Central challenges facing the national clinical research enterprise

JAMA. 2003 Mar 12;289(10):1278-87. doi: 10.1001/jama.289.10.1278.


Medical scientists and public health policy makers are increasingly concerned that the scientific discoveries of the past generation are failing to be translated efficiently into tangible human benefit. This concern has generated several initiatives, including the Clinical Research Roundtable at the Institute of Medicine, which first convened in June 2000. Representatives from a diverse group of stakeholders in the nation's clinical research enterprise have collaborated to address the issues it faces. The context of clinical research is increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants. These factors have contributed to 2 major obstacles, or translational blocks: impeding the translation of basic science discoveries into clinical studies and of clinical studies into medical practice and health decision making in systems of care. Considering data from across the entire health care system, it has become clear that these 2 translational blocks can be removed only by the collaborative efforts of multiple system stakeholders. The goal of this article is to articulate the 4 central challenges facing clinical research at present--public participation, information systems, workforce training, and funding; to make recommendations about how they might be addressed by particular stakeholders; and to invite a broader, participatory dialogue with a view to improving the overall performance of the US clinical research enterprise.

MeSH terms

  • Biomedical Research* / economics
  • Biomedical Research* / legislation & jurisprudence
  • Clinical Trials as Topic* / economics
  • Clinical Trials as Topic* / ethics
  • Clinical Trials as Topic* / legislation & jurisprudence
  • Clinical Trials as Topic* / standards
  • Confidentiality
  • Conflict of Interest
  • Consensus
  • Cooperative Behavior
  • Evidence-Based Medicine / organization & administration*
  • Health Occupations / education
  • Health Policy*
  • Health Priorities
  • Humans
  • Information Systems
  • Informed Consent
  • Investments
  • National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division
  • Patient Selection
  • Policy Making
  • Private Sector
  • Research Personnel / education
  • Research Personnel / supply & distribution
  • Research Support as Topic / organization & administration*
  • United States
  • United States Government Agencies