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[Women in clinical trials]
M J Gérard-Coué1, G Bréart, A Spriet
1Laboratoires SANDOZ, Rueil-Malmaison, France.
Therapie
|July 1, 1995
Summary
Women should be included in clinical trials to reflect disease prevalence. Researchers recommend studying gender impacts on trial outcomes for better drug development.
Area of Science:
- Clinical pharmacology
- Medical research methodology
Context:
- A 1994 workshop convened drug company representatives and scientists to address women's inclusion in clinical trials.
- Discussions focused on ethical and scientific considerations for equitable participant representation.
Purpose:
- To establish recommendations for the inclusion of women in clinical trials.
- To ensure clinical trial data accurately reflects diverse patient populations.
Summary:
- Recommendations were made for phase II and III studies to include men and women in proportions mirroring disease prevalence.
- Systematic investigation into the impact of gender on study results was advised.
Impact:
- Aims to improve the generalizability and applicability of clinical trial findings across genders.
- Promotes more precise and effective therapeutic strategies by considering sex-based differences.