CHEVY CHASE, Md., Dec. 5 /PRNewswire-USNewswire/ -- A new white paper published by The Endocrine Society recommends that Congress, federal agencies, and academia undertake major new initiatives to ensure effective, broad-based minority participation in clinical research. The white paper outlines a series of recommendations to ensure that data from clinical trials represent and serve the broadest possible patient base.
The white paper, developed by a special Society task force, is published on the Society's Web site at http://www.endo-society.org/publicpolicy/health_disparities/, and a commentary on the paper is published in the December 2007 issue of the Journal of Clinical Endocrinology & Metabolism (JCEM), a publication of The Endocrine Society.
"Recruiting of minority and economically disadvantaged research volunteers has been a perennial challenge," said Dr. Maria Alexander-Bridges, head of the Society's task force on increasing minority participation in clinical research. "Addressing this problem will require significant changes in the way clinical trials are organized, and interventions at multiple levels that no agency or institution could undertake alone." Dr. Alexander-Bridges, currently clinical research director at Amgen Inc., secured a grant for The Endocrine Society from the Robert Wood Johnson Foundation in 2006--while an associate professor of medicine at Massachusetts General Hospital and member of the Society's Government Relations Committee--to develop the white paper and to communicate this issue to the public.
The under-representation of minorities continues to be a problem in all types of clinical and medical research, and it limits the applicability of trial results to diverse subpopulations. This is even true for those diseases that predominantly affect ethnic and racial minorities. Regrettably, little progress has been made 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 practices 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.
-- 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.
-- 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.
-- Participate in an NIH-sponsored summit to plan a nationwide consortium to provide training, mentoring, startup funds, and ongoing opportunities for participation of diverse community physicians in clinical trials.
-- 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.
This activity, including development of the white paper, was funded by a grant from the Robert Wood Johnson Foundation.
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, Maryland. To learn more about
the Society, and the field of endocrinology, visit our web site at
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|SOURCE The Endocrine Society|
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