Clinical Research Networks and Multicenter Clinical Studies Clinical Research Skills Development Core

National Heart, Lung, and Blood Institute
National Institutes of Health

July 2010

Clinical research networks and multicenter clinical studies typically include among their research staffs new and relatively inexperienced clinical investigators. The NHLBI recognizes that their progression to established investigators can be enabled by opportunities to be exposed to and develop additional research skills. Because they complete several different protocols in a relatively short period of time, clinical research networks can provide experiences in many phases of clinical trials and aspects of patient-oriented research. Large multicenter clinical studies can enable skills development in such areas as epidemiology, database development, and clinical trial design. In addition, both clinical research networks and multicenter clinical studies allow new investigators to interact with leading clinical investigators, receive mentoring in clinical investigation, and participate in multi-institutional research experiences.

The NHLBI is interested in ensuring that the full potential of clinical research networks and multicenter clinical studies to foster the clinical research careers of new investigators is realized. Therefore, some institute-initiated new or competing renewal clinical research networks and multicenter clinical studies include the option of submitting such a core. However, it must be stated in the RFA or RFP that the NHLBI is willing to accept the core. The objective of the Core is to support activities to assist new clinical investigators in progressing to more senior status by enhancing their research skills. Such a Clinical Research Skills Development Core is not required, and its absence will not disadvantage an applicant. If proposed, the quality of the Core will be evaluated as a separate part of the initial peer review process, the evaluation being based on the specific components outlined below. The priority score on the Core will have no effect on the overall score of an application.

The Clinical Research Skills Development Core will enable newly trained clinical personnel to be exposed to and gain experience in important aspects of human subjects research, including clinical trial design, protocol development and management, bioethics, design and conduct of ancillary research projects, biostatistics, epidemiology, and manuscript preparation. In addition to developing the research skills of new clinical investigators, the 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 had a previous K series award are not eligible to participate as new investigators under this program.

If a Clinical Research Skill Development 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 within the applicant center is strongly encouraged.

An application for a Clinical Research Skills Development Core will be evaluated in terms of its potential effectiveness in developing the skills and research capabilities of new clinical investigators as reflected in the following required elements of the application:

1. A summary of the types of skills that would be developed and the specific developmental activities proposed;
2. 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;
3. The credentials and track record of the Clinical Research Skills Developmental Core Leader, the Principal Investigator, and other senior staff;
4. A plan for coordinating activities of new investigators with the network or multicenter study protocols and committee functions;
5. A plan for monitoring the progress of new investigators;
6. 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
7. 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 investigators, and workshops.

Costs allowable for inclusion within the $100,000 direct costs per year limit for the Clinical Research Skills Development Core 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 clinical network or multicenter study, salary support for the new investigators is neither needed nor allowable as a Core cost. All new clinical investigators supported by the clinical network or multicenter study 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.