A new study to assess the effects of FDA regulations and guidance that sought to encourage greater inclusion of women and minorities in clinical drug trials found appropriate levels of female participation based on the estimated sex ratio of people affected by a particular disease. In contrast, some racial minorities, especially African-Americans, remain underrepresented in most drug development programs, according to the study published in the Journal of Women’s Health.
Emmanuel Fadiran, PhD, and colleagues from the Center for Drug Evaluation and Research (CDER) and the Office of Women’s Health in the Office of the Commissioner of the FDA examined the demographic make-up of clinical trial participants and whether efficacy and safety data were obtained for both men and women for new drugs approved between 2013 and 2015 by CDER. To assess sex-based representation in drug efficacy and safety testing, the researchers determined the ratio of the proportion of women in clinical trials for a particular disease population relative to the estimated proportion of women in the disease population (PPR) for a new drug indication.
The authors reported that sex-based analyses for both efficacy and safety were conducted for the majority of new drug applications during the study period. Furthermore, representation of women in clinical trials was appropriate for more new drugs when the PPR was considered.
“The results presented by Fadiran et al. help to reassure us that women are being included at an appropriate level in all phases of clinical drug studies,” said Susan G. Kornstein, MD, Editor-in-Chief of the Journal of Women’s Health, Executive Director of the Virginia Commonwealth University Institute for Women’s Health in Richmond, Virginia, and President of the Academy of Women’s Health. “However, it will be important going forward to remain vigilant to the potential for sex-based disparities in new drug development, and to address the ongoing underrepresentation of some racial minorities, especially when they may have a relatively high prevalence for a particular drug indication.”
Source: Mary Ann Liebert, Inc.; November 7, 2017.