Working Together to Address Women's Health in Research and Drug Development: Summary of the 2017 Women's Health Congress Preconference Symposium

Irwin M Feuerstein; Marjorie R Jenkins; Susan G Kornstein; Michael S Lauer; Pamela E Scott; Tonse N K Raju; Tamara Johnson; Stephanie Devaney; Milena Lolic; Marsha Henderson; Janine Austin Clayton

doi:10.1089/jwh.2018.29019.pcss

Working Together to Address Women's Health in Research and Drug Development: Summary of the 2017 Women's Health Congress Preconference Symposium

J Womens Health (Larchmt). 2018 Oct;27(10):1195-1203. doi: 10.1089/jwh.2018.29019.pcss.

Affiliations

¹ 1 Office of Research on Women's Health, National Institutes of Health , Bethesda, Maryland.
² 2 Office of Women's Health , U.S. Food and Drug Administration, Silver Spring, Maryland.
³ 3 Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University , Richmond, Virginia.
⁴ 4 Office of Extramural Research, National Institutes of Health , Bethesda, Maryland.
⁵ 5 Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health , Bethesda, Maryland.
⁶ 6 Center for Drug Evaluation and Research , U.S. Food and Drug Administration, Silver Spring, Maryland.
⁷ 7 All of Us Research Program, National Institutes of Health , Bethesda, Maryland.

Abstract

Historically, women have been underrepresented in clinical research, requiring physicians to extrapolate medical recommendations for women from clinical research done in cohorts consisting predominantly of male participants. While government-funded clinical research has achieved gender parity in phase-3 clinical trials across many biomedical disciplines, improvements are still needed in several facets of women's health research, such as the inclusion of women in early-phase clinical trials, the inclusion of pregnant women and women with physical and intellectual disabilities, the consideration of sex as a biological variable in preclinical research, and the analysis and reporting of sex and gender differences across the full biomedical research continuum. The National Institutes of Health (NIH) Office of Research on Women's Health and the Office of Women's Health of the U.S. Food and Drug Administration (FDA) cosponsored a preconference symposium at the 25th Annual Women's Health Congress, held in Arlington, VA in April, 2017, to highlight gains made and remaining needs regarding the representation of women in clinical research, to introduce innovative procedures and technologies, and to outline revised policy for future studies. Six speakers presented information on a range of subjects related to the representation of women in clinical research and federal initiatives to advance precision medicine. Topics included the following: the return on investment from the NIH-funded Women's Health Initiative; progress in including women in clinical trials for FDA-approved drugs and products; the importance of clinical trials in pregnant women; FDA initiatives to report drug safety during pregnancy; the NIH-funded All of Us Research Program; and efforts to enhance FDA transparency and communications, including the introduction of Drug Trials Snapshots. This article summarizes the major points of the presentations and the discussions that followed.

Keywords: clinical trial; drug development; precision medicine; pregnancy; women.

Publication types

Congress

MeSH terms

Biomedical Research* / economics
Biomedical Research* / ethics
Biomedical Research* / standards
Clinical Trials as Topic* / economics
Clinical Trials as Topic* / ethics
Clinical Trials as Topic* / standards
Drug Development / organization & administration*
Female
Financial Management / methods
Humans
Needs Assessment
Patient Selection*
Pregnant Women
Quality Improvement
Sexism / prevention & control*
United States
Women's Health*