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Gender differences in clinical registration trials: is there a real problem?
Geert Labots1, Aubrey Jones1, Saco J de Visser2
1Centre for Human Drug Research, Leiden, The Netherlands.
British Journal of Clinical Pharmacology
|January 3, 2018
Summary
This study found no systematic under-representation of women in clinical trials for drug registration. Female participation varied by trial phase, with lower numbers in Phase I compared to later phases.
Area of Science:
- Pharmacology and Clinical Research
- Drug Development and Regulation
- Gender Health Disparities
Background:
- Previous research indicates women are under-represented in clinical trials, potentially impacting drug safety and efficacy assessments.
- This under-representation raises concerns about the external validity of benefit/risk profiles for approved medications.
- Understanding gender participation in clinical trials is crucial for equitable drug development.
Purpose of the Study:
- To assess the inclusion rates of women in clinical trials supporting drug registration.
- To analyze the proportion of female participants across different trial phases (I, II, and III).
- To compare trial participant demographics with disease prevalence data to identify potential disparities.
Main Methods:
- A cross-sectional analysis of publicly available registration dossiers for frequently prescribed Food and Drug Administration (FDA)-approved drugs.
- Inclusion of compounds with high hepatic clearance and known gender-specific drug responses.
- Sensitivity analysis comparing trial data with US disease prevalence statistics.
Main Results:
- Data from 38 (28%) of 137 drugs revealed 185,479 participants: 47% female, 44% male, with 9% unreported gender.
- Female participation significantly differed by trial phase: 22% in Phase I versus 48% in Phase II and 49% in Phase III.
- Ten drugs (26%) showed a >20% disparity between female disease prevalence and trial representation.
Conclusions:
- Analysis of publicly available data did not reveal systematic under-representation of women in clinical trials for drug registration.
- While overall representation appeared adequate, phase-specific analysis highlighted lower female participation in early-phase trials.
- Discrepancies between disease prevalence and trial inclusion warrant further investigation for specific drugs.
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