A new study assessed the effects of FDA regulations and guidance in clinical drug trials that want to encourage greater involvement of women and minorities, it has found appropriate levels of female participation based on the estimated sex ratio of people overwhelmed by a particular disease. According to the study published in the Journal of Women’s Health, some racial minorities, especially African-Americans, remain underrepresented in most drug development programs.
Emmanuel Fadiran, Ph.D., and his 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 has examined the demographic make-up of clinical trial participants and whether the safety and efficacy data were obtained for both men and women for new drugs approved in between 2013 and 2015 by CDER. To assess the sex-based representation in the drug safety and efficacy drug testing, in clinical trials the researchers determined the ratio of the proportion of women for a particular disease population relatively it is estimated to the proportion of women in the disease population (PPR) for a new drug indication.
During the study period, the authors reported that sex-based analyses for both safety and efficacy were conducted for the majority of new drug applications. Moreover, representation of women in the clinical trials was appropriate for more new drugs when the PPR was considered.
“Fadiran et al researched the results which help to assure us that in all clinical phases of drug studies women are being included at an appropriate level,” said Susan G. Kornstein, MD, President of the Academy of Women’s Health and 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. “Furthermore, it will be more important to going forward in the new drug development to remain vigilant to the potential for sex-based disparities, and to address the ongoing underrepresentation of some racial minorities, especially for a particular drug indication when they may have a relatively high prevalence.”
In all clinical phases of drug studies, the importance of considering the differences between the male and female sex in clinical decision-making is crucial. Nonetheless, in the recent decade, it has been acknowledged that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have interfered the progress of understanding women’s response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This reviewed in the clinical trials that the outlines of the history and progress of the women’s inclusion of prescription drugs and present considerations for researchers, clinicians, and academicians on this issue.