the number of randomized trials increasing 35 percent between 2005 and 2010.

The design, conduct, and analysis of clinical trials involves a broad range of public and private institutions, including academic medical centers, hospitals, community practices, pharmaceutical and medical device industries, voluntary health organizations, and contract research organizations (CROs). The NIH Clinical Center in Bethesda, Maryland, is a unique example of an organization wholly devoted to clinical trials. The Center conducts a robust program of intramural clinical trials, with more than 1,250 physicians and the bed capacity for 240 inpatients, all of whom are participants in one of the Center’s more than 1,400 active research protocols. Most of the Center’s intramural clinical trials are phase I or phase II research—that is, early, proof-of-concept studies, rather than later, confirmatory research, which is generally phases III and IV (see Appendix B: The Clinical Trials Process for definitions of phases 0 through IV).

Multiple Challenges to the Clinical Trials Enterprise

Despite increases in both funding and effort and an understanding of the requirements for successful clinical trials (see Box 2-1), the enterprise continues to falter, said Annetine Gelijns, Co-Chair, Department of Health Evidence and Policy, Mount Sinai School of Medicine. Some of the barriers to participation in clinical trials by key groups—patients, academic institutions, community physicians, and researchers themselves—and potential ways to overcome them are described in the succeeding paragraphs.

Barriers to Patient Recruitment

Clinical trials experience significant obstacles in patient recruitment.

BOX 2-1a
Elements for Successful Clinical Trials

•   Well-defined clinical trial goals and target patient population

•   Realistic patient accrual strategy

•   Community outreach and education, building trust

•   Community/patients advisory boards

•   Well-informed community physicians and other health care professionals

•   Effective patient retention strategy

•   Protocol implementation support team


a Material presented by Juan Lertora, Director, Clinical Pharmacology, NIH Clinical Center.

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