The committee concluded that new opportunities for clinical research are growing at a rapid pace. In addition, the committee believes that the present cohort of clinical investigators is not adequate and many are not suitably prepared to address many of the important questions that are arising, particularly in areas like gene therapy and outcomes research. Furthermore, numerous obstacles confront clinical researchers and clinical research trainees at various points in their career pathways, and these obstacles may dissuade them from pursuing clinical research careers. The committee is concerned that the health research community may be unable to address even a fraction of these opportunities, and this may delay substantially the development of new advances in medicine.

To foster improved clinical investigation, to facilitate and stimulate high-quality training for clinical investigators, and to ensure a supply of highly skilled clinical investigators, the committee calls for a multifaceted and concerted effort. The U.S. congress, industry, professional organizations, organized medicine, NIH and other federal agencies, as well as the nation's universities and academic health centers will need to work in partnership to meet these research and training needs. Voluntary health organizations, accrediting and certifying agencies, and medical professional societies all have a role to play in the careers of clinical investigators. Most of the committee's recommendations do not necessarily require increased funding to effect change. The committee emphasizes that effective and strong leadership in academic health centers, in government, and in industry is a critical ingredient in the process for improving clinical research and developing rewarding clinical research career pathways. Whereas each individual recommendation is directed to a specific group or organization, collectively the recommendations represent a package of reforms needed for redefining careers in clinical investigation.

RECOMMENDATIONS

NIH and Other Federal Agencies Supporting Research

Among the federal agencies, NIH continues to be the trendsetter in the support of biomedical research, both basic and clinical, and in the training of clinical investigators. Accordingly, efforts carried out by NIH will have a major impact on progress in the development of the clinical investigator. A number of approaches are recommended to enhance the effectiveness of NIH as a leader in patient-oriented clinical research.



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