| Over the years, the National Institutes of Health has been criticized
for favoring basic biomedical research in its funding decisions, to the
detriment of proposals for clinically-oriented research. In 1995 a special
panel was appointed by Harold Varmus, Director of NIH, to study this widespread
perception, and to make recommendations about how to remedy the disparity
if it was found to exist.
In December, 1997, the panel submitted its report
and recommendations, which have now resulted in several new grant initiatives.
While the panel did not agree that clinical research was disproportionately
underfunded, it did recommend mandating more balanced composition of review
groups and new funding to train clinicians to do research.
The working definition of "clinical research" used by the panel was
in three parts:
(a) Patient-oriented research. Research conducted with human
subjects (or on material of human origin such as tissues, specimens and
cognitive phenomena) for which an investigator (or colleague) directly
interacts with human subjects. This area of research includes:
-
Mechanisms of human disease
-
Therapeutic interventions
-
Clinical trials.
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Development of new technologies
(b) Epidemiologic and behavioral studies
(c) Outcomes research and health services research.
Excluded from this definition are in vitro studies that utilize human tissues
but do not deal directly with patients. In other words, clinical or patient-oriented
research is research in which it is necessary to know the identity of the
patients from whom the cells or tissues under study are derived.
Using this definition, the panel indexed all competing awards for FY
1996 according to the use of human subjects, classification as clinical
research and whether they fall into the subset of clinical trials. The
table below summarizes this data.
| Category |
# of Projects |
Total dollars |
| All Competing Projects |
10,493 |
$2,361,434,220 |
| Human Subjects |
3,665 (35%) |
$1,139,061,717 (48%) |
| Clinical Research |
2,795 (27%) |
$905,852,246 (38%) |
| Clinical Trials |
518 (5%) |
$313,435,513 (13%) |
The panel also reported that the ratio of M.D. to Ph.D. applicants for
NIH support has progressively fallen over the past thirty years even though
success rates for the two types of applicants are similar. Importantly,
the absolute number of M.D. applicants has fallen further in the past three
years. Furthermore, M.D.s who fail to achieve fundable priority scores
from study sections following their initial applications are less likely
to reapply than Ph.Ds. The panel concluded that this represents a dispirited
attitude among M.D. faculty members that bodes ill for the future of academic
medicine and the public's health.
PANEL RECOMMENDATIONS
The panel made these ten recommendations:
The NIH should continue to monitor and track the percentage of NIH
resources devoted to clinical research and report these results annually.
The NIH must ensure fair and effective reviews of extramural grant applications
for support of clinical research: panels that review clinical research
(a) must include experienced clinical investigators and (b) at least 30-50%
of the applications reviewed by these panels must be for clinical research.
The NIH should initiate training programs that will enhance the attractiveness
of careers in clinical research to medical students.
The NIH should improve the quality of training for clinical researchers
by requiring grantee organizations to provide formal training experiences
in clinical research and careful mentoring by experienced clinical investigators.
The NIH should initiate substantial new support mechanisms for young and
mid-term clinical investigators.
A loan repayment program for clinical investigators should be instituted.
The scope of the General Clinical Research Centers should be broadened
to enhance their leadership role in clinical research and research training
and NIH should significantly increase its financial support of these centers.
The NIH should continue to improve the quality of clinical research and
strengthen research management in the Warren Grant Magnuson Clinical Center
(CC) and extend the availability of its resources and expertise, as well
as those of the Institutes and Centers (ICs), to extramural investigators.
The NIH should sustain a productive dialogue on enhancing clinical research
with its partners: the academic health centers, private foundations, and
the pharmaceutical and managed health care industries.
The NIH should expand efforts to educate the public about the crucial importance
of clinical research for the future health of the nation.
NEW GRANT INITIATIVES
In response to the panel's recommendations, NIH has announced the availability
of several new "K"
award programs. These programs include:
* Mentored Patient-Oriented Research Career Development Awards (K23,
Grant Announcement PA-98-052) The purpose of the Mentored Patient-oriented
Research Career Development Award (K23) is to support the career development
of investigators who have made a commitment to focus their research endeavors
on patient-oriented research. This mechanism provides support for a period
of supervised study and research for clinically trained professionals who
have the potential to develop into productive, clinical investigators focussing
on patient-oriented research.
* Midcareer Investigator Award In Patient- Oriented Research (K24, Grant
Announcement PA-98-053) The purpose of the Midcareer Investigator Award
in Patient-Oriented Research (K24) is to provide support for clinicians
to allow them protected time to devote to patient-oriented research and
to act as mentors for beginning clinical investigators. The target candidates
are outstanding clinical scientists engaged in patient-oriented research
who are within 15 years of their specialty training, who can demonstrate
the need for a period of intensive research focus as a means of enhancing
their clinical research careers, and who are committed to mentoring the
next generation of clinical investigators focussing on patient-oriented
research. The award is intended to further the research and mentoring endeavors
of outstanding patient-oriented investigators, enable them to expand their
potential to make significant contributions to their field of patient-oriented
research, and to act as mentors for beginning clinicians.
* New Clinical Associate Physician Award Guidelines (CAP) - The National
Center for Research Resources has consolidated the three career development
awards issued as competitive supplements to funded General Clinical Research
Centers into one Clinical Associate Physician (CAP) award. No new applications
for the Minority Clinical Associate Physician (MCAP) and Clinical Research
Scholar (CRS) will be accepted.
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