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April 23, 2025 • 16 mins

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Dr. Michael Koren sits down with Dr. Murali Ramaswamy to explore the concept of Research as a Care Option. They compare this with the misconception of research as a treatment option to reveal how clinical trials provide structured environments that often lead to better health outcomes regardless of the specific intervention. They debunk the idea that clinical trials provide treatment, due to the randomized nature of trials, but discuss the numerous health benefits seen by patients who enter a clinical trial - even those who get a placebo!

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Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.com

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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 bycardiologist and top medical
researcher, dr Michael Koren.

Dr. Michael Koren (00:11):
Hello, I'm Dr .
Michael Koren, the executiveeditor of MedEvidence!, and I'm
joined today by Dr.
Murali Ramaswamy, who is aclinical trial professional like
myself, who is really fabulousin the pulmonary area and has
developed a really interestingbusiness concept to help doctors
get more involved in research,and is a like-minded physician

(00:34):
who's going to talk to me aboutclinical research and this
really important concept ofresearch as a care option.
It's funny we were justchatting before we got on the
podcast and he used this term,which I love, Murali I love that
term, and we like to make thedistinction of research as a
care option versus research as atreatment option, and so let's

(00:59):
dig into that together and helppeople understand what we mean
by that quote subtle difference,which is really an important
difference.
So please go ahead andintroduce yourself to our
listeners and viewers and letthem know who you are, what your
background is and how you gotinvolved in clinical research.

Dr. Murali Ramaswamy (01:15):
Yeah, hi, my name is Murali Ramaswamy and
I'm in Greensboro, NorthCarolina.
I work at Cone Health and Idirect the pulmonary fibrosis
program there, but I'm also CEOand co-founder of Pulmonix
Clinical Trials.
I've been doing this for 10years now and my specific
interest on the clinical side ispulmonary fibrosis, as I

(01:37):
mentioned.
But I really love clinicaltrials because of the fact it's
a care option for patients, butalso because it helps really
transform the clinical care incommunities in ways that
communities that don't haveresearch or health systems that
do not have research are notable to, and that's really my
passion in my career.

Dr. Michael Koren (01:59):
Yeah, so I'm going to unpack some of those
statements for everybody who'slistening in
Absolutely.
And as I think you know the concept of
MedE vidence!, You have twoknowledgeable physicians talking
about a topic and people gleaninsights from that discussion
and it's a very open and honestdiscussion where we don't
particularly have an agenda, buteverybody can then apply that

(02:20):
learning to their own individualcircumstances.
So when you talk about researchas a care option, we like to
make the distinction.
It's not research as atreatment option, for the very
basic reason that we don't knowwhat treatment you're on.
However, we do know thatthere'll be a caring environment

(02:40):
and that people that getinvolved in research are more
likely to do other thingscorrectly in terms of their
healthcare.
Plus, they have resources whothey can talk to about the
questions that arise.
So I know what's been yourexperience, or you can give us
an anecdote or two, that kind ofshow that particular element of
what we do as researchers.

Dr. Murali Ramaswamy (03:00):
Yeah, thank you.
This is a really, really keypoint.
One of the first things that Ilearned in my journey as a
clinical trialist was thisconcept of therapeutic
misconception, and oftentimes Iwould meet patients or I would
meet other colleagues in myspecialty or other specialties
who would say well, we'retreating this patient with a

(03:21):
clinical trial, or you can getthis treatment ahead of time,
before it's approved.
And I found that reallypuzzling and I actually found it
a little unethical too, becauseit's one, it's not approved.
Two, you could be gettingplacebo.
Three, the probability of harmis actually higher than an

(03:41):
approved drug, so there is riskinvolved, and so I really felt
like this is not a treatment.
On the other hand, when somebodygets consented correctly and
enrolls in a clinical trialprogram, they get the attention
of physicians, they get theattention of care coordinators,
they're getting blood work,they're getting pulmonary

(04:01):
function tests.
In my case, they get EKG scans.
All those things can bevaluable to a patient in terms
of their health information, andby keeping these follow-ups
they have a certain level ofattention and there's also
information that is garneredthat can in turn, help their

(04:22):
care.
So that's one piece where Ithink clinical trial
participation can really helpthese patients.
The second piece, of course, isthe main motivation is to
advance science, and so when wetalk to our patients, we're
always very clear cut as to themotivations as to why they
should be in a trial, regardlessof the phase.

(04:43):
Certainly, later the phase,phase three, they can
potentially have sometherapeutic misconception, but
earlier the phase, for sure,they're there because they want
to develop science and maybe getsome data for themselves, and
so that's why I believe researchis a care option and not a
treatment option.
Thank you for that.

(05:03):
That's an important distinction.

Dr. Michael Koren (05:04):
So I agree with about 90% of what you said.
There's 10% that I don't agreewith and let me explain why.
Okay, so you're absolutelyright is that we don't want to
call it a treatment option,because we just don't know what
treatment you're on.
In many cases for anyplacebo-controlled study, we
just don't know.
So we never want to give thatmisconception.

(05:26):
Therapeutic misconception is animportant concept because we
don't know what you're on,It could be placebo, but it
doesn't mean that we don'tpromote the core values of that
particular area.
So, for example, as me as acardiologist, when somebody is
doing a cholesterol programthat's using a novel agent to
lower their triglycerides ortheir lipoprotein layer of

(05:48):
cholesterol, I'm stillreinforcing that they should
take their statin drug and aspart of that, we are reinforcing
their treatment while we'restudying a specific nuance of
the treatment.
And just that person being inthe trial and getting that
reinforcement is actuallysomething that lowers their risk

(06:08):
.
You said that the risk isincreased, but I actually think
it's probably lower for tworeasons.
One is because we'rereinforcing good behaviors.
But the other thing is thatwhen you're in a clinical trial,
you're discovering side effectsearlier.
So even if when you use anapproved product, you can have a
side effect for months andmonths and months and months and

(06:29):
no one's really looking at itto cut off the period of
exposure to that risk or thatside effect, whereas in a
clinical trial we find it rightaway.
Not only do we find it rightaway for the individual patient,
but we're collecting data allover the world, so we're finding
it collectively for allpatients.
So if there's a subtle sideeffect that somebody should be

(06:50):
looking out for, we have asystem to identify that, and
I'll make one other point.
One other observation is thatsome approved drugs did not
undergo the scrutiny of thecurrent clinical trial
environment.
So one of the things we like tojoke about in cardiology is
that we have a 200-year-old drugin digoxin.

Dr. Murali Ramaswamy (07:11):
Absolutely

Dr. Michael Koren (07:12):
Never really went through clinical research.
That is actually a prettydangerous drug if you don't use
it correctly.
And so we actually have muchmore safety information about
current drugs than older drugs,and a lot of current drugs or
even drugs in clinical researchare actually less likely to have
side effects compared to stuffthat's been on the market for a

(07:34):
long time.
So a lot of nuances in that,just to point that out.

Dr. Murali Ramaswamy (07:37):
Yeah, I agree with you on that.
I think that's about riskcontrol and I think clinical
trials absolutely gives atighter risk control with
monitoring.
And when I talk to patients,that's one of the things I
emphasize.
When they're worried about risk, I talk to them about how risk
is controlled, not only throughinclusion-exclusion criteria but

(07:57):
the amount of follow-up that'sinvolved, the amount of safety
laboratory tests that are beingchecked.
So they do feel reassured bythat.

Dr. Michael Koren (08:08):
Right, so I want your opinion on this.
This is a little bitcontroversial in our area and I
love your opinion on this.
So there are more and morepeople that are talking about
the fact that when folks enrollin clinical trial patients
enroll in clinical trialsthey're less likely to have
overall medical complications,and managed care organizations

(08:31):
are starting to look at clinicaltrials as a way of reducing
re-hospitalizations, for example, for people with heart failure,
regardless of what treatmentthey're on.
Or they find that people havebetter diabetic control when
they're in clinical trials, evenif it's a blood pressure trial,
that people just tend to complywith the things they should
comply with better, and thatactually reduces costs to the

(08:52):
system and also improves overallcare, even if the trial is not
in the area that they're lookingto reduce costs in.
So I was just curious to seewhat you thought about that
concept.

Dr. Murali Ramaswamy (09:05):
Yeah, thank you.
So our health system is movingtowards value-based care and
this conversation has come up inthe last year or so and I've
struggled to find data behindthat.
But I'll be honest, I do nothave data for it, but I've heard
this conversation come up andI've also heard that when health

(09:25):
systems have integratedresearch and they go for
contracting with insurancecompanies, it's better because
insurance companies love to seeclinical trials.
But whether the clinical trialis overall beneficial in the
types of outcomes you arementioning, I personally do not
know.

Dr. Michael Koren (09:44):
Yeah, I love that answer.

Dr. Murali Ramaswamy (09:46):
I've heard this conversation.
I've tried to look up PubMedand Google and not really come
across anything.
But, I've also heard this frommy mentors in clinical trials
that this to be true.

Dr. Michael Koren (09:58):
Yeah, that notion is out there and it's
hard to find data to support itexactly.
I don't think it's anunreasonable notion, but I think
it should be looked at moreformally before we start
spouting this as a reason forsystems to necessarily push
clinical trials.
But I do think it's areasonable hypothesis and I

(10:20):
think physicians like you canhelp us all figure this out and
also look at the size of theeffect, which is going to be
important.
We do know that in general,when people are involved in
clinical trials, they tend tohave fewer complications than
would be predicted based ontheir perceived risk going into
the trial.
So one of my mentors, a famouscardiologist named Eugene

(10:44):
Braunwald, would equip that.
What he wanted to be when hegrew up was a control patient in
a clinical trial, becausepeople seem to just do better
when they're in clinicalresearch.
So that was another way ofsaying that and it's a notion
that we believe in, that we havesome data to support it, but,
to your point, it's still alittle speculative.

Dr. Murali Ramaswamy (11:06):
Yeah, I would concur.

Dr. Michael Koren (11:07):
Yeah, and then the kind of final thing I
wanted to touch on during thetime we have together is a
little bit about your businessmodel, and so why don't you help
people understand, because Ithink it's kind of a neat little
business model that peopleshould be aware of.

Dr. Murali Ramaswamy (11:21):
Yeah, thanks for that question.
So from a business perspective,the niche that we would fall
under is what today is commonlycalled integrated research
organization.
Obviously, that term is verynew relative to how long we've
been doing research.
So our business value prop, ifyou will, would be that on one

(11:46):
side you have clinical trialsites that are agile, that have
good domain expertise in runningbusiness has good margins,
they're efficient, theyunderstand GCP.

Dr. Michael Koren (12:01):
And that's good clinical practices for
people out there.
That's the.
FDA rules on how you conductresearch.
Sorry to interrupt you,

Dr. Murali Ramaswamy (12:07):
Yeah no, that's fine, but I think their
weakness is being able tointegrate research as a care,
because they're not part ofhealth systems, they're not part
of clinics in general, and sothat element as a physician, to
me that element is reallycritical in being able to

(12:29):
integrate research into the careplan.
So on the other side are thebig health systems that are
bogged down by bureaucracy andthey're very inefficient.
They can be risk averse forexample, delayed startup times.
These things can really impedeefficient research.

(12:51):
They also add to the cost ofdrug development and I believe
somebody like us who'sintegrated with the health
system and who is independentcan bring that efficiency, that
somebody who is like a privatetrial site and can bring that
efficiency into the healthsystem and be able to execute

(13:13):
trials and at the same time takeaway financial risk from the
health system.
But obviously research has goodregulatory oversight from IRBs
and FDA and the sponsors, sorisk is controlled for the
health system.
So that's sort of a value propand that's the sort of niche
that we occupy in providingvalue for the health system.

(13:36):
And the health system sees ourbenefits in two ways.
Obviously, the direct cost whenwe use their services.
That's very tangible.
But the biggest intangiblebenefit has been our presence
has changed the face of ourclinic, the pulmonary clinic,
for example.

(13:56):
When I started with pulmonaryfibrosis 10 years ago, only 1%
of the entire pulmonary clinicwas pulmonary fibrosis.
In the last 10 years, thevolume of pulmonary fibrosis
patients, without any marketing,has grown on an average 24%
each year year over year for thelast 10 years.
Pulmonary fibrosis is now 7% ofour pulmonary clinic.

(14:18):
Patients don't go to otherhealth systems.
Nearby is Duke, Wake Forest,Chapel Hill.
They stay in the community.
Occasionally we get patientsfrom you know, out of our
community as well community.
Uh, and likewise, one of mycolleagues is doing pulmonary
hypertension work.
Another one is doing some lungcancer screening work.
They've all seen explosivegrowths in their clinic.

(14:40):
Uh, just by the mere presenceof research and uh, yeah, we are
recognized as a center ofexcellence for pulmonary
fibrosis.
So there's, those are the kindsof benefits a health system is
able to derive, and I believethe health systems, because they
have to focus a lot on CMS andtaking care of patients, might

(15:02):
not have the core competency todo research well.

Dr. Michael Koren (15:06):
Understood.
How does your day-to-daybreakdown work between research
and clinical practice?

Dr. Murali Ramaswamy (15:12):
Yeah, that's a great question.
So right now I'm like 25%towards research, both as an
investigator and as anadministrator, and that risk is
on my own and I would say thatI'm really happy doing that.
But that time is not enough.
I probably have to scale myclinical down by another 25% at
this point.

Dr. Michael Koren (15:34):
Yeah, yeah, I've learned that over my career
that as you get more involvedin research, it becomes
something that you really haveto dedicate time to, to get to
the next level, the next level,the next level and finally, I
love your logo.
Who designed that?

Dr. Murali Ramaswamy (15:47):
Oh, it was my ex-brother-in-law in
Minneapolis, but he's reallygood.

Dr. Michael Koren (15:54):
We might have to steal his talents.
That's a pretty cool logo.

Dr. Murali Ramaswamy (15:57):
I'll make the introduction.

Dr. Michael Koren (15:58):
All right, Sounds great.
Dr.
Ramaswamy, thank you forjoining us in MedEvidence.
I enjoyed speaking with you andI hear we'll have some time
together here in Jacksonville inthe near future to talk some
more.
So thank you for enlighteningour listeners and viewers and
best of luck in your business.

Dr. Murali Ramaswamy (16:14):
Absolutely Looking forward to meeting you
and spending time with you.
Thank you, Dr.
Koren.

Announcer (16:20):
Thanks for joining the MedEvidence! podcast.
To learn more, head over toMedEvidence.
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