New Rochelle, NY, November 7, 2017--A new study to assess the effects of U.S. Food and Drug Administration (FDA) regulations and guidance, intended to encourage greater inclusion of women and minorities in clinical drug trials, has shown appropriate levels of female participation based on the estimated sex ratio of people affected by a particular disease. In contrast, some racial minorities, and especially African Americans, remain under-represented in most drug development programs, according to the study published in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Women's Health website.
Emmanuel Fadiran, PhD and colleagues from the Center for Drug Evaluation and Research (CDER), and the Office of Women's Health, 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 2013-2015 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 estimated disease prevalence by sex (PPR) was considered. These findings are presented in the article entitled "Representation of Women and Minorities in Clinical Trials for New Molecular Entities and Original Therapeutic Biologics Approved by FDA CDER from 2013 to 2015".
"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. 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 under-representation of some racial minorities, especially when they may have a relatively high prevalence for a particular drug indication," says Susan G. Kornstein, MD, Editor-in-Chief of Journal of Women's Health, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health.
About the Journal
Journal of Women's Health, published monthly, is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. Led by Editor-in-Chief Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health, the Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women's healthcare issues. Complete tables of content and a sample issue may be viewed on the Journal of Women's Health website. Journal of Women's Health is the official journal of the Academy of Women's Health and the Society for Women's Health Research.
About the Academy
Academy of Women's Health is an interdisciplinary, international association of physicians, nurses, and other health professionals who work across the broad field of women's health, providing its members with up-to-date advances and options in clinical care that will enable the best outcomes for their women patients. The Academy's focus includes the dissemination of translational research and evidence-based practices for disease prevention, diagnosis, and treatment of women across the lifespan.
About the Publisher
Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including LGBT Health, Transgender Health, Population Health Management, and Breastfeeding Medicine. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.
Mary Ann Liebert, Inc. 140 Huguenot Street, New Rochelle, NY 10801 http://www.