Strengthening Commitment to Clinical Research
The National Heart, Lung, and Blood Institute’s Specialized Centers of Research Program
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 practice—a 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 future—be they brand-new programs or programs that have completed the initial 10-year period and are being recompeted—will 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.
The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.