Women in Clinical Trials: National Analysis of ClinicalTrials.gov 2016-2019

Alexandra Sosinsky, MSc
Department of Medicine & Women’s Health
Division of Pharmacoepidemiology and Pharmacoeconomics
Poster Overview

Background: Historically, women have been underrepresented in clinical trials evaluating drugs and medical devices. We assessed women’s participation in recent clinical trials.

 

Methods: ClinicalTrials.gov is a web-based registry of clinical trials performed in the US. We extracted data for drug and medical device trials conducted in three therapeutic areas: cardiovascular, neuropsychiatric, and cancer. Only studies that allowed both sexes to participate were included. The results describe the percentage of women enrolled by therapeutic area.

 

Results: Across 1,433 trials including 302,664 participants, on average, 41.2% were female. Given that 51% of patients with cardiovascular disease are female, trial populations including 41.9% (95% CI 35.9-47.9%) women did not adequately reflect the population with the disease. In neuropsychiatry, where women comprise 61% of patients, women’s mean participation in trials was 42.0% (95% CI 36.3-47.7%). Similarly, for cancer, where 49% of patients are female, only 41.0% of cancer trial participants were female (95% CI 37.9-44.1%).

 

Conclusions: Women’s participation in clinical trials has improved over time. However, gender gaps still remain between trial populations and those expected to use these drugs/devices based on the population-level distribution of diseases. Given differences in treatment responses between men and women, adequate inclusion of women in trials remains critical.

Scientific Abstract

Background: Historically, women have been underrepresented in clinical trials evaluating efficacy and safety of investigational drugs/devices. We assessed women’s participation in recent trials.

 

Methods: 2016-2019 ClinicalTrials.gov data on US-based, industry or government-funded Phase 1-3 clinical trials of drugs and devices were extracted. We included trials with adult cardiovascular, neuropsychiatric and cancer endpoints whose protocol allowed both sexes to participate. Average proportions of women enrolled were described by disease area.

 

Results: Across 1,433 trials including 302,664 participants, on average, 41.2% were female. Given that 51% of patients with cardiovascular disease are female, trial populations including 41.9% (95% CI 35.9-47.9%) women did not adequately reflect the population with the disease. In neuropsychiatry, where women comprise 61% of patients, women’s mean participation in clinical trials was 42.0% (95% CI 36.3-47.7%). Similarly, for cancer, where 49% of patients are female, only 41.0% of cancer clinical trial participants were female (95% CI 37.9-44.1%).

 

Conclusions: Women’s participation in clinical trials has improved compared to historical reports. However, gender gaps still persist between trial populations and those expected to use these drugs/devices based on distributions of diseases in the population. Given sex-based differences in treatment responses and toxicities, adequate inclusion of women in clinical trials remains critical.

Clinical Implications
Based on clinical trial registry data for drugs and devices with cardiovascular, neuropsychiatry, and cancer endpoints, gender gaps still persist between trial populations and those expected to use these drugs/devices based on distributions of diseases in the population.
Research Areas
Authors
Alexandra Z. Sosinsky, MS1,2,3,4; Janet Rich-Edwards, ScD, MPH1,3,6; Aleta Wiley, MPH1,5,6; Kalifa Wright, MPH1; MPH; Julie Alperen, DrPH1; Hadine Joffe, MD, MSc1,5,6
Principal Investigator
Hadine Joffe

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