February 21, 2025 • 26 mins
Rheumatologist Dr. Manish Jain joins Cardiologist Dr. Michael Koren as they discuss how performing clinical trials can help physicians become more holistic and knowledgeable, and how the process can result in better care for patients. In this conversation, the principal investigators explore Dr. Manish's journey as a clinician and investigator, including how he learned to approach patients about research, understanding their motivations, and the importance of education in bridging clinical practice with research.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Announcer (00:00):
Welcome to MedEvidence!, where we help you
navigate the truth behindmedical research with unbiased,
evidence-proven facts.
Hosted by cardiologist and topmedical researcher, Dr Michael
Koren.
Dr. Michael Koren (00:11):
Hello, I'm Dr .
Michael Koren, the executiveeditor of MedEvidence!, and I
always love to interview akindred spirit and I have a
kindred spirit today Dr.
Manish Jain, who is a clinicalinvestigator out of the Chicago
area.
He's braving the coldtemperatures there we were just
(00:31):
talking about that but we'reexcited that you found a warm
spot to talk about somethingthat's warm in both of our
hearts, which is how to reachout to your community and talk
to people about clinicalresearch.
So, one, welcome to MedEvidence! And two, why don't you
just introduce yourself to ouraudience and tell us a little
bit about yourself?
Dr. Manish Jain (00:51):
Yeah, definitely.
My name is Manish Jain.
I am a board-certifiedrheumatologist and internist and
I run a busy private practiceon the north side of Chicago.
We take great care of our Cubsfans.
If you're a White Sox fan,
You're in big trouble.
But and so, yeah, it's me and really a
(01:12):
wonderful clinical team.
And then, beyond that, I alsoserve as a principal
investigator and I'm reallybased at our research site which
is adjacent to my clinic.
I'm also the regional medicaldirector for Flourish within our
Midwest region, so I helpoversee now a handful and a
(01:35):
growing handful of researchsites here in the Midwest.
Dr. Michael Koren (01:38):
Yeah, and I will state that I love White Sox
fans, so you can find somebodythat loves everybody in our
organization.
So that's a great introduction,thank you.
So how'd you get involved inclinical research?
What was the impetus?
Dr. Manish Jain (01:54):
Yeah, so I had been interacting with a
standalone research center gosh,this was maybe eight, 10 years
ago and so participating as aprincipal investigator really in
studies that were you know kindof bread and butter for a
rheumatologist to participate in.
I think about a study for youknow a new agent for rheumatoid
(02:15):
arthritis or you know a newagent for gout osteoarthritis.
You know, these are kind of thebread and butter conditions
that I see as a rheumatologist.
And you know, I kind of startedoff doing it as a little bit of
a hobby.
It was just like a fun thingfor me to offer to patients and
just kind of kept thingsexciting for me in clinic.
And so I did that for a while.
(02:38):
And then COVID happened and theneverything just changed right,
changed for all this, changedfor our patients, changed for
our colleagues alike.
So during COVID a lot of theyou know, especially kind of
really early on, when thepandemic was at its fiercest, a
lot of our patients suffered inthe hospital with really serious
(02:58):
forms of inflammation in theirbody, especially in their lungs,
and so pretty early on many ofthe medicines I use as a
rheumatologist of high interestto kind of help fight that
inflammation brought on by COVIDand so kind of a you know weird
wild story.
One of the agents was actuallya JAK inhibitor, Janus
(03:23):
Activating Kinase Inhibitor.
We were studying it inrheumatoid arthritis, and so an
opportunity presented itself toperform a study with the same
drug, but in an inpatientsetting for COVID patients.
And so basically you know,myself and a handful of resident
(03:44):
physicians, training physicians, banded together and during the
height of the pandemic, when wereally just didn't have a lot
of options to offer our patients, we didn't have any clinical
trials going on at our kind ofsmaller community hospital.
We enrolled 55 patients in thehospital.
So that was kind of a biginflection point and really
(04:05):
helped me kind of understand thepower of clinical trials in
just a really really differentway and just how, even though my
lane is just a little bitnarrower as a rheumatologist how
really it can be applied morebroadly to all of our patients
(04:27):
in need.
So that's my story.
Dr. Michael Koren (04:29):
Well, that's interesting, so I'm in suspense.
Did the JAK inhibitor work forCOVID patients?
Dr. Manish Jain (04:34):
It did.
It actually reached an FDAapproval.
I was really proud to see adrug from its inception, even
helping a sponsor come up withhow to study the medicine,
giving input and seeing it allthe way to an FDA approval.
Really a very special.
Dr. Michael Koren (04:56):
Very exciting , that's fabulous.
So how long did it take you toget comfortable approaching
patients about research?
And do most patients look atyou skeptically when you present
this concept to them, or how dothey respond to you?
So I bring this up because alot of physicians are just
intrinsically uncomfortable withapproaching patients about
(05:18):
research opportunities, andthat's a very important part of
the skill set of an accomplishedclinical trial professional.
Dr. Manish Jain (05:25):
Yeah, I see a lot of synergies with how I talk
to a patient in clinic.
I might be presenting them, youknow, a new therapeutic option
and I'm going to present prosand cons, risks and benefits.
And I drive, I lean on thatexperience quite a bit when I'm
(06:14):
speaking to patient about aclinical trial.
Many time, not all the time,but many times these are
patients I've had years longrelationship with.
You know, I know theirfamilies, I know just a lot
about the patient.
Not all the time though,sometimes its a new patients I'm
presenting it to.
I think just having an honest,transparent discussion; I think
just knowing what I'm talkingabout is also really important,
just like I need to know whatI'm talking about when I'm
presenting a trial to a patient,be able to field questions and
not just turf them to anotherteam member, not just, you know,
turf them to another teammember and I think, really just
understanding where the patientis coming from, what motivates
them.
You know many of my patientsare driven by altruism.
(06:35):
They want to help.
Many of my patients will signup for it because they want to
help everyone who'simmunocompromised.
So, just like in clinic,understanding the patient's
value system and understandingif and how a trial can kind of
fit that value system.
Dr. Michael Koren (06:54):
Do you have any things you can share with us
on how you can assess that, anylittle turns of phrases or ways
that you get clued into whatwould drive a patient, get them
interested in clinical research?
Dr. Manish Jain (07:07):
Yeah.
So I think first it's like justidentifying the clinical need.
If I have a patient in need,the need could be for so many
reasons they don't have accessto a certain treatment.
The need could be that you knowthis is really something new
for them, they, you know.
So understanding that need andthen really tying how I speak to
(07:29):
a patient based on that need.
So I'll just give an example we, you know, one of the bigger
studies I enrolled into was notlooking at a vaccine.
It was looking at something alittle bit different, a
monoclonal antibody.
So it's a monoclonal antibodythat would help potentially
protect patients against aninfection In this case it was
(07:50):
COVID and so helping explain toa patient.
Vaccines are super importantfor my immunocompromised patient
, but vaccines don't alwaysuptake quite as well.
They don't always work quite aswell in my immunocompromised
folks, just because it might bethe disease itself, it might be
(08:10):
the medication that I'm requiredto use and so helping my
patient understand well, listen,this is a way to potentially
supplement that vaccine response.
So I think understanding andthat was in that that you know
was quite motivating for for alot of my patients so I think,
uh, understanding where they'recoming from, explaining it in
(08:32):
lay terms and and leaning onkind of my experience as a
clinician and having discussionswith patients, that that's,
that's what I, that's what I'veused.
Dr. Michael Koren (08:41):
Right, yeah.
And there are also socialsituations for people.
Either people are strugglingwith their finances or people
are having difficulty affordinga certain medication.
Often, that can drive ourdiscussion with regard to why a
patient might be interested insomething that we're doing.
Dr. Manish Jain (09:01):
Absolutely, and even something as simple as
transportation.
You know I'll have patients whoyou know they'll come see me on
my clinic side.
Unfortunately, I cannot providetransportation for a patient
when they're coming to see mefor a clinic visit.
We can provide it, often in thecontext of a clinical trial
visit, and so, you know,sometimes I have to remind my
(09:23):
patient, you know they oh,you're here for a clinic visit
today and of a clinical trialvisit, and so you know,
sometimes I have to remind mypatient, oh, you're here for a
clinic visit today and not aclinical trial visit.
Dr. Michael Koren (09:29):
Yeah, so just for the audience, when we run
clinical trials, we compete forgrants and the grants include
stipends, often for patients,including their expenses, and
sometimes the stipends can beused for other medications that
are important for them to be onas part of the research.
So there's a lot ofopportunities that we have a
(09:49):
little discretion over notcomplete discretion, but some
discretion.
Dr. Manish Jain (09:53):
And the other thing that I'll lead on a lot is
helping patients understand allthe close monitoring that
they're going to receive.
I'll give one example.
We had a patient enrolled inone of our cardiovascular
studies.
This wasn't my practice patient, but it was a patient of a
close colleague of mine who's acardiologist, and so we were
(10:15):
just doing like a standard phonecheckup on this patient.
I have a really smart physicianassistant on the research side
who just picked up the patientjust sounded a little short of
breath, just didn't sound right,and so that patient was
actually in midst of a flare oftheir congestive heart failure
and I was picking it up over thephone and we you know the
(10:38):
patient just didn't have theopportunity yet to bring it up
to his cardiologist, but wepicked up on it first and that
patient went right away to theemergency room.
So that's just one example, butthis happens day in and day out
in our practice.
Dr. Michael Koren (10:52):
Yeah, yeah, that's a great point.
And an ancillary point is thatwhen you develop a skill set as
a clinical trialist, it kind ofoverlaps your therapeutic
expertise clinical trial list.
So I'm a cardiologist and,like you, I was involved in the
(11:13):
COVID trials, mostly the COVIDvaccines, and it's not because I
was an expert in virology orinfectious diseases or vaccines,
it's because I knew how to runclinical trials.
And all of a sudden we had ascale clinical trials where
we're putting hundreds of peoplein in a very short period of
time as part of operation warpspeed.
Both you as a rheumatologist andme as a cardiologist are
sometimes doing the same studies, but we can bring different
(11:33):
things to the table.
So, for example, I know thatwe're both involved in lipid
studies, looking at, for example, lipoprotein(a), which is a
form of LDL cholesterol thatseems to be particularly
atherogenic and runs in families.
And so how do you, as arheumatologist, talk to people
(11:54):
about something that may be alittle bit different than what
you would talk about in theclinic but is relevant in terms
of your skills as a clinicaltrialist?
Dr. Manish Jain (12:06):
Yeah, and the way I look at Lp(a) is we may
not be talking about in clinic,but we ought to be.
So this was a real evolutionkind of in my thinking and, just
frankly, my education as well.
So we know that my patientswith rheumatic disease let's
just use rheumatoid arthritis asan example are at a much higher
risk for cardiovascular disease.
(12:28):
So we actually think ofrheumatoid arthritis as probably
a diabetes level risk for theformation of heart disease and
we ought to be talking about ourpatients about modifiable risk.
You know we ought to be talkingto patients about statins.
We may not be managing theirstatins in a rheumatology
practice, but we should beeyeballing their medication list
(12:51):
and you know, say hey you gotto talk to your primary care
doctor and you know, see if youknow if we can get you on, you
know, on this risk mitigationtreatment.
So when it comes to somethinglike Lp( a), it's it's actually
really fun for me in clinic tobring it up to a patient and you
know, I kind of described, asyou know, maybe it's like a
stickier cholesterol and it'sbeen tied to you know, these bad
(13:14):
outcomes and it's it'ssomething that we don't think
you can diet or exercise yourway out of, but it probably does
drive a lot of the risk for,you know, for bad events and up
till now, you know, didn'treally have anything to offer
other than, you know, justchecking it.
But that's changed in thecontext of a clinical trial.
(13:35):
Not only can we check it, knowyour number, know your risk, but
we may be able to do somethingabout it in the context of a
study, and so when I present itto patients, they're usually
very excited to not just havethe level checked but, if it's
high, to think about doingsomething about it.
Dr. Michael Koren (13:52):
Yeah, and then another area of overlap is
the concept of inflammation.
You talked a little bit aboutthat before, but it's been well
known that patients, for example, that have rheumatoid arthritis
are at higher risk forcardiovascular events compared
to match patients that don'thave rheumatoid arthritis.
So is that an area of focus orconcern, or how do you express
(14:13):
that to your folks?
Dr. Manish Jain (14:15):
Yeah, so quite a bit right.
We know that our patients whohave tighter disease control for
their inflammation, for theirrheumatoid arthritis over time
have better cardiovascularoutcomes.
Study after study has shownthat.
So that's another opportunityto engage a patient, either in
clinic, maybe in a clinicaltrial.
That you know your rheumatoidarthritis is uncontrolled,
(14:39):
you're on a ton of prednisone,as an example, which we know is
connected to cardiovascular risk, and we've got to get this
disease under control, be itthrough an agent that's FDA
approved, that I've got accessto samples in my fridge, or be
it through a clinical trial forrheumatoid arthritis, just as an
example.
So really helping patients kindof understand.
(15:00):
You know, I'm somehow very fondof telling my patients in the
clinic like I care about yourpain.
I do, I care about it.
What I really care about is allthis systemic inflammation.
I care about your heart attackrisk, your infection risk over
time, and my job is to reallyhelp stamp out this inflammation
and help mitigate risks while Ido it.
(15:22):
So that's something where I getmy practice and my trial
practice a lot.
Dr. Michael Koren (15:29):
Yeah, and that's an important holistic
view.
And so interestingly andperhaps counterintuitively, even
though we may be focused on onequestion, when we do clinical
trials, we actually have tothink about patients
holistically.
So, as you point out, peoplethat have inflammatory
conditions such as rheumatoidarthritis, may be at mortality
(15:51):
risk from cardiovascular events,and by talking to them about
that, you're actually taking avery holistic view of the
patient.
Dr. Manish Jain (15:57):
Yeah, absolutely.
I think my passion in liferight why I feel like I was put
on this earth was to improve thelives of my immunocompromised
patients.
Ten years ago I think I hadkind of a myopic view of that.
Right, I was going to improvetheir lives within the context
of the medicines that I, as arheumatologist, classically
(16:18):
would prescribe.
But now my perspective is somuch different.
Right, I still am prescribingthose medicines and you know,
I'm getting their disease undertight control.
But I'm also thinking abouttheir BMI, I'm also thinking
about their lipids, I'm alsothinking about their vaccination
status.
I'm also thinking about, youknow, have they gotten up to
date on a malignancy screening?
(16:40):
So these are all ways that Ithink I'm convinced.
I don't think I'm convincedthat the trials have made me
into a better clinician.
Dr. Michael Koren (16:50):
Yeah, and that's very, very well said.
So I'm going to switch gears onyou a little bit, and I also
know that you're passionateabout physician education and in
fact, you're going to join mehere in Jacksonville in April to
do a physician training courseon how to become more effective
as a clinical trialist and, ofcourse, teaching doctors who may
(17:12):
not be that familiar with theconcept of GCP or Good Clinical
Practices what that means andthat that is one of the elements
of the skill set that a goodclinical trialist has the many
other elements that we get intoduring the course.
So just tell us a little bitabout how you got interested in
the physician training piece andmaybe some of your strategies
(17:34):
on how physicians learn best.
Dr. Manish Jain (17:37):
Yeah, absolutely I love teaching.
It's been a part of my careerfor quite some time.
So actually before I got reallybusy with clinical trials, I
participated quite a bit inresident education.
I was actually a programdirector for a transitional year
program.
That's a training stopping pointfor a future radiologist or
(17:58):
dermatologist and being able tolecture about rheumatic diseases
.
You know, I think sometimessome of my conditions kind of
are a little, they almost feel alittle mystical or confusing
even to medical trainees, and sodemystifying it.
You know, helping helping ourdocs understand how to recognize
(18:19):
and refer, maybe even take careof patients with our conditions
has always been a fulfillingpart of what I do.
It's really fun for me now tobring in the clinical trial
aspect into that and teach, youknow, training doctors about
well, okay, you're prescribingthis medicine, how did that
(18:40):
medicine come about?
Helping them understand how toread a study right, what are you
supposed to look at when you'reevaluating a study.
You know what are some of thequestions you should kind of
poke at a little bit when you'reevaluating a study.
So I'd say, being able to kindof educate trainees on the
(19:01):
clinical trial process and justhow to critically evaluate you
know data as it comes out Superfun, super fulfilling for me.
Dr. Michael Koren (19:09):
Yeah, that's.
A great point is that it may bea bit of a lost art, but
reading a technical journalpublication is something that
not all physicians areparticularly good at, and once
you have some clinical trialexperience you get much better
at that and it really enhancesyour understanding of the
(19:30):
particular project, thehypothesis that's being tested,
the therapeutic area and alsothe interface between your
patients and what they can getout of the latest and greatest
in that therapeutic area.
So I think we do spend a littlebit of time on how to read the
literature during our trainingprogram.
Dr. Manish Jain (19:49):
Yeah, absolutely it almost.
You know, when you get kind ofinvolved in this clinical trial
world, you really get this veryfoundational, fundamental,
in-depth understanding of thestudies and you know it's almost
like you, almost you startfollowing studies, like you
start following sports if you'rean avid sports fan.
You really know the ins andouts of them and you bring that
(20:13):
back into clinic on a day-to-daybasis and that's really fun is
being able to close that loopfor patients.
Dr. Michael Koren (20:20):
Yeah, absolutely.
And this next question mayreflect my bias but how do you
feel about this standard oftraining quote, unquote, and I
put that in big, big quoteswhere somebody says, okay, look
at this website, doctor, andlisten to it for 30 minutes and
then you're trained versus someof the experiential training
(20:44):
that we typically did back inresidency and fellowship and
what I believe is a great way totrain people after our quote,
formal training?
Dr. Manish Jain (20:55):
Yeah, so I I saw the evolution of medical
training and kind of the changeof what it's turned into now
during my medical training, youknow.
I mean we were kind of the from2006-2009, kind of the trailing
end of the last days of thegiants, where you know you had
the you know overnights in thehospital, 30 hour, uh, training
(21:19):
shifts and, and it wasn't to saythat it was all good.
Right, I mean there were somenegatives there, it was tired
and you know, but but really I,I like I'm, I'm really thankful
that I had that opportunity.
I don't think I'd be the samedoctor if I had dreamed uh if,
if I didn't have thatopportunity during during my
(21:40):
training, to have those long,long uh you know nights bleeding
into days and be able to carefor my patient with with that
continuity.
Dr. Michael Koren (21:54):
Yeah, no doubt we were just talking about
that earlier today that youknow, when I was training, being
on call every other night formonths at a time was not unusual
and we had shifts up to 36hours.
And that part of medicine froma training perspective has gone
away, and I think, probably forthe worst overall, although, to
your point, we don't need peoplenecessarily absolutely fatigued
(22:15):
making important decisions, butthere's ways to deal with that.
But getting to the more broadquestion, in clinical research,
what's the most effective way toteach other people to get up to
speed?
Dr. Manish Jain (22:35):
Yeah, I think it's got to be multimodal, and
so I think there's a role formodules and, you know,
standardized, formalizedtraining.
There's a role for, you know,lectures.
There's definitely that.
That's, I think, a corecomponent of the foundation.
There's a role for doing aswell.
You know, to be thatinvestigator, to perform the
assessments, to have that directpatient-facing contact as well,
is really important.
(22:56):
But I think there's that thirdpillar that has, for me, helped
make me the investigator I amtoday, and that's mentorship.
And it's sometimes hard to findmentorship within clinical
trials.
For me, that's been.
I think, one of the mostexciting things about being part
of a clinical trial networklike Flourish Research is that I
(23:19):
don't just have access toamazing patients and amazing
studies, but I have access toamazing mentors, and that has
just been really, reallyimportant and a big driver of my
growth over time.
Dr. Michael Koren (23:35):
Yeah, no doubt the concept of mentors has
been extraordinarily importantfor me and to your point, when
you're just looking at onlinemodules, you don't get that
sense, and there's very manysofter points of being effective
as a clinical physician and asa clinical trialist that you're
(23:58):
just not going to get other thanthrough experience and watching
how other people do things andfinding your niche.
You don't have to do exactlythe things the way your mentor
did, but at least you seedifferent styles and that
eventually helps you develop astyle that you get really
comfortable with and get reallygood at.
So I think that's superimportant.
So, Manish, this has been afabulous conversation.
(24:19):
Before we sign off, are thereany other major things you'd
like to share with the audiencewith regard to your career
experiences, your interfaces inclinical research?
Dr. Manish Jain (24:36):
Yeah, to me, I think it's just.
It's all about the synergy Ireally lean on.
You know the things that.
I hope make me a strongclinician, you know, I think,
directly carry over into beingan investigator.
There's definitely differencesas well, but to me I kind of see
it's more about the synergiesand similarities of the two.
And I guess the last otherclosing thought I'll leave you
(24:58):
with is it's super fun.
You know, I think we all Dr.
Koren, you and I both have somecolleagues that maybe aren't
having as much fun as they oughtto be practicing medicine,
right, I think we you know we wesee high rates of medical
burnout, just just as as anexample in our profession.
I really think to get toparticipate as an investigator
(25:19):
and kind of carry these dualroles, like you and I do, it's
really fulfilling and and Ithink we wake up just with a lot
of purpose and a lot ofexcitement and excitement and
ready to tackle the day, and forthat I'm truly thankful.
Dr. Michael Koren (25:32):
Yeah, and you alluded to this, but part of
our medical culture as oldschool physicians is that we do
clinical practice, research andteaching.
It's all part of this trilogythat are very, very important to
us, that fulfill us as as uh,as physicians, as physicians
that want to be a cut aboveother people, and, um, research
(25:56):
is a big part of that.
So, Manish, uh, yeah, this hasbeen a great interview and I
just want to say that we'll havesome show notes that give
people information about howthey may want to participate in
our training session coming upat the University of North
Florida in April, and so weencourage people physicians this
(26:17):
is really physician-focused tolook into that and learn more
from folks like us and othermembers of our educational group
that will be talking about themany, many elements of clinical
research that you may want toget involved with or, if you've
been a little involved with, youmay want to make your skills
get to a higher level throughthis type of interaction.
So, again, I'm excited to workwith you at the University of
(26:38):
North Florida in April.
We'll have more information onthe show notes and thank you so
much for being part ofMedEvidence!
Dr. Manish Jain (26:45):
Thanks for having me Really appreciate it.
Announcer (26:47):
Thanks for joining the MedEvidence! podcast.
To learn more, head over toMedEvidence.
com or subscribe to our podcaston your favorite podcast
platform.
Welcome to MedEvidence!, where we help you
navigate the truth behindmedical research with unbiased,
evidence-proven facts.
Hosted by cardiologist and topmedical researcher, Dr Michael
Koren.
Dr. Michael Koren (00:11):
Hello, I'm Dr .
Michael Koren, the executiveeditor of MedEvidence!, and I
always love to interview akindred spirit and I have a
kindred spirit today Dr.
Manish Jain, who is a clinicalinvestigator out of the Chicago
area.
He's braving the coldtemperatures there we were just
(00:31):
talking about that but we'reexcited that you found a warm
spot to talk about somethingthat's warm in both of our
hearts, which is how to reachout to your community and talk
to people about clinicalresearch.
So, one, welcome to MedEvidence! And two, why don't you
just introduce yourself to ouraudience and tell us a little
bit about yourself?
Dr. Manish Jain (00:51):
Yeah, definitely.
My name is Manish Jain.
I am a board-certifiedrheumatologist and internist and
I run a busy private practiceon the north side of Chicago.
We take great care of our Cubsfans.
If you're a White Sox fan,
You're in big trouble.
But and so, yeah, it's me and really a
(01:12):
wonderful clinical team.
And then, beyond that, I alsoserve as a principal
investigator and I'm reallybased at our research site which
is adjacent to my clinic.
I'm also the regional medicaldirector for Flourish within our
Midwest region, so I helpoversee now a handful and a
(01:35):
growing handful of researchsites here in the Midwest.
Dr. Michael Koren (01:38):
Yeah, and I will state that I love White Sox
fans, so you can find somebodythat loves everybody in our
organization.
So that's a great introduction,thank you.
So how'd you get involved inclinical research?
What was the impetus?
Dr. Manish Jain (01:54):
Yeah, so I had been interacting with a
standalone research center gosh,this was maybe eight, 10 years
ago and so participating as aprincipal investigator really in
studies that were you know kindof bread and butter for a
rheumatologist to participate in.
I think about a study for youknow a new agent for rheumatoid
(02:15):
arthritis or you know a newagent for gout osteoarthritis.
You know, these are kind of thebread and butter conditions
that I see as a rheumatologist.
And you know, I kind of startedoff doing it as a little bit of
a hobby.
It was just like a fun thingfor me to offer to patients and
just kind of kept thingsexciting for me in clinic.
And so I did that for a while.
(02:38):
And then COVID happened and theneverything just changed right,
changed for all this, changedfor our patients, changed for
our colleagues alike.
So during COVID a lot of theyou know, especially kind of
really early on, when thepandemic was at its fiercest, a
lot of our patients suffered inthe hospital with really serious
(02:58):
forms of inflammation in theirbody, especially in their lungs,
and so pretty early on many ofthe medicines I use as a
rheumatologist of high interestto kind of help fight that
inflammation brought on by COVIDand so kind of a you know weird
wild story.
One of the agents was actuallya JAK inhibitor, Janus
(03:23):
Activating Kinase Inhibitor.
We were studying it inrheumatoid arthritis, and so an
opportunity presented itself toperform a study with the same
drug, but in an inpatientsetting for COVID patients.
And so basically you know,myself and a handful of resident
(03:44):
physicians, training physicians, banded together and during the
height of the pandemic, when wereally just didn't have a lot
of options to offer our patients, we didn't have any clinical
trials going on at our kind ofsmaller community hospital.
We enrolled 55 patients in thehospital.
So that was kind of a biginflection point and really
(04:05):
helped me kind of understand thepower of clinical trials in
just a really really differentway and just how, even though my
lane is just a little bitnarrower as a rheumatologist how
really it can be applied morebroadly to all of our patients
(04:27):
in need.
So that's my story.
Dr. Michael Koren (04:29):
Well, that's interesting, so I'm in suspense.
Did the JAK inhibitor work forCOVID patients?
Dr. Manish Jain (04:34):
It did.
It actually reached an FDAapproval.
I was really proud to see adrug from its inception, even
helping a sponsor come up withhow to study the medicine,
giving input and seeing it allthe way to an FDA approval.
Really a very special.
Dr. Michael Koren (04:56):
Very exciting , that's fabulous.
So how long did it take you toget comfortable approaching
patients about research?
And do most patients look atyou skeptically when you present
this concept to them, or how dothey respond to you?
So I bring this up because alot of physicians are just
intrinsically uncomfortable withapproaching patients about
(05:18):
research opportunities, andthat's a very important part of
the skill set of an accomplishedclinical trial professional.
Dr. Manish Jain (05:25):
Yeah, I see a lot of synergies with how I talk
to a patient in clinic.
I might be presenting them, youknow, a new therapeutic option
and I'm going to present prosand cons, risks and benefits.
And I drive, I lean on thatexperience quite a bit when I'm
(06:14):
speaking to patient about aclinical trial.
Many time, not all the time,but many times these are
patients I've had years longrelationship with.
You know, I know theirfamilies, I know just a lot
about the patient.
Not all the time though,sometimes its a new patients I'm
presenting it to.
I think just having an honest,transparent discussion; I think
just knowing what I'm talkingabout is also really important,
just like I need to know whatI'm talking about when I'm
presenting a trial to a patient,be able to field questions and
not just turf them to anotherteam member, not just, you know,
turf them to another teammember and I think, really just
understanding where the patientis coming from, what motivates
them.
You know many of my patientsare driven by altruism.
(06:35):
They want to help.
Many of my patients will signup for it because they want to
help everyone who'simmunocompromised.
So, just like in clinic,understanding the patient's
value system and understandingif and how a trial can kind of
fit that value system.
Dr. Michael Koren (06:54):
Do you have any things you can share with us
on how you can assess that, anylittle turns of phrases or ways
that you get clued into whatwould drive a patient, get them
interested in clinical research?
Dr. Manish Jain (07:07):
Yeah.
So I think first it's like justidentifying the clinical need.
If I have a patient in need,the need could be for so many
reasons they don't have accessto a certain treatment.
The need could be that you knowthis is really something new
for them, they, you know.
So understanding that need andthen really tying how I speak to
(07:29):
a patient based on that need.
So I'll just give an example we, you know, one of the bigger
studies I enrolled into was notlooking at a vaccine.
It was looking at something alittle bit different, a
monoclonal antibody.
So it's a monoclonal antibodythat would help potentially
protect patients against aninfection In this case it was
(07:50):
COVID and so helping explain toa patient.
Vaccines are super importantfor my immunocompromised patient
, but vaccines don't alwaysuptake quite as well.
They don't always work quite aswell in my immunocompromised
folks, just because it might bethe disease itself, it might be
(08:10):
the medication that I'm requiredto use and so helping my
patient understand well, listen,this is a way to potentially
supplement that vaccine response.
So I think understanding andthat was in that that you know
was quite motivating for for alot of my patients so I think,
uh, understanding where they'recoming from, explaining it in
(08:32):
lay terms and and leaning onkind of my experience as a
clinician and having discussionswith patients, that that's,
that's what I, that's what I'veused.
Dr. Michael Koren (08:41):
Right, yeah.
And there are also socialsituations for people.
Either people are strugglingwith their finances or people
are having difficulty affordinga certain medication.
Often, that can drive ourdiscussion with regard to why a
patient might be interested insomething that we're doing.
Dr. Manish Jain (09:01):
Absolutely, and even something as simple as
transportation.
You know I'll have patients whoyou know they'll come see me on
my clinic side.
Unfortunately, I cannot providetransportation for a patient
when they're coming to see mefor a clinic visit.
We can provide it, often in thecontext of a clinical trial
visit, and so, you know,sometimes I have to remind my
(09:23):
patient, you know they oh,you're here for a clinic visit
today and of a clinical trialvisit, and so you know,
sometimes I have to remind mypatient, oh, you're here for a
clinic visit today and not aclinical trial visit.
Dr. Michael Koren (09:29):
Yeah, so just for the audience, when we run
clinical trials, we compete forgrants and the grants include
stipends, often for patients,including their expenses, and
sometimes the stipends can beused for other medications that
are important for them to be onas part of the research.
So there's a lot ofopportunities that we have a
(09:49):
little discretion over notcomplete discretion, but some
discretion.
Dr. Manish Jain (09:53):
And the other thing that I'll lead on a lot is
helping patients understand allthe close monitoring that
they're going to receive.
I'll give one example.
We had a patient enrolled inone of our cardiovascular
studies.
This wasn't my practice patient, but it was a patient of a
close colleague of mine who's acardiologist, and so we were
(10:15):
just doing like a standard phonecheckup on this patient.
I have a really smart physicianassistant on the research side
who just picked up the patientjust sounded a little short of
breath, just didn't sound right,and so that patient was
actually in midst of a flare oftheir congestive heart failure
and I was picking it up over thephone and we you know the
(10:38):
patient just didn't have theopportunity yet to bring it up
to his cardiologist, but wepicked up on it first and that
patient went right away to theemergency room.
So that's just one example, butthis happens day in and day out
in our practice.
Dr. Michael Koren (10:52):
Yeah, yeah, that's a great point.
And an ancillary point is thatwhen you develop a skill set as
a clinical trialist, it kind ofoverlaps your therapeutic
expertise clinical trial list.
So I'm a cardiologist and,like you, I was involved in the
(11:13):
COVID trials, mostly the COVIDvaccines, and it's not because I
was an expert in virology orinfectious diseases or vaccines,
it's because I knew how to runclinical trials.
And all of a sudden we had ascale clinical trials where
we're putting hundreds of peoplein in a very short period of
time as part of operation warpspeed.
Both you as a rheumatologist andme as a cardiologist are
sometimes doing the same studies, but we can bring different
(11:33):
things to the table.
So, for example, I know thatwe're both involved in lipid
studies, looking at, for example, lipoprotein(a), which is a
form of LDL cholesterol thatseems to be particularly
atherogenic and runs in families.
And so how do you, as arheumatologist, talk to people
(11:54):
about something that may be alittle bit different than what
you would talk about in theclinic but is relevant in terms
of your skills as a clinicaltrialist?
Dr. Manish Jain (12:06):
Yeah, and the way I look at Lp(a) is we may
not be talking about in clinic,but we ought to be.
So this was a real evolutionkind of in my thinking and, just
frankly, my education as well.
So we know that my patientswith rheumatic disease let's
just use rheumatoid arthritis asan example are at a much higher
risk for cardiovascular disease.
(12:28):
So we actually think ofrheumatoid arthritis as probably
a diabetes level risk for theformation of heart disease and
we ought to be talking about ourpatients about modifiable risk.
You know we ought to be talkingto patients about statins.
We may not be managing theirstatins in a rheumatology
practice, but we should beeyeballing their medication list
(12:51):
and you know, say hey you gotto talk to your primary care
doctor and you know, see if youknow if we can get you on, you
know, on this risk mitigationtreatment.
So when it comes to somethinglike Lp( a), it's it's actually
really fun for me in clinic tobring it up to a patient and you
know, I kind of described, asyou know, maybe it's like a
stickier cholesterol and it'sbeen tied to you know, these bad
(13:14):
outcomes and it's it'ssomething that we don't think
you can diet or exercise yourway out of, but it probably does
drive a lot of the risk for,you know, for bad events and up
till now, you know, didn'treally have anything to offer
other than, you know, justchecking it.
But that's changed in thecontext of a clinical trial.
(13:35):
Not only can we check it, knowyour number, know your risk, but
we may be able to do somethingabout it in the context of a
study, and so when I present itto patients, they're usually
very excited to not just havethe level checked but, if it's
high, to think about doingsomething about it.
Dr. Michael Koren (13:52):
Yeah, and then another area of overlap is
the concept of inflammation.
You talked a little bit aboutthat before, but it's been well
known that patients, for example, that have rheumatoid arthritis
are at higher risk forcardiovascular events compared
to match patients that don'thave rheumatoid arthritis.
So is that an area of focus orconcern, or how do you express
(14:13):
that to your folks?
Dr. Manish Jain (14:15):
Yeah, so quite a bit right.
We know that our patients whohave tighter disease control for
their inflammation, for theirrheumatoid arthritis over time
have better cardiovascularoutcomes.
Study after study has shownthat.
So that's another opportunityto engage a patient, either in
clinic, maybe in a clinicaltrial.
That you know your rheumatoidarthritis is uncontrolled,
(14:39):
you're on a ton of prednisone,as an example, which we know is
connected to cardiovascular risk, and we've got to get this
disease under control, be itthrough an agent that's FDA
approved, that I've got accessto samples in my fridge, or be
it through a clinical trial forrheumatoid arthritis, just as an
example.
So really helping patients kindof understand.
(15:00):
You know, I'm somehow very fondof telling my patients in the
clinic like I care about yourpain.
I do, I care about it.
What I really care about is allthis systemic inflammation.
I care about your heart attackrisk, your infection risk over
time, and my job is to reallyhelp stamp out this inflammation
and help mitigate risks while Ido it.
(15:22):
So that's something where I getmy practice and my trial
practice a lot.
Dr. Michael Koren (15:29):
Yeah, and that's an important holistic
view.
And so interestingly andperhaps counterintuitively, even
though we may be focused on onequestion, when we do clinical
trials, we actually have tothink about patients
holistically.
So, as you point out, peoplethat have inflammatory
conditions such as rheumatoidarthritis, may be at mortality
(15:51):
risk from cardiovascular events,and by talking to them about
that, you're actually taking avery holistic view of the
patient.
Dr. Manish Jain (15:57):
Yeah, absolutely.
I think my passion in liferight why I feel like I was put
on this earth was to improve thelives of my immunocompromised
patients.
Ten years ago I think I hadkind of a myopic view of that.
Right, I was going to improvetheir lives within the context
of the medicines that I, as arheumatologist, classically
(16:18):
would prescribe.
But now my perspective is somuch different.
Right, I still am prescribingthose medicines and you know,
I'm getting their disease undertight control.
But I'm also thinking abouttheir BMI, I'm also thinking
about their lipids, I'm alsothinking about their vaccination
status.
I'm also thinking about, youknow, have they gotten up to
date on a malignancy screening?
(16:40):
So these are all ways that Ithink I'm convinced.
I don't think I'm convincedthat the trials have made me
into a better clinician.
Dr. Michael Koren (16:50):
Yeah, and that's very, very well said.
So I'm going to switch gears onyou a little bit, and I also
know that you're passionateabout physician education and in
fact, you're going to join mehere in Jacksonville in April to
do a physician training courseon how to become more effective
as a clinical trialist and, ofcourse, teaching doctors who may
(17:12):
not be that familiar with theconcept of GCP or Good Clinical
Practices what that means andthat that is one of the elements
of the skill set that a goodclinical trialist has the many
other elements that we get intoduring the course.
So just tell us a little bitabout how you got interested in
the physician training piece andmaybe some of your strategies
(17:34):
on how physicians learn best.
Dr. Manish Jain (17:37):
Yeah, absolutely I love teaching.
It's been a part of my careerfor quite some time.
So actually before I got reallybusy with clinical trials, I
participated quite a bit inresident education.
I was actually a programdirector for a transitional year
program.
That's a training stopping pointfor a future radiologist or
(17:58):
dermatologist and being able tolecture about rheumatic diseases
.
You know, I think sometimessome of my conditions kind of
are a little, they almost feel alittle mystical or confusing
even to medical trainees, and sodemystifying it.
You know, helping helping ourdocs understand how to recognize
(18:19):
and refer, maybe even take careof patients with our conditions
has always been a fulfillingpart of what I do.
It's really fun for me now tobring in the clinical trial
aspect into that and teach, youknow, training doctors about
well, okay, you're prescribingthis medicine, how did that
(18:40):
medicine come about?
Helping them understand how toread a study right, what are you
supposed to look at when you'reevaluating a study.
You know what are some of thequestions you should kind of
poke at a little bit when you'reevaluating a study.
So I'd say, being able to kindof educate trainees on the
(19:01):
clinical trial process and justhow to critically evaluate you
know data as it comes out Superfun, super fulfilling for me.
Dr. Michael Koren (19:09):
Yeah, that's.
A great point is that it may bea bit of a lost art, but
reading a technical journalpublication is something that
not all physicians areparticularly good at, and once
you have some clinical trialexperience you get much better
at that and it really enhancesyour understanding of the
(19:30):
particular project, thehypothesis that's being tested,
the therapeutic area and alsothe interface between your
patients and what they can getout of the latest and greatest
in that therapeutic area.
So I think we do spend a littlebit of time on how to read the
literature during our trainingprogram.
Dr. Manish Jain (19:49):
Yeah, absolutely it almost.
You know, when you get kind ofinvolved in this clinical trial
world, you really get this veryfoundational, fundamental,
in-depth understanding of thestudies and you know it's almost
like you, almost you startfollowing studies, like you
start following sports if you'rean avid sports fan.
You really know the ins andouts of them and you bring that
(20:13):
back into clinic on a day-to-daybasis and that's really fun is
being able to close that loopfor patients.
Dr. Michael Koren (20:20):
Yeah, absolutely.
And this next question mayreflect my bias but how do you
feel about this standard oftraining quote, unquote, and I
put that in big, big quoteswhere somebody says, okay, look
at this website, doctor, andlisten to it for 30 minutes and
then you're trained versus someof the experiential training
(20:44):
that we typically did back inresidency and fellowship and
what I believe is a great way totrain people after our quote,
formal training?
Dr. Manish Jain (20:55):
Yeah, so I I saw the evolution of medical
training and kind of the changeof what it's turned into now
during my medical training, youknow.
I mean we were kind of the from2006-2009, kind of the trailing
end of the last days of thegiants, where you know you had
the you know overnights in thehospital, 30 hour, uh, training
(21:19):
shifts and, and it wasn't to saythat it was all good.
Right, I mean there were somenegatives there, it was tired
and you know, but but really I,I like I'm, I'm really thankful
that I had that opportunity.
I don't think I'd be the samedoctor if I had dreamed uh if,
if I didn't have thatopportunity during during my
(21:40):
training, to have those long,long uh you know nights bleeding
into days and be able to carefor my patient with with that
continuity.
Dr. Michael Koren (21:54):
Yeah, no doubt we were just talking about
that earlier today that youknow, when I was training, being
on call every other night formonths at a time was not unusual
and we had shifts up to 36hours.
And that part of medicine froma training perspective has gone
away, and I think, probably forthe worst overall, although, to
your point, we don't need peoplenecessarily absolutely fatigued
(22:15):
making important decisions, butthere's ways to deal with that.
But getting to the more broadquestion, in clinical research,
what's the most effective way toteach other people to get up to
speed?
Dr. Manish Jain (22:35):
Yeah, I think it's got to be multimodal, and
so I think there's a role formodules and, you know,
standardized, formalizedtraining.
There's a role for, you know,lectures.
There's definitely that.
That's, I think, a corecomponent of the foundation.
There's a role for doing aswell.
You know, to be thatinvestigator, to perform the
assessments, to have that directpatient-facing contact as well,
is really important.
(22:56):
But I think there's that thirdpillar that has, for me, helped
make me the investigator I amtoday, and that's mentorship.
And it's sometimes hard to findmentorship within clinical
trials.
For me, that's been.
I think, one of the mostexciting things about being part
of a clinical trial networklike Flourish Research is that I
(23:19):
don't just have access toamazing patients and amazing
studies, but I have access toamazing mentors, and that has
just been really, reallyimportant and a big driver of my
growth over time.
Dr. Michael Koren (23:35):
Yeah, no doubt the concept of mentors has
been extraordinarily importantfor me and to your point, when
you're just looking at onlinemodules, you don't get that
sense, and there's very manysofter points of being effective
as a clinical physician and asa clinical trialist that you're
(23:58):
just not going to get other thanthrough experience and watching
how other people do things andfinding your niche.
You don't have to do exactlythe things the way your mentor
did, but at least you seedifferent styles and that
eventually helps you develop astyle that you get really
comfortable with and get reallygood at.
So I think that's superimportant.
So, Manish, this has been afabulous conversation.
(24:19):
Before we sign off, are thereany other major things you'd
like to share with the audiencewith regard to your career
experiences, your interfaces inclinical research?
Dr. Manish Jain (24:36):
Yeah, to me, I think it's just.
It's all about the synergy Ireally lean on.
You know the things that.
I hope make me a strongclinician, you know, I think,
directly carry over into beingan investigator.
There's definitely differencesas well, but to me I kind of see
it's more about the synergiesand similarities of the two.
And I guess the last otherclosing thought I'll leave you
(24:58):
with is it's super fun.
You know, I think we all Dr.
Koren, you and I both have somecolleagues that maybe aren't
having as much fun as they oughtto be practicing medicine,
right, I think we you know we wesee high rates of medical
burnout, just just as as anexample in our profession.
I really think to get toparticipate as an investigator
(25:19):
and kind of carry these dualroles, like you and I do, it's
really fulfilling and and Ithink we wake up just with a lot
of purpose and a lot ofexcitement and excitement and
ready to tackle the day, and forthat I'm truly thankful.
Dr. Michael Koren (25:32):
Yeah, and you alluded to this, but part of
our medical culture as oldschool physicians is that we do
clinical practice, research andteaching.
It's all part of this trilogythat are very, very important to
us, that fulfill us as as uh,as physicians, as physicians
that want to be a cut aboveother people, and, um, research
(25:56):
is a big part of that.
So, Manish, uh, yeah, this hasbeen a great interview and I
just want to say that we'll havesome show notes that give
people information about howthey may want to participate in
our training session coming upat the University of North
Florida in April, and so weencourage people physicians this
(26:17):
is really physician-focused tolook into that and learn more
from folks like us and othermembers of our educational group
that will be talking about themany, many elements of clinical
research that you may want toget involved with or, if you've
been a little involved with, youmay want to make your skills
get to a higher level throughthis type of interaction.
So, again, I'm excited to workwith you at the University of
(26:38):
North Florida in April.
We'll have more information onthe show notes and thank you so
much for being part ofMedEvidence!
Dr. Manish Jain (26:45):
Thanks for having me Really appreciate it.
Announcer (26:47):
Thanks for joining the MedEvidence! podcast.
To learn more, head over toMedEvidence.
com or subscribe to our podcaston your favorite podcast
platform.
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