Clinical Research Skills-Development: A New Approach

Claude Lenfant, M.D.

We at the National Heart, Lung, and Blood Institute (NHLBI) are committed to improving the nation's health through a comprehensive program of basic and clinical investigations, population-based studies, and demonstration and education research. Fulfillment of this goal depends on continuous development of highly trained individuals from a wide variety of disciplines and specialities. To this end, we must encourage and support young scientists in the earliest phases of their careers to ensure that they develop the competencies and breadth of expertise needed to address the complex, multifaceted research challenges that they will face as they become independent researchers.

Training grants provide a fine mechanism for developing many investigators, but the need for well-trained clinical researchers, in particular, is so pressing that we must seek out and capitalize upon other opportunities. The newly developed Specialized Centers of Clinically Oriented Research (SCCORs; see January 29, 2002 issue of Circulation), which require clinical and basic scientists to work together on a unified theme, offer one such opportunity. NHLBI-supported clinical research networks and multicenter clinical studies present others. All three types of programs often include among their research staffs new and relatively inexperienced clinical investigators who could grow tremendously in such environments if properly nurtured.

This will not happen, however, if these junior staff function solely as "employees." We must extend their horizons beyond the confines of their job-related tasks, and expose them to a panoramic view of clinical research. To facilitate this essential step, the NHLBI is inviting applicants for SCCORs or for new or competing renewal clinical research networks and multicenter clinical studies (whether Institute- or investigator-initiated) to request up to $100,000 in direct costs per year for a Clinical Research Skills-Development Core. The Core's objective is to support activities to assist new clinical investigators in progressing to more senior status by enhancing their research skills. The amount is in addition to the usual budget cap on SCCORs; for competing renewal applications for networks or multicenter studies, it is in addition to the increase ordinarily allowed by the NHLBI (i.e., 10 percent above the recommended amount for the last noncompeting project period). A Clinical Research Skills-Development Core is not required, however, and its absence will not disadvantage an applicant. The quality of the Core will be evaluated as a separate part of the initial peer review process, and its priority score will have no effect on the overall score of an application.

As an optional part of the new SCCORs, we envision that the Cores will emphasize developmental opportunities that provide experience with new technologies and skills. Applicants are encouraged to propose innovative strategies for cross-disciplinary career development to achieve the goal of exposing new clinical investigators to additional research approaches. Examples are a program of seminars focusing on scientific topics that include an integration of basis and clinical studies, or an "exchange" program wherein clinical investigators spend time in basic science laboratories. Applicants involved in clinical research networks and multicenter studies are encouraged to develop Cores that will enable junior staff to gain experience in important aspects of human subjects research, including clinical trial design, protocol development and management, design and conduct of ancillary studies, biostatistics, and epidemiology. In addition to developing the research skills of new clinical investigators, all Cores should address other skills necessary for a successful research career, such as grant writing, ethical conduct of research, and manuscript preparation. Moreover—and most important—Cores must ensure that the investigators receive the mentoring they need to foster their research careers.

The Clinical Research Skills-Development Core is intended for staff investigators with limited clinical research experience, including fellows and junior faculty members. Investigators who have completed NIH career (K-series) awards or who have received independent research grant support are not eligible to participate as new investigators under this program.

If a Core is proposed, it must be directed by an investigator with strong educational and mentoring credentials who will devote a minimum of 5 percent effort as its leader. To facilitate multidisciplinary developmental activities and appropriate mentoring, active involvement by the principal investigator and other senior investigators is strongly encouraged.

Applications for Clinical Research Skills-Development Cores will be evaluated in terms of their potential effectiveness in developing the skills and research capabilities of new clinical investigators as reflected in the following required elements of the application:

• A summary of the types of skills that would be developed and the specific developmental activities proposed;
• A detailed discussion of how the mentoring and professional development of each selected new investigator are to be achieved, including progression to more independent status;
• The credentials and track record of the Clinical Research Skill-Developmental Core Leader, the Principal Investigator, and other senior staff;
• [for SCCORs] A plan for coordinating the activities of participating senior investigators;
• [for clinical research networks and multicenter clinical studies] A plan for coordinating activities of new investigators with the network or multicenter study protocols and committee functions;
• A plan for monitoring the progress of new investigators;
• A description of existing opportunities within the applicant's institution for supporting investigator development and steps taken to avoid overlap with or duplication of these efforts; and
• A detailed development plan for each proposed new investigator (or a representative plan and proposals for tailoring it to needs of multiple new investigators) including required course work, clinical enrichment activities such as special lectures, visiting-scientist symposia, seminars, and workshops.

Costs allowable for inclusion within the $100,000 direct costs per year limit include salary support for the Core Leader and other participating senior investigators and staff, travel costs for new investigators, supplies and equipment to be used in support of developmental activities, and costs for courses, seminars, workshops, and other activities directly related to the development plan. All costs requested in this Core must be justified with respect to developmental activities and may not be used to supplement the costs of research proposed in the clinical research network or multicenter study.

Since the Core is intended to serve new clinical investigators who occupy positions and receive salary support from the grant-supported program, salary support for the new investigators is neither needed nor allowable as a Core cost. All new clinical investigators supported by the research project should be eligible to participate in Core-sponsored activities so long as they have not attained independent status. However, attaining independent status should be an objective of the Core activities, so participating new investigators should be encouraged to apply for either a career development award, a patient-oriented regular research grant, or any other source of independent research or career development support. Although the participating new investigators will be expected to devote essentially full-time effort to research during this period, they may devote an appropriate percentage of their time to maintaining clinical skills.

We anticipate that the applications we receive for Cores will be as diverse as their parent programs. Applicants should consider carefully how they plan to capitalize on their unique, multidisciplinary environments to develop the new cadre of investigators in science and medicine.

Our concept of the Clinical Research Skills-Development Cores may, at first glance, appear to be overly ambitious. Let me assure you that we are well aware that it will not be appropriate for every recipient of applicable grants. For example, some of the institutions that we invest considerable resources in may conduct top-quality, cutting-edge research but do not make the intellectual welfare of trainees a priority; the new Core is not intended for those programs. Instead, the money will be used to develop additional resources in multidisciplinary research programs staffed by outstanding senior researchers who have consistently demonstrated their dedication to preparing the next generation of investigators.