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

ices for each stakeholder group. It also summarizes the findings into recommendations to be implemented by various organizations and agencies. Specific recommendations include:

For all 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.

-- 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 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 similar 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 Researc
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SOURCE The Endocrine Society
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