Endocrine Insider
December 13, 2007

The Endocrine Society has launched a new Web page dedicated to health disparities initiatives. The site features the Society’s recently released white paper “Increasing Minority Involvement in Clinical Research,” a commentary on the paper published in the December 4 issue of the Journal of Clinical Endocrinology and Metabolism (JCEM), a news release about the paper, and an accompanying patient guide from the Hormone Foundation. Additionally, the site offers links to related activities by outside organizations and to clinical trials resources.

All this may be accessed at the following URL: http://www.endo-society.org/publicpolicy/health_disparities/

The release of the white paper reinforces the Society’s advocacy priority of eliminating health disparities, which are prevalent in those suffering from many endocrine diseases, including obesity and diabetes. The paper and supporting materials and activities were made possible by a grant from the Robert Wood Johnson Foundation, awarded to the Society with Dr. Maria Alexander-Bridges, a former member of the Society’s Advocacy and Public Outreach Core Committee, as project leader. The paper and its recommendations were developed by a task force of Society members and non-member experts assembled by Dr. Alexander-Bridges. The recommendations are intended to support efforts already in place and to engage the broader stakeholder community in meaningful and effective change.

The primary goal described in the white paper 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, an algorithm to determine what constitutes an adequate number of diverse patients in any given trial should be developed. Third, the clinical research community needs an infrastructure to support routine identification of a broad spectrum of diverse study participants, both physicians and patient volunteers.

Some specific examples of the Society’s recommendations are:

All stakeholder groups should:

• Participate in an NIH-sponsored summit to plan a nationwide consortium to provide training, mentoring, start-up funds, and ongoing opportunities for clinical trial participation to minority physicians in the community and in academia, at historically black academic centers, at ethnic health institutes, and at professional organizations such as the National Medical Association.
• Develop appropriate and relevant categorizations of ethnicity.
• Develop parameters to define appropriate minority representation in a given study, considering disproportionate representation of disease in particular subpopulations.

Congress and/or FDA should:

• Establish an Office of Minority Health within the FDA to implement the suggested changes and evaluate current and ongoing studies.
• Adopt NIH guidelines on the inclusion of women and minority populations such that data collected would support detection of racial and ethnic differences in pharmacokinetics and biomarker expression.
• Require, rather than recommend, adherence to the guidelines.

NIH and academic institutions should:

• Use mechanisms such as the Small Business Innovation Research program to encourage entrepreneurs to establish CROs dedicated to recruiting diverse physicians.
• Establish training and/or mentorship programs to forge connections between academic researchers and minority community-based physicians.
• Provide Good Clinical Research Practices and Cultural Competence instruction to health-care professionals who may directly or peripherally engage in clinical research.

As described in the November 21 issue of Endocrine Insider, this topic was brought before the American Medical Association’s (AMA) House of Delegates (HOD) at its Interim meeting in November. The Society’s delegation to the HOD, Drs. Robert Vigersky, Susan Sherman, and Vineeth Mohan, introduced the resolution, which was referred to the AMA Board of Trustees for further consideration. The Board will make its recommendations regarding AMA support of the resolution prior to the next HOD meeting to take place in June 2008. The Society will continue to develop its advocacy strategy to logically implement the recommendations outlined in the paper and will pursue community and public outreach activities to further broadcast the message.