Journal of Clinical Endocrinology & Metabolism
, doi:10.1210/jc.2007-2172
The Journal of Clinical Endocrinology & Metabolism Vol. 92, No. 12 4557-4559
Copyright © 2007 by The Endocrine Society
Commentary on "Increasing Minority Participation in Clinical Research": A White Paper from The Endocrine Society
Maria Alexander-Bridges,
Loretta L. Doan on behalf of the writing group of The Endocrine Society’s Task Force on Increasing Minority Participation in Clinical Research1
Amgen Inc. (M.A.-B.), Thousand Oaks, California 91320-1799; and The Endocrine Society (L.L.D.), Chevy Chase, Maryland 20814
Address all correspondence and requests for reprints to: Maria Alexander-Bridges, Amgen Inc., One Amgen Center Drive, MS 38-3-C, Thousand Oaks, California 91320-1799. E-mail: maalexan{at}amgen.com.
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Introduction
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Underrepresentation of racial and ethnic minorities in clinical research limits the applicability of trial results to diverse subpopulations. Recognizing an ongoing need to increase participation by minorities, The Endocrine Society established a task force of thought leaders from all stakeholder groups—the pharmaceutical industry, federal agencies, academia, and community groups—to develop a white paper outlining recommendations for meeting this need. The primary goal is to ensure that clinical research supporting the safety and efficacy of pharmaceutical products and the validity of biomarkers used to design therapeutic strategies is based on statistically powered data derived from minority subpopulations. To realize this goal, all stakeholder groups must collaborate to ensure that diverse subpopulations are included in clinical trials.
Efforts to improve minority representation should mirror and expand on the successful measures undertaken by the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) to ensure representation of women in clinical trials at academic institutions. Although NIH has been quite successful in requiring inclusion of minorities in the clinical trials it sponsors, pharmaceutical companies fund their own new drug investigations and do not face analogous requirements. Although the FDA has posted a guidance advising inclusion on its website (1), each company is left to decide whether and at what stage of drug development it is necessary and financially feasible to undertake this effort.
We have identified three issues that must be addressed for minority inclusion to be required by the FDA and realized by pharmaceutical companies. First, it would be important to agree upon meaningful, science-based characterizations of minority subpopulations. Second, an algorithm for determining what constitutes an adequate number of diverse patients in any given trial should be developed. Third, the infrastructure to support routine identification of a broad spectrum of potential study participants would have to exist.
The Endocrine Society’s white paper (2) presents both barriers and best practices from the perspective of each of four stakeholder groups. It also summarizes the findings in global recommendations to be implemented by discrete organizations or agencies. This Commentary is a brief overview of the issues and recommendations presented in the white paper.
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Role of Pharmaceutical Companies and Contract Research Organizations (CROs)
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Pharmaceutical companies and CROs must remain economically viable while functioning within a regulatory framework. As such, they have developed an efficient system of recruiting clinical trial sites (physicians and their patients), rather than individual study volunteers. Including ethnic minorities as trial participants is perceived to add to the complexity and cost of trials. With no current mandate to include minorities in industry-sponsored trials, most pharmaceutical companies and CROs do not require inclusion and have not actively recruited minority physicians with the needed patient populations. Requirements for inclusion will change the actions of industry by stimulating recruitment of minority sites with monies routinely budgeted for new site selection.
Despite the widespread belief that the 40-yr U.S. Public Health Service study of the effect of untreated syphilis in Afro-American males is an impediment to recruitment (3), Wendler et al. (4) and Katz et al. (3) have shown that members of minority populations, although understandably cautious, will participate in clinical trials when invited to do so, particularly when approached by their own physicians. Because minority patients often choose physicians of their own ethnicity, recruiting minority physicians and physicians who have access to minority patients and have been properly trained in cultural competencies would be an important source of ethnic minority trial volunteers. Thus, pharmaceutical companies and CROs that want to increase participation by minority patients will need to diversify the clinical practices they engage to perform clinical trials. Once identified, these clinical sites can provide educational opportunities to their patients and address barriers to their participation in an effective way.
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Role of the NIH and Academic Institutions
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The NIH Strategic Plan to Eliminate Health Disparities (5) outlines approaches to reduce and eventually eliminate disparities in health and the care received by minority patients. The strategic plan for implementing change focuses on three major areas: 1) research; 2) building research capacity; and 3) outreach. The NIH is currently addressing many factors that contribute to health disparities, including differences in biology, access and quality of health care, socioeconomic status and education level, and cultural attitudes that impede equality in care.
The NIH has an established policy and guidelines (6) for the inclusion of women and minorities as clinical research subjects and has posted guidelines related to both categorization of racial and ethnic minorities and the responsibilities of regulators and researchers. The policy clearly describes a tiered approach to research that ensures adequate inclusion of women and minorities at each step and under defined circumstances. Investigators applying for federal funding must meet the established policy during peer review or funding is withheld.
We applaud NIH’s attention to minority recruitment. However, individual investigators with limited budgets often find it difficult to undertake the public relations activities that are required to recruit individual minority subjects. We suggest that the NIH and investigators at academic institutions may benefit from studying and possibly adopting the recruitment mechanisms used by industry. Specifically, by supporting the growth of organizations (similar to CROs) that specialize in providing ready access to diverse clinical sites, NIH would reduce the need for individual investigators to undertake expensive and time-consuming efforts to diversify each new NIH trial. We suggest that all institutions interested in clinical research—NIH, foundations, pharmaceutical companies, and medical centers—would benefit from working together to build networks of diverse, community-based practitioners who can participate in clinical trials.
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Role of the FDA
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The FDA has given considerable attention to the influence of gender on response to drugs and has undertaken multiple actions to address the issue. However, the agency has failed to pursue adequately efforts to ensure the inclusion of racial and ethnic minorities in clinical trials. The FDA’s 2005 guidance (1) on the collection of race and ethnicity data merely suggests how racial and ethnic data should be categorized, but it does not define principles or establish criteria for adequately diverse trials. Nevertheless, a guidance can be an intermediate step to developing regulations. The FDA should lead efforts to improve its guidance to industry and investigators, facilitating acquisition and analysis of racial and ethnic data and advancing the value of doing so.
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Role of the Community and Community Leaders
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Public health endeavors that involve minority populations must be approached with the input and support of those who will be affected as part of a broad strategic effort. Minority participation as clinical trial volunteers requires that minority communities be 1) informed of clinical trials, 2) invited to volunteer, and 3) able to participate. Barriers exist in both the communication of opportunities to minority communities and the ability of minority individuals to participate. Overcoming these barriers requires community outreach and cultural activism on a regular and persistent basis. Community-based coalitions and advisory boards provide ideal opportunities to combine outreach and activism. In addition to serving as a conduit of information about ongoing clinical trials to the community, such coalitions could advocate for recruitment and retention of minority healthcare professionals and patients, responsive collection and dissemination of clinical trial results, reporting on race and ethnicity in trials, and establishment of community-wide disparities work groups.
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Examples of The Endocrine Society’s Specific Recommendations
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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.
By encouraging those who conduct clinical research to engage minority communities through community-based physicians, we are encouraging lasting ties and persistent interaction among the stakeholder groups that must work together to solve the problem of inadequate representation of minorities in clinical trials. Investigators and physicians who treat minority patients must remain diligent in their ongoing efforts to diversify trials even as we all work toward a permanent solution.
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Acknowledgments
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We acknowledge Judith A. Johnson, M.D.; Fran E. Kaiser, M.D.; and Rachel B. Wagman, M.D., for critical reading and many insightful suggestions.
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Footnotes
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This work was supported by a grant from the Robert Wood Johnson Foundation.
The writing group comprises the authors of the original white paper (in alphabetical order): Lawrence Agodoa, M.D.; Alfonso J. Alanis, M.D.; Maria Alexander-Bridges, M.D., Ph.D.; Naomi Bitow, M.P.H.; Loretta L. Doan, Ph.D.; G. Alexander Fleming, M.D.; Ken Getz, M.S., M.B.A.; Brian K. Gibbs, Ph.D., M.P.A., OTR/L; and Deborah Prothrow-Stith, M.D. Alfonso Alanis briefly described some of his work as part of an article in the December 2006 issue of The CenterWatch Monthly Newsletter. Rhonda Bentley-Lewis provided a written summary of her personal experience, which is included as Appendix I of the white paper.
The National Medical Association (http://www.nmanet.org/) is engaged in ongoing efforts to increase the pipeline of minority researchers through initiatives such as Project IMPACT.
The Hormone Foundation, The Endocrine Society’s public education affiliate, has created a patient fact sheet with information for individuals who are interested in participating in clinical trials. The fact sheet may be accessed either by going to the web address provided in reference 2 or by visiting www.Hormone.org.
1 Members of the writing group are listed in Acknowledgments. 
Abbreviation: CRO, Contract research organization.
Received September 26, 2007.
Accepted October 18, 2007.
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References
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- 2005 Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. http://www.fda.gov/cber/gdlns/racethclin.htm
- Agodoa LY, Alanis AJ, Alexander-Bridges M, Bitow N, Doan LL, Fleming GA, Getz KA, Gibbs BK, Prothrow-Stith D 2007 Increasing minority participation in clinical research. http://www.endo-society.org/publicpolicy/health_disparities/
- Katz RV, Green BL, Kressin NR, Claudio C, Wang MQ, Russell SL 2007 Willingness of minorities to participate in biomedical studies: confirmatory findings from a follow-up study using the Tuskegee Legacy Project Questionnaire. J Natl Med Assoc 99:1052–1060[Medline]
- Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA, Brawley OW, Gross CP, Emanuel E 2006 Are racial and ethnic minorities less willing to participate in health research? PLoS Med 3:e19
- Strategic Research Plan and Budget to Reduce and Ultimately Eliminate Health Disparities, Fiscal Years 2002–2006. Bethesda, MD: National Institutes of Health. http://ncmhd.nih.gov/our_programs/strategic/volumes.asp
- NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research—amended. Bethesda, MD: National Institutes of Health. http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm
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Introduction
Role of Pharmaceutical Companies...
