's just trying to push
their drugs, or are theyactually looking out for the
betterment of humans?
And so the fact that youhighlighted that it just it
brings me such joy and it makesme so happy, and the fact that
your patients understand thattoo.
Really, it sounds like justgoing into it, and perhaps,
again, we should just applaudthe recruiters for how well of a
(27:32):
job that they do, but tounderstand that these trials are
important not just for them,but for the human race, for all
of us, to develop thesefantastic therapeutics and these
fantastic devices.
So very well done, keeping itpatient centric.
I think that's important and soamazing.
I mentioned misconceptions.
That's always a fun question.
(27:53):
In your opinion, what do youthink the biggest misconception
is about clinical research rightnow?
Leigh (28:01):
Something that I have heard in the past are that you
know you just want to use us asguinea pigs, and I think that
certainly a lot of peopleprobably feel that way.
If I just break down clinicalresearch a bit more and talk
about the different phases oftrials, that can be somewhat
(28:22):
eye-opening.
So, for example, we do phaseone through phase four clinical
trials, and a phase one clinicaltrial is the beginning of it.
Right, that's when you'rereally looking.
If you have an investigationalproduct that is being evaluated,
safety comes first, as Imentioned.
So a phase one trial is onewhere the focus is safety.
(28:45):
It's very small numbers ofparticipants and you are just
looking for any signals for itbeing unsafe or anything like
that, and it's very closelymonitored.
So it's not like they're justthrowing it out there for
hundreds and thousands ofpatients.
The numbers are very small.
So that's the first step andthen, as you move through the
(29:06):
phases, the number of patientsgets larger.
You start looking more at theefficacy and the dosing and
things like that, but safetyremains a hallmark throughout.
All these things are monitoredvery closely Lab studies for
some procedures, ekgs,echocardiograms, other scans,
depending on what is beingstudied, the one thing we don't
(29:28):
study where I work is cancer andcancer treatments.
But in general we're looking atall the things and trying to
monitor for any safety signalfrom whatever product it is,
from a vaccine to a therapeuticmedication.
That remains at the forefrontand I would say that these
things are studied ad nauseum.
We're constantly looking atdifferent things so to keep
(29:52):
everybody safe.
Ashley (29:53):
I want to close how we usually open, which is, tell me
about your journey, to how yougot here.
At some point, you knew youwanted to be a PA.
I'd love to hear that.
And then what?
What shifted?
At what point did you say youknow what?
Being a PA is super cool, butthere's something more here and
I'm going to go seek it out.
Leigh (30:13):
Yeah.
So growing up I for some reasonI don't know I think sometimes
you just have this feeling thatyou want to be something.
So from a young age I alwayswanted to be a pediatrician.
I loved kids when I was young,I loved babysitting, I wanted to
be a mom all things kids.
But then when I got to college,I started to rethink things,
(30:35):
and I was.
I certainly was like a sciencebackground biology and then I
started thinking more like, well, what would be a great career
for a woman?
My stepdad was a rheumatologistand so I saw all the hours he
put into things and he, thoughhe absolutely loved his job.
I think he's tried to steer mein a different direction, which
I do really appreciate now.
Not that I would, I don't thinkI.
(30:56):
I think I would have likedbeing a physician, but I had
other goals too.
I mentioned wanting to be a mom.
That was something that I knewI wanted to do sooner than later
.
So he had said what about beinga dentist?
So then I started to look intothat and then I did some
shadowing of dentists andrealized that wasn't going to be
for me.
So then I looked into what elseI wanted to do and he had a
(31:20):
great friend that was a PA.
So I spent some time with him.
He was like a very autonomous,loved his job.
He was a community guy.
He had been around for manydecades and I'm like this would
be perfect.
So I decided to go to PA school.
I went to school inPhiladelphia, had a wonderful I
feel like I had a really greateducation there.
I came out feeling ready to dothis and I got into
(31:43):
cardiothoracic surgery when Ifirst became a PA in 2006.
Then I moved on.
I really loved the intensivecare or critical care piece of
T-surgery, so we moved around alittle bit before we settled
down.
I worked in critical care forjust about a decade or so and
then I realized that when thekids were young, that I needed
(32:04):
something more stable.
So I went into cardiology forabout eight years or so, which
was definitely my favorite.
I just absolutely lovecardiology.
But I started to feel like Iwanted to do more and so, after
doing the same thing, what seemsevery day, even though I love
the patients and love being ableto help them I just I felt like
(32:25):
there was more that I could do.
I think the pandemic reallyturned my attention towards
clinical research because, ofcourse, we were trying to roll
out a vaccine quickly and I wasjust curious about the process.
I started doing a lot ofresearch and reading a lot of
scholarly articles during thattime, and so that's what made me
start to look into this more,and I found a local research
(32:47):
site and, though they didn'thave a position available, I
reached out and so, having donethat, when a job became
available, they contacted me,and so that's how I started
there Two years ago.
I was very, very nervous totake the plunge, but I'm
(33:07):
grateful that I did, becausethere's just so much more out
there.
I think if I had stayed incardiology and I might not have
had the energy to go on to getmy doctorate of medical science,
which was a goal of mine, andI'm grateful that this job had
gave me that energy, thatwork-life balance to be able to
(33:28):
go out and do that.
With working full-time andhaving a family and teenage kids
, that you know, all the taxiingaround to different events.
It's been really great and Ifeel very fortunate that I was
called to do this, and I'mexcited about the future for
sure.
Ashley (33:43):
I feel very fortunate that I was called to do this and
I'm excited about the futurefor sure.
What a fantastic career journeyfrom cardiothoracic surgery to
critical care to cardiology.
You've seen patients at theirworst and you've cared for them
then and now, doing what you'redoing, you have your doctorate
of medical science.
You know, I, I just, you know,I just I loved what you just
said about realizing we PAs, wework clinicians, generally
(34:09):
speaking, we work in a fantasticfield and yet there's always
that desire of wanting to domore and there was more that you
can do.
And I think that is so amazingas a PA these days is that the
doors are really opening forthis profession, for PAs and for
MPs, and and we're being,generally speaking, I think
(34:29):
we're being very welcomed by the, by the healthcare community,
into these roles and it's sointeresting.
I'm so glad that you said thatabout the pandemic.
Covid comes up in everyconversation.
I absolutely never include iton the question list and it
always, always, always comes up,and I think yours is an
interesting take on thecoronavirus vaccine.
(34:50):
We have to admit that theprocess was interesting and you
found that interest and youchased it and look what you're
doing now.
Because of that.
It is just.
It is so cool.
I'm just so amazed by you andwhat you're doing and I applaud
you.
Let's talk to our pre-healthstudents.
What skills should they focuson developing if they're looking
(35:12):
towards a career eventually inclinical research?
Leigh (35:18):
Yeah, I think it's important to get the sciences in
and things like that, like younormally would with any
pre-health type of role.
But for research, you can lookinto trainings like CITI is a
type of training and they havedifferent courses in good
clinical practice or it's calledGCP.
(35:39):
So a good clinical practice orGCP is something that you'd have
to get trained in, and theother thing is HSP, which is
human subjects protection, andthose things are not.
If there was a PA who wasinterested in being a
sub-investigator or somethingit's not something you'd have to
go out and do before, but ifyou had that, if you had done
that training, that would looklike you were motivated, I think
(36:01):
, for a potential employer or ifyou were looking to get into
this type of work.
If you have done any of thatresearch, it's very important.
All, like I mentioned, all thisreally focuses around safety of
patients and keeping that atthe forefront really of all the
work that we do.
Ashley (36:17):
That is so great, Lee.
Thank you so much for joiningus on Shadow Me Next.
It has been an absolutepleasure.
Thank you so much for joiningus on Shadow Me Next.
It has been an absolutepleasure.
Leigh (36:25):
Thank you so much, ashley, I really appreciate it.
Ashley (36:28):
Thank you so very much for listening to this episode of
Shadow Me Next.
If you liked this episode or ifyou think it could be useful
for a friend, please subscribeand invite them to join us next
Monday, as always.
If you have any questions, letme know on Facebook or Instagram
Access.
You want stories you needquestions?
Let me know on Facebook orInstagram Access.
You want stories you need?
You're always invited to shadowme next.
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