June 2, 2007

Toronto, Canada—The Endocrine Society recommends that Congress, federal agencies, and academia undertake major new initiatives to ensure effective, broad-based minority participation in clinical research. These efforts are essential to ensure that data from clinical trials represents and serves the broadest possible patient base.

The recommendations, part of a White Paper developed by a special Society task force, were unveiled on June 2, 6:30 p.m., as part of The Endocrine Society’s 89th Annual Meeting in Toronto.

“Recruiting minority and economically disadvantaged research volunteers is a perennial challenge,” said Dr. Maria Alexander-Bridges, Associate Professor of Medicine at Harvard Medical School, Diabetes Unit, Massachusetts General Hospital, and head of the Society’s task force on increasing minority participation in clinical research.

“Nevertheless, as we find more examples of racial groups responding differently to medications, the importance of including enough minority research volunteers becomes clear. If we want to ensure that all our citizens can take advantage of new therapies and the promise of personalized medicine, then we need mechanisms in place to ensure sufficient representation of diverse ethnic and socioeconomic groups in our clinical studies.”

“To achieve this goal on a consistent basis, we will have to make significant changes in the way we go about recruiting diverse patients to clinical trials,” she said.

Recommendations from the Society include:

For stakeholders:

• Establish a collaborative effort among the National Institutes of Health (NIH), the pharmaceutical industry, and academic institutions to expand the mandate of current programs to include resources for the development of a nationwide network of minority physician researchers and patient volunteers.
• Revision of the Office of Management and Budget Directive No. 15 definitions to reflect more relevant anthropologic categories so that information gathered will be scientifically sound in addition to being easily compared across federal agencies.
• Agree on satisfactory parameters for recruitment of representative subpopulations.
• Consider funding grants to support meta-analysis of existing safety and efficacy data with respect to race/gender.

For Congress:

• Pass legislation requiring clinical trials for Food and Drug Administration (FDA) approval of drugs to include women and minorities.
• Establish and/or empower an Office of Minority Health within the Office of the FDA Commissioner with the same monitoring authority as the Office of Women’s Health.
• Provide incentives such as tax incentives or patent extensions for companies that adhere to FDA guidance on inclusion of minorities in clinical trials and/or undertake additional trials.

For FDA:

• Require that safety and efficacy data be established as valid for women and minorities (as appropriate) for the approval of new drug applications and investigative new drug applications.

For NIH (as funding agency) and academic institutions (as implementer):

• Adopt mechanisms such as the Department of Defense Small Business Innovation Research program that would encourage entrepreneurs to establish contract research organizations and/or limited liability corporations dedicated to recruiting diverse physicians and study populations.
• Establish and maintain an infrastructure of minority patient populations from which individual investigators and researchers at academic institutions can easily and efficiently recruit volunteers.
• Fund and create Community Research Advisory Boards at appropriate sites.
• Establish training programs for community-based physicians who are interested and willing to perform clinical research.
• With respect to increasing the pipeline, medical schools should increase enrollment of medical students based on projected population changes over the next 30 years.
• Medical schools should offer training in Good Clinical Research Practice and Cultural Competencies to all trainees and staff members who may directly or peripherally engage in clinical research.

There has been a prevailing preconception that minority volunteers failed to participate in trials because they harbored distrust of research and researchers. A recent study of nearly 70,000 volunteers concluded, however, that minority volunteers are just as likely to participate in clinical trials when approached by their own physician as their Caucasian counterparts. “The limiting factor appears to be whether minority patients are asked to participate,” said Alexander-Bridges.

This effort was funded by a grant from the Robert Wood Johnson Foundation.

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Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org.