Sangeeta Bhargava: What I’m going to do today
is give you a brief overview of the NEI clinical research.
I am the sole representative of my program here today.
My other two distinguished and esteemed colleagues, Don
Everett and Maryann Redford,
have conflicts and they are attending DSMC meetings
for their respective trials.
The DSMC meetings are an integral part of our job,
and we do it on a regular basis as NEI representatives to
give the right amount of oversight. In
the past few Council rounds, you have heard a lot of
basic program concerning the retina, the
cornea, the lens, glaucoma and low vision. And
what I want to emphasize in this extramural
program matrix is that the collaborative
clinical research program crosses over all of them.
So that means we have clinical
studies as well as trials from all these areas,
which is the retina, cornea, lens, glaucoma and low vision.
Our main goals of our clinical research program
is to test new agents, technologies and
other interventions for the prevention, diagnosis
and treatment of eye diseases and/or improve vision-related
quality of life. We
fund applications that conduct population-based research to describe
the prevalence of eye diseases across the life span
and within and among divergent demographic groups.
We have applications that conduct studies to identify
risk factors for
the development, persistence and progression of eye diseases,
and applications that do secondary data
analysis using existing database resources.
We also have a lot of grants in our portfolio
which look to conduct system-level health service
research to improve vision health and/or reduce
health disparities.
And we also have applications that are looking to develop new
statistical methodology
or tools appropriate for analyzing vision health data.
And lastly, applications that develop new approaches
to conducting clinical research
studies, including those that capitalize on point of
care as well as electronic medical records.
The way we do our clinical trials is through two
mechanisms: One is through Cooperative Agreements, and
earlier in the morning you have heard of U01s and U24s.
The activity code that we use in the clinical
trials is the UG1, and these are for our bigger trials.
And I just want to remind the Council members
that the Cooperative Agreement is a support mechanism that
NIH frequently uses for high-priority research areas
that require a lot of involvement from NIH staff
which is much more than what a typical
research program or R grant would be.
We also do clinical studies
and some of the epidemiology studies using the R mechanisms,
and these are for our
simpler clinical and epi studies using the R01.
We have the secondary data
analysis, for which we use the R21, and
this is one of our more popular programs in our portfolio.
We also do a lot of clinical study planning grants,
and those are the R34 grants. In the next couple of slides
I’m going to show you
a few examples of our clinical trials and epi studies
that we have done over time.
But I also want to remind
the Council members that before we do any study
or we start any clinical trial
or epi, we always bring it to the Council
for discussion and input before any trial is started.
So some of our epi studies—and these are just examples
to give you a flavor of the
kind of studies we have done over time.
We have done a glaucoma evaluation study,
so the African descent. For our demographic population we’ve done
the CHES study, the Chinese Health Eye Study.
We’ve done the Latino Eye
Study. We have looked at some of the infectious disease.
We had done for the AIDS complication, the LSOCA study.
We have done for uveitis, we’ve done the uveitis
follow-up study.
We’ve also looked into epi studies in children,
and that has been the VIP study and the AACDAT study.
So we’ve done quite a few studies, and this is just
to give you a flavor
of some of the epi studies we’ve done. Besides the epi
studies, we’ve also looked into the clinical trials— and
these are again some of examples of clinical trials.
We have looked into clinical trials using intervention,
some that target
vision diseases—for example, the CATT study,
which was to target AMD. We have the SCORE2,
which was to do the retinal vein occlusion.
We have studies ongoing
that are looking at some of the
infectious diseases like the herpes zoster. We have
trials going on in the uveitis field—the MUST is one of them.
We have studies that we
have done for early treatment of ROP,
the ETROP as well as the EROP.
We have studies done for uveitis, as I mentioned.
One of them is the FAST.
And what I really want to bring out is that as the
basic research is moving along,
as the advances in basic research come along,
we also have more clinical trials in that area.
For example, we just recently
funded some clinical trials using stem-cell
therapy as well as gene therapy, and those are examples—the
LHON study, the TRUST as well as the CLEX study.
Earlier in the morning, Dr.
Sieving alluded to the networks, and these are one of our
success stories in our portfolio of the CCR Networks.
We have two networks
that we have been involved with in the past
few years. One of them is the PEDIG—that
is, the Pediatric Eye Diseases Investigator Group.
And the other one is the Diabetic Retinopathy
Clinical Research Network. One thing Dr.
Sieving also alluded to in
the morning session—the difference between a network
as well as clinical trials and epi studies that
I just showed you before. The trial is basically one protocol;
but with the networks, because they have
so many clinical sites involved, so many physicians
involved, they are doing multiple protocols at one time.
A couple of things that I want to point out about our networks
that is very unique
across the NIH is that they are open network.
That means pretty much anyone can join in to do a protocol.
They can do two protocols if they want to.
Or if they don’t want to do a protocol,
they don’t need to do it. And as Dr.
Sieving already also pointed out, most of the physicians
on the participating sites are 3/4 community-based
providers and 1/4 academic institution.
Both the networks have been an example
of private/public partnerships. And last
but not least, I want to point out that they have been very collaborative in terms
of the other NIH Institutes.
We do collaborate with the National Institute
of Child Health and Human Diseases, NICHD for PEDIG,
and for DRCR.net there is ongoing collaboration with NIDDK
as well as co-funding by the same Institute. Thank you.