Successful Strategies for Engaging Women and Minorities in Clinical Trials

OVERVIEW Since the early 1990s, the FDA Office of Women's Health and the Society for Women's Health Research (SWHR) have worked toward the common goals of advancing women's health research through education, policy, and science. Together these groups, with the support of the FDA Office of Minority Health, convened the meeting " Dialogues on Diversifying Clinical Trials, " to address the need for greater representation of women and minority groups in the development of medical products. Invited speakers included representatives from the pharmaceutical and biotechnology industry, academic institutions, advocacy groups, government agencies, clinicians, and patients. Special interest brainstorming groups and a stakeholder roundtable session provided participants with an opportunity to provide reflections and new ideas. The major themes surrounded new and novel methods for improving recruitment and retention of women and minorities, community‐based approaches to clinical trial design, and federal perspectives on guidelines and regulations to improve diversity in government‐ and industry‐funded research. The presentations stressed the disparate nature of clinical trial representation past and present, but also highlighted successful means and methods for increasing women and minority enrollment. There are well‐established dif ferences in incidenc e of disease between the sexes and among racial or ethnic groups. This meeting high lighted some of the more striking sex‐ and race‐based disparities in disease prevalence. The most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, lung). Some of these variations result from genetic variants that are more common in certain subpopulations than others are, however lifestyle and socioeconomic factors influence risk bias based on sex or race/ethnicity. For instance, women live longer and bear greater disease burden than men, and require extra care for reproductive health and childbearing needs. Ethnic minority groups are disproportionately affected by poverty and low socioeconomic status, which are linked to poorer health outcomes.