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Gender representation in trials.

C L Meinert1, A K Gilpin, A Unalp

  • 1Center for Clinical Trials, The Johns Hopkins University, School of Hygiene and Public Health, Baltimore, MD 21205, USA. cctmail@jhsph.edu

Controlled Clinical Trials
|October 6, 2000
PubMed
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This study found no evidence of systematic bias against females in clinical trial research. Analysis of trials published between 1966 and 1998 indicates women were not understudied compared to men.

Area of Science:

  • Medical research methodology
  • Clinical trial design
  • Gender-based health disparities

Background:

  • A common perception exists that women are underrepresented in clinical research compared to men.
  • Legislation was enacted requiring clinical trials to provide valid analysis of gender-specific effects.
  • This study investigated the factual basis for the perception of underrepresentation.

Purpose of the Study:

  • To evaluate gender-based research effort in clinical trials.
  • To determine if women have been systematically understudied in medical research.
  • To assess the validity of the perception of gender bias in clinical trials.

Main Methods:

  • Analysis of clinical trials published in U.S. journals between 1966 and 1998, indexed in MEDLINE.

Related Experiment Videos

  • Classification of trials by gender representation (males and females, males only, females only, unspecified).
  • Quantitative analysis of male and female participant counts in selected high-impact medical journals in 1985, 1990, and 1995.

    • Main Results:

    • In U.S. journal publications (1966-1998), 55.2% of trials included both genders, 12.2% included males only, 11.2% included females only, and 21.4% did not specify gender.
    • In five major medical journals (1985, 1990, 1995), counts showed 355,624 males and 550,743 females represented in trial reports.
    • The data did not support a finding of systematic research effort bias against females.

    Conclusions:

    • The perception of systematic underrepresentation of women in clinical trials lacks empirical support based on this analysis.
    • Published clinical trial data from 1966-1998 does not indicate a bias against the inclusion of female participants.
    • Further research may be needed to explore nuances beyond overall counts, but initial findings do not confirm gender bias in research effort.