Strengthening Commitment to Clinical
Research
The National Heart, Lung, and Blood
Institute's Specialized Centers of Research Program
Claude Lenfant, MD
(Published in the January 29, 2002, issue of Circulation)
The National Heart, Lung, and Blood Institute (NHLBI)
established its pioneering Specialized Centers of Research (SCOR) program 30
years ago to facilitate the translation of basic science research to clinical
practicea goal that is very much in keeping with our mission of
harnessing scientific endeavor to improve the health of the nation. The
Institute now funds SCOR programs in 14 scientific areas, comprising 69
individual awards.
As is the case with our other program mechanisms, we
continue to review, debate, and where necessary, amend our SCOR policies to
ensure that the program addresses public health needs and capitalizes on
scientific opportunities. The last major change in the SCOR program was made 8
years ago (see Lenfant C. The NHLBI centers program: the sun also rises.
Circulation. 1993;88:3). At that time, we sought to preserve and maintain the
"specialness" of these Institute-solicited programs by announcing that each
would "sunset" after 10 years unless a thorough evaluation of research needs
and opportunities uncovered extraordinarily compelling reasons to continue a
specific SCOR program. Since that time, old SCORs have ended and new ones have
been created to take their place.
Most recently, a couple of SCOR programs were
evaluated according to the terms of this "sunset" provision by
multidisciplinary teams of experts from the extramural community. The
evaluators were unanimous in their praise for the scientific productivity of
the SCORs. They were, however, equally uniform in their recognition that most
of the progress had occurred in the basic science arena, that little systematic
collaboration took place between basic and clinical researchers, and that scant
evidence of translation of basic findings to medical practice could be found.
Based on these observations, Institute staff undertook
a comprehensive review of the NHLBI SCOR mechanism, discussed its strengths and
weaknesses, and developed recommendations to enhance the clinical focus and
utility. The results of this review were presented to our Advisory Council at
its October 2001 meeting and were enthusiastically endorsed. The bottom line is
2-fold: the SCOR program must be continued; but, the SCOR program must be
changed.
Continuation of the SCOR program is essential if we
are to fulfill our mission as a health-oriented organization. The SCOR is
virtually the only mechanism we have available to focus multidisciplinary
talent on clinical problems. As the basic science community relies on the
program project mechanism, so the clinically oriented community needs the SCOR
if it is to move patient-oriented research to the limits of its frontiers. I
might add that the Institute''s investment in SCORs (6.6% of total NHLBI
research grant dollars during fiscal year 2000) is modest in comparison with
its investment in program projects (15.2%).
As noted above, however, the SCOR programs have
strayed somewhat from their original intent, and the clinical research
components have, in many cases, been accorded the status of stepchildren. We
need to refocus the SCORs on our vision of a research environment in which
clinical issues define and drive basic research, and basic research findings
are rapidly applied to clinical problems.
Accordingly, SCOR programs initiated in the
futurebe they brand-new programs or programs that have completed the
initial 10-year period and are being recompetedwill be restructured and
renamed Specialized Centers of Clinically Oriented Research or SCCOR. The
acronym is rooted in the original program, but with the additional "C" to
reflect the centrality of clinical investigation. Clinically oriented research
is defined as research conducted with human subjects with whom the investigator
interacts directly. Clinical investigations may include studies of patients
with the disease of interest or healthy volunteers. The principal elements of
the SCCOR program are the following:
For any given SCCOR grant, the number of successful
clinical subprojects must equal or exceed the number of basic science
subprojects. Core projects cannot be counted to fulfill this requirement.
The goals of the new SCCOR program require
collaboration among disciplines and across SCCOR components. Collaboration will
be enabled in several ways. For instance, SCCOR subprojects will continue to be
supported by both basic and clinical cores, which are expected to be essential
shared resources. SCCOR directors will be encouraged to establish links with
existing resources, including General Clinical Research Centers, the NHLBI
Programs in Genomic Applications, and NHLBI Clinical Research Networks, as
appropriate.
The SCCOR will offer a rich opportunity for
interdisciplinary educational experiences and skills development. To enhance
this opportunity, the Institute will make available additional funds to enable
each SCCOR applicant to compete for a Skills-Development Core. This Core is not
intended to function as a training grant but as a means of enhancing the
experience for young investigators who are involved in the SCCOR and providing
mentorship so that they can develop into independent investigators. It will not
be required, but guidelines will be available outlining the expectations and
requirements for investigators who are interested in adding it to their SCCOR
application.
The review process is key to the success of the new
SCCOR program. The Institute will take great care in assembling the Special
Emphasis Panel (SEP) to review each SCCOR program so that an adequate number of
reviewers with sufficient clinical expertise will participate. In addition,
pains will be taken to educate the members of the SEP about the primacy of a
clinically relevant focus within the SCCORs and the requirement that at least
half of the projects be viable clinical research.
To provide sufficient financial support for clinical
research, the budget cap for the new SCCOR programs will be increased. This may
necessitate fewer SCCOR awards, but the Institute and its advisors considered
this tradeoff worthwhile to achieve the goals of accelerating the pace at which
bench research is translated to the bedside.
The NHLBI and its Council are excited about the
prospects offered by the new SCCOR program and are looking forward to
strengthening existing research and forging new collaborations. But, there is
no question that the success of this venture is entirely dependent on the
dedication, creativity, and interest of the scientific community in achieving
these objectives. We hope the readership will join wholeheartedly in this
effort. More information on this program can be found in the
document, Specialized Centers of
Clinically Oriented Research (SCCOR)--Program Description, that was posted
in March 2002.
|