Participation of Women in Clinical Trials of Drug Therapies: A Context for the Controversies

Marianne N. Prout, MD, MPH, Susan S. Fish, PharmD, MPH

Disclosures
In This Article

Abstract and Introduction

Women's participation in clinical trials, particularly those involving drugs, has been said to be both overrepresented and underrepresented. How can this be? Studies of participation are compared and contrasted to elucidate some reasons for this contradiction. The history of women's participation in clinical trials is chronicled through policies and regulations filled with restrictions. Since 1993, however, the National Institutes of Health has mandated, and the Food and Drug Administration has emphasized, inclusion of women in clinical trials, only to be thwarted by other regulations excluding many women. Gender-specific analyses are required to detect gender differences in effects of pharmaceutical and nonpharmaceutical interventions, but they are seldom performed. The exclusion of women from clinical trials means that women's healthcare is compromised by lack of sex-specific information about dosing of drugs and unique uses of drugs. A database, although currently quite limited, tracks the participation of women in clinical trials funded by federal agencies, industries, and nonprofit groups. Federal regulations have recently changed. Additional changes in access to all phases of clinical trials and enhanced monitoring of clinical trials are recommended.

Have women achieved adequate access to clinical research? Are women adequately represented in clinical trials? What does adequate representation of women mean and require? As debate continues on the pros and cons of sex-based vs sex-neutral healthcare and research, many wonder -- why is there so much controversy?[1,2]

In this overview we present some of the conflicting data on the adequacy of women's participation in clinical trials, particularly trials of drug therapies. (Women's participation in clinical trials of medical devices, biologic therapeutic agents, behavioral interventions, and other nondrug interventions will be reviewed separately.) We discuss the ways in which women's participation in clinical trials was restricted in the past. We summarize specific changes in policies and regulations that aim to equalize opportunities for participation in clinical research. We highlight the emerging fields of research on sex differences. Throughout this article we will use the term sex rather than gender to emphasize our orientation to the biologic bases for attention to the participation of women in clinical trials. This terminology is compatible with the recommendations from the recent Institute of Medicine report that urges research into sex differences from "womb to tomb" and from cell to society.[3] This report differentiates sex from gender as follows: "Sex refers to the classification of living things, generally as male or female according to their reproductive organs and functions assigned by chromosomal complement. Gender refers to a person's self-representation as male or female, or how that person is responded to by social institutions based on the individual's gender presentation. Gender is rooted in biology and shaped by environment and experience."

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