🕗 A "Healthy Look" at Clinical Trial Participation Ep. 279

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On this week's Monday Morning Minute, Dr. Michael Koren joins Kevin Geddings to answer the question "can I participate in clinical trials even if I'm not sick?" They discuss how having "healthy participants" is critical for some clinical trials. They look at a current study that examines how the body processes oral statin medications and if those with kidney disease process medicine in a different way than those with healthy livers.

Koren's Key Takeaways:

• People without disease can be essential to the clinical trial process
• Statins are still effective, even if pharmaceutical marketing has slowed
• Joining a clinical trial as a low-risk "health participant" is a great way to learn about the process

Be a part of advancing science by participating in clinical research.

Have a question for Dr. Koren? Email him at [e-mail]

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Music: Storyblocks - Corporate Inspired

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Episode Transcript

Announcer (00:00):
Welcome to the MedEvidence! Monday Minute radio
show hosted by Kevin Geddingsof WSOS St Augustine Radio and
powered by ENCORE Research Group.
Each Monday morning, Dr.
Michael Koren calls in to bringyou the latest medical updates
with insightful discussions.
MedEvidence! is where we helpyou navigate the real truth
behind medical research, withboth a clinical and research

(00:20):
perspective.
So sit back, relax and getready to learn about the truth
behind the data in medicine andhealthcare.
This is MedEvidence!

Kevin Geddings (00:30):
Dr.
Michael Koren is with us.
He is a medical doctor,cardiologist, research scientist
, heads up the show at ENCOREResearch Group They have
offices right here in St.
Augustine at the WhetstoneBuilding near UF Flagler
Hospital and they are, of course, conducting leading-edge
clinical trials and medicalresearch and we have the
opportunity to participate righthere locally and I think a lot
of our listeners who are drivingaround and who have listened to

(00:52):
you for a couple of years now,on Monday mornings typically
feel like, well, I'm not sick.
I'm not suffering from diabetesor heart disease or something
like that, and so I can'tparticipate.
But they would be wrong,wouldn't they?

Dr. Michael Koren (01:06):
Yeah, part of our process is to understand
how certain things work.
In "healthy people" or peoplethat maybe have one small issue
that is of particular scientificinterest.
So, for example, we're doingsomething right now where we're
comparing the way a medicationworks, given once in somebody

(01:29):
who's pretty much healthy, andwe're comparing that with how
that same medicine will work forpeople that have some problems
with their kidneys.
So, interestingly, the waythese things work is that we do
a matched control typeexperiment that's the technical
term for it and really what thatmeans is that if we find

(01:50):
somebody that has kidneyproblems and we want to use this
medication, we want to findsomebody very similar to that
person in terms of age and theirbody size, but without the
kidney problem.
And very specifically, rightnow we're looking at this really
interesting new cholesteroldrug that will have some of the
similar impact of the injectabledrugs Repatha and and Praluent,

(02:14):
but it'll do that in a pillform and we're looking at how
that is eliminated from the bodyin patients that have kidney
disease.
And when I compare that directlywith the same type of patient,
that pretty much is fine.
So, for example, if you are ahealthy person and you're on a

(02:34):
statin drug and you want to justsee what it's like to be part
of research with super low risk,in these cases, for these type
of studies we typicallycompensate patients pretty
nicely and people learn theprocess.
So they learn a lot about theparticular area that we're
studying.
They get a chance to interactwith me and the others and get a

(02:57):
lot of questions answered andwe're often able to help people
clear up whatever questions theyhave in medicine.
And probably most interestingintellectually is they see how
this whole process works.

Kevin Geddings (03:11):
Yeah, they get a sense of what clinical trials
are all about and maybe losesome suspicions they may have or
, better, have a littleincreased confidence in how
medicines are brought to market,right, Absolutely.

Dr. Michael Koren (03:24):
And again, those are lessons will
eventually get applied for mostof us.
And it's interesting, you know,when there's a doctor at the
table, they'll typically ask mea lot of questions and it's my
opportunity to kind of help themwith some inaccurate
preconceived notions.
And people get that same sortof opportunity when they're
involved in a research studyRight.

(03:45):
So, for example, we were havinga discussion about statins last
night and people are asking mewell, do we want to replace
statins?
And the truth is that statinshave an amazing track record.
We don't always hear thatbecause the drugs are not being
actively marketed anymore.
They're just generic drugs andwe forget how incredible these

(04:07):
drugs were in terms ofpreventing heart attacks and
strokes and really being aninsurance policy for people.
So with the study that we'redoing right now, we look for
people who are in a statin andwe'll actually be doing a bunch
of safety tests.
So if there's any concernsabout how the statin is
interacting with your body,there's a great opportunity to
get more clarity on that andalso learn about the process of

(04:31):
moving other medicines forwardand how those medicines may
interact with the drugs you'retaking.

Kevin Geddings (04:37):
Well, once again , if you have any questions
about participating in someleading edge medical research
and once again you you have anyquestions about participating in
some leading-edge medicalresearch, and once again you can
be perfectly healthy in doingthat.
There are all sorts ofdifferent opportunities and you
can do it right here in St.
John's County with our officeshere in S t.
Augustine.
Go to EncoreDocs.
com.
That's spelled E-N-C-O-R-EEncoreDocs.
com.

(05:08):
Speaking of getting goodinformation, why don't we do a
little plug, Dr.
Koren, for the med evidencewebsite?
Med evidence.
com

Dr. Michael Koren (05:11):
Yeah, that's our platform to discuss the
truth behind the data and we runall of our educational sessions
through that.
There's some short formatpodcasts, maybe 10 minutes.
There are others that we call adeep dive, where you can learn
quite a bit about a specificarea.
For example, Dr.
Rothstein and I recently did afascinating podcast on chronic

(05:32):
lung disease and one of thethings that comes up all the
time is is that something thatyou may have that's been
undiagnosed?
This is particularly importantto people who are smokers or
former smokers.
They may have some subtleeffects of this, just like a
cough that seems to be chronic.
But when you go through ourpodcast you'll have a much

(05:53):
better sense for whether or notyou should be concerned.
Number one.
And number two if you're notsure, there's a process that you
can go through to learn moreabout it and of course, that's
where we do our screening forclinical research.
So just to remind folks is thatyou may get the first lead on
some medical issue throughMedEvidence, but you can follow
it up by giving us a call,coming in and having us do an

(06:15):
evaluation to see whether or notone you're eligible for the
research programs that we'redoing, but perhaps more
importantly, just get a betterunderstanding of where you stand
.

Kevin Geddings (06:24):
Well, once again go to the website MedEvidence.
com, MedEvidence.
com and participate in clinicaltrials and, perhaps you know,
earn a little bit of anhonorarium in the process you
know, get compensated for yourtime.
Go to encoredocs.
com.
Encoredocs.
com.
Or call the office here in St.
John's County in St.

(06:44):
Augustine at 904-730-0166.
That number again.
Punch it into your cell phone[phone].
Dr.
Koren, we hope you have a goodSt.
Patrick's Day parade orwherever you're going.
You're not going to a parade,but maybe a good St.
Patrick's Day right.

Dr. Michael Koren (07:01):
All right, take care.
Bye-bye.

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