College of Medicine welcome to ask us anything
about clinical trials. I'm Scott Gilbert
clinical trials are a critical part of
the process of approving drugs
treatments and devices but you may want
to learn a little bit more about them
and that's why we're here today talking
with Terry Novchich, she's director of
with the clinical trials office here at
Penn State College of Medicine. Terry
thanks for being here. Thank you.
appreciate your time. Dr. Neil Thomas is
associate dean of clinical research at
the College of Medicine. Dr. Thomas,
thanks for being here. Thank you, Scott.
All right we're going to talk today
about again clinical trials and at any
point in time we welcome your questions
in your comments in the comment field
whether you're watching this video live
or on playback will get an answer for
you from these two. All right? Well, let's
start with how clinical trials fit into
that overall process. It can be a very
lengthy process to approve drugs, devices,
and treatments. Where do clinical trials
fit into that process? They are in fact a
lengthy process in fact there are
instances where it can be up to between
15 and 17 years for a particular drug or
device to get through all the approval
processes before we actually see it and
physicians are able to be able to
provide that care. So there are multiple
phases for particular types of trials.
And, I will let you address that. It really once the preclinical
work is done, it starts at the phase 1
trial which basically focuses on safety
Either in patients with the disease or
healthy volunteers. If it gets through
the safety process and about half of
the medications that go through phase
won't actually get to phase two then we
begin to look at efficacy how effective
it is in a patient population still
paying close attention to safety. If that
is successful then the large phase 3
trials are really the ones that you
think about with a large randomized
control trial where people will get a
medication or get a device in a large
scale usually across multiple
institutions across the country across
the world. And that's all extremely
important an necessary information for
the FDA to to issue approval of a drug.
You know, you mentioned even half of
those drugs don't make it to phase two
why is that? Oh it that there's this
very small percentage of potential drugs
that actually make it all the way
through.
A lot of times the safety profile
just isn't good enough. There are too
many side effects and before phase 1
trials are very small and a limited
number of patients and the dose of a
medication is escalated over the course
of the study. If they find that the drug
is not safe enough or has too many
adverse effect, then that will be
the end of the trial at I'll never move
forward. Now obviously a lot needs to
happen even before a drug or treatment
can make it to the clinical-trial phase
can you talk about that what happens in
the in that long period of time leading
up to clinical trials? Well, we do have
what we call the preclinical work you
know it first starts with somebody
having the idea of a particular compound
or particular treatment for an injury or
an illness so it takes again many years
to be able to develop those ideas and
get through that preclinical work to
then provide two truckloads of
information to the FDA to then be able
to want to move those into the realm of
human subject research. You're watching
Ask Us Anything About Clinical Trials
from Penn State Health and Penn State
College of Medicine. I'm Scott Gilbert
along with Terry Novchich and Dr. Neil
Thomas. We welcome your questions in the
comment field of this Facebook post and
we'll pass those along to them. Whether
you're watching this video live or if
you're watching on playback. We also
encourage you to share this video if you
find the information in it to be useful
You know, I tell you mentioned a bit
about the FDA and their involvement. I
know there are a lot of approvals
involved both at the FDA and right here
on the Hershey Campus that need to
happen throughout the process. Can you
guys tell me a bit about that? Right, we
have a human subject protection office
so there are administrative arm of what
we call the institutional review board
the IRB and our IRB mandated by
regulations from the FDA include
scientists, non-scientists, so for example
i'm a member of one of our IRB s and
more importantly we even have community
volunteer members who are able to give
us that different kind of a focus when
we review these clinical trials so they
go through a very robust review here
institutionally to determine is the
science really good is it a good fit for
our community and do we have the ability
to be able to do this study
do it well. Neal, how rigorous of a
process is that with the IRB? It's very
rigorous. Patient safety is always number
one and if the scientific integrity or
the question is a good enough then then
that gets wade into it as well. But the
IRB is the board that on our campus and
across all places around the world
ethics boards or IRB's review the
potential benefits and the potential
safeties and ways that before things are
moved forward. And then how do those
approvals interrelate with the approvals
needed from the FDA? Well they they are
really required before the any clinical
trial moves forward. So before even a
phase one trial can get started it
requires IRB approval at the institution
where subjects will be recruited or at
any institution where subjects are we
recruited. As the phases of the therapy
move forward, each protocol will be
reviewed by the IRB and that
determination will be made. So people
getting involved in a clinical trial may
wonder, well I don't know if I want to be
the first person to try this medication
but really a lot of careful steps have
been taken to ensure the safety before
that then right? There have been and of
course that's part of why we talk a lot
about healthy volunteers and many of
these early phase trials they are in
fact the trials conducted in healthy
volunteers so that's individuals without
the actual disease or condition and
there are just a key part to the
research process. Sure, and healthy
volunteers are the focus of our Penn
State Medical Minute. You can find that
online at PennStateHealthNews.org
that was just in this past week. We
encourage you to check that out. And also
while we're on here we want to tell you
that clinical trials will be the focus
of a TV show on this Thursday evening
April 27th on WHTM TV ABC-27, a special
show where you can get your questions
answered about clinical trials 7:30 p.m.
this thursday night so make sure you
check that out. Let's talk a bit more
about healthy volunteers because that's
an interesting part of the process. What
is the role of a healthy volunteer in
the typical clinical trial? Well it there
are different aspects of healthy
volunteer research. Some of it doesn't
relate at all to medications or
treatments really
understanding disease. So our Heart and
Vascular Institute in the College of
Medicine has a large number of trials
where healthy volunteers are recruited
and have certain stimuli applied to them
and to determine the body's response.
That's incredibly important to
understand the mechanism of disease so
we can develop these targets. Healthy
volunteers also can be part of the early
phase clinical trials, particularly phase
1 trials. I always tell the story as a
medical student I was part of a phase 1
trial and medication that's now FDA
approved and I spent a couple
nights in a research center having my
blood drawn and receiving this
medication. So it is something that is
necessary to move forward and sometimes
for medications, healthy volunteers need
to be tested before patients with
disease. Must be neat knowing that you
had a small part in that process of
allowing that drug to be put on
the market. It makes it easier for me to
support clinical research and especially
healthy volunteer research. Terry talked
to me about some of the reasons that
people who have a given illness or
condition should think about looking for
the available clinical trials out there.
What are the benefits to them? Well in
many instances it provides the ability
for an individual to receive a
particular treatment or of a therapy
that they may not otherwise have
available to them. It allows that
individual to have a really should have
a robust discussion with their care
provider to say, you know, what are the
options out there for me with my
particular condition and to be able to
be a part of that. Now there is a control
group in these studies, right? So I mean,
that there's a chance that that the
individuals enrolling will get the
actual treatment some may get placebo. In
in the later phase studies some phase 2
in all the phase through most phase 3
studies there is a placebo group and so
the only way to scientifically tell if a
medication or therapy has in effect is
to compare it to what is standard of
care. So I think it's important to
realize that patients with disease will
receive standard of care they won't
receive nothing if there is a medication
or a treatment that is effective for
that disease. And the placebo will be in
addition to what they would normally
receive. A very important point. You're
watching Ask Us Anything About... Clinical
Trials
from Penn State Health and Penn State
College of Medicine. I'm standing
alongside Terry Novchich and Dr. Neil
Thomas and they welcome your questions
here in the comment field below this
video. Whether you're watching it live or
if you're watching on playback, will make
sure we track them down and get an
answer for you. I would think another
perhaps less tangible but still very
important reason to be a part of a
clinical trial, if you have a given
condition would be knowing the good you
can do for patients with that condition
in the future. Right? That is correct
it may be that at the current time that
you are taking part in a clinical trial
it may not have benefit to you but know
that you are actually contributing to
perhaps certainly the scientific
knowledge and the body of work for that
particular condition that down the road
may benefit others. Absolutely! And I
think it's important when you ask
unfortunately only one percent of the
U.S. population participates in clinical
trials but when you ask people who have
participated why they did, many times it
was too to further understanding of a
disease and to develop treatments for
the future. Not not for them. Talk to me a
little bit about Study Finder. That's a
website www.StudyFnder.psu.edu That's an
important link to remember we encourage
everybody to check that out because that
will tell you about all the clinical
trials available, here at the Medical
Center. Right? Yes, go ahead. So a Study
finder we are lucky enough to have
received an award from NIIH called the Clinical and
Translational Science Award. We are 1 of 64
institutions across the country that has
those awards and it's an infrastructure
award and through that award we were
able to borrow technology from the
University of Minnesota to develop phase
one of study finder which we presently
have where it will draw information
about our phase 2 and phase 3 clinical
trials. What we've worked on since then
is phase two a study finder which will
be live as of June 1st and that will be
all of our clinical research including
healthy volunteers survey studies really
anything that requires IRB approval that
is recruiting human subjects will be one
place and that will be www.StudyFinder.psu.edu
Sounds like a great resource
something we should all check out then.
StudyFinder.psu.edu Well, I really want
to thank both of you for being here
today to talk about this and I guess
when we think about the future
what happens after a clinical trial.
There is one more question I want to ask
about. What does happen and let's say, in
that four phase process, let's say a drug
or a treatment makes it through all four
phases. What happens then? Well, then at
that point depending on what it is the
drug or device then becomes available.
You know, out in the for the providers to
to be able to prescribe. There are some
instances we are seeing a little more of
the FDA requiring what we call phase for
follow-up studies and that is again, from
a safety perspective, to be able to
collect more and more data when you get
out to conducting are now providing this
medication or treatment to a large
larger group of patients than just those
who are in the trials they want more
information so we're seeing more that as
well. Great anything else you guys want to
cover we didn't touch on? No, I think we
we hit all the high points. Yeah well,
thank you both very much. We have Terry Novchich
she's the director of the
clinical trials office here at Penn
State College of Medicine. We have
Dr. Neil Thomas, the associate dean of
clinical research here at the College.
they both join me for this edition of
ask us anything about. Even if you watch
this video on playback, please do add
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About... Clinical Trials from Penn State
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