Enrollment of Women in Clinical Research at Mass General Brigham

Aleta Wiley, MPH, MSc
Department of Connors Center for Women’s Health and Gender Biology
Poster Overview

Background: Historically, women were under-represented in medical research. Recently, many institutions have focused on increasing female participation. We assessed participation of women in clinical studies at Mass General Brigham (MGB).

Methods: We obtained reports of the numbers of women and men who participated in MGB Institutional Review Board-monitored studies of adults over the past 5 years. Average proportions of women in these studies are described by health area.

Results: Of 2,191 protocols identified [including 1,161,052 participants], 90.1% intended to enroll both women and men. Of these, 90.3% succeeded in enrolling both sexes/genders. The average percentage of women enrolled was 50.3%. Percentages of women varied by health area, with some areas having higher percentages of women (e.g. pregnancy, 82.5%; auto- immune, 65.8%) and others having lower percentages of women (e.g. cardiovascular, 39.8%; transplantation, 38.0%; burns, 34.2%). 8.8% protocols intended but failed to enroll both sexes/genders. 9.5% of protocols only intended to enroll one sex/gender [female (8.0%); male (1.5%)].

Conclusions: Similar numbers of women and men have participated in clinical studies at MGB. The percentage of women enrolled varies by health area.

Scientific Abstract

Background: Recently, many institutions have focused on increasing female participation in clinical research given historical under-enrollment of women. We assessed enrollment of women in clinical protocols at Mass General Brigham (MGB).

Methods: Enrollment data stratified by sex/gender were extracted for all completed intervention/interaction protocols under the MGB IRB jurisdiction that enrolled 10+ adults and had an annual Continuing Review approved 3/18/15–3/18/2020. Mean proportions of women enrolled are described by therapeutic focus.

Results: Of 2,191 protocols identified [n=1,161,052 participants], 1,974 (90.1%) intended to enroll both women and men. Of these, 90.3% succeeded in enrolling both sexes/genders. The mean proportion of women enrolled was 50.3% (SD: 18.7). Proportions of women varied by therapeutic focus of the protocol, with some skewing female (e.g. pregnancy, 82.5%; auto- immune, 65.8%) and others skewing male (e.g. cardiovascular, 39.8% female; transplantation, 38.0%; burns, 34.2%). Another 192 (8.8%) protocols intended but failed to enroll both sexes/genders. The remaining 9.5% of protocols only intended to enroll one sex/gender [female (8.0%); male (1.5%)].

Conclusions: Female enrollment in clinical studies at MGB is robust, with variation by therapeutic focus. Future analyses will examine how the variation matches the burden of disease in the population.

Clinical Implications
Including women in clinical research across all therapeutic areas where sex- and gender-based factors may affect results is vital to assure that translational solutions for developing diagnostics and therapeutics are applicable to both women and men.
Research Areas
Authors
Aleta Wiley, MPH; Monica Bennett Fonseka, MS; Alexandra Z. Sosinsky, MS; Janet Rich- Edwards, ScD, MPH; Kalifa Wright, MPH; Julie Alperen, DrPH; Primavera Spagnolo, MD, PhD; Hadine Joffe, MD, MSc
Principal Investigator
Hadine Joffe, MD MSc

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