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The Endocrine Society Publishes White Paper Calling for Greater Minority Participation in Clinical Research
Date:12/5/2007

de toward including minorities in clinical research, and the key parties involved in planning and conducting clinical trials (investigators, sponsors, and regulators) have not yet made this a priority.

Contributing to this problem is the prevailing preconception that minority volunteers fail to participate in trials because they harbor distrust of research and researchers. "Many studies have tried to determine the reasons that minorities are underrepresented in clinical studies," said Dr. Alexander-Bridges. "Lack of access and whether minority patients are asked to participate by their personal physician appear to be the predominant barriers. This is why we also recommend that all physicians serving minority patients be involved in this process."

To address the problem, The Endocrine Society's white paper calls on all stakeholder groups--the pharmaceutical industry, contract research organizations, the U.S. Food and Drug Administration (FDA) and other federal agencies, and community groups--to engage in efforts to expand participation of minority physicians as well as minority patients in clinical research.

The primary goal is to ensure that clinical research supporting the safety and efficacy of new drug products and the validity of laboratory tests used to design treatments are based on accurate data derived from diverse populations.

In the JCEM commentary, Dr. Alexander-Bridges clarifies three issues that the various stakeholder groups must address. First, all groups should agree on meaningful, science-based characterizations of minority subpopulations. Second, researchers should develop a system to determine what constitutes an adequate number of diverse patients in any given trial. Third, the medical community needs an infrastructure to support routine identification of a broad spectrum of diverse study participants, both physicians and patient volunteers.

The Society white paper presents both barriers and best pract
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SOURCE The Endocrine Society
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