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Analysis of Female Participant Representation in Registered Oncology Clinical Trials in the United States from 2008

Nirosha D Perera1, Tiffany R Bellomo2, Walker M Schmidt3

  • 1Department of Medicine, Mayo Clinic, Rochester, MN, USA.

The Oncologist
|February 27, 2023
PubMed
Abstract

Insights

Female underrepresentation persists in US oncology trials, particularly in surgical interventions and certain cancer sites. Hematologic, pancreatic, and industry-funded trials show better female representation, offering models for improvement.

Area of Science:

  • Oncology
  • Clinical Trials
  • Health Disparities

Background:

  • Female underrepresentation in oncology clinical trials can lead to disparities in treatment outcomes.
  • Evaluating female participant representation across different trial types, cancer sites, and funding sources is crucial.

Purpose of the Study:

  • To assess the extent of female participant representation in US oncology clinical trials.
  • To identify factors associated with proportional female representation, including intervention type, cancer site, and funding source.

Main Methods:

  • Data from 1650 US oncology trials (240,776 participants) were analyzed using the Aggregate Analysis of ClinicalTrials.gov database.
  • The participation-to-prevalence ratio (PPR) was calculated to compare female representation in trials versus the general disease population.
  • Statistical analyses, including odds ratios (OR) and 95% confidence intervals (CI), were used to determine significant associations.

Main Results:

  • Overall, females constituted 46.9% of trial participants, with a mean PPR of 0.912, indicating slight underrepresentation.
  • Underrepresentation was noted in surgical (PPR 0.74) and other invasive trials (PPR 0.69).
  • Specific cancer sites like bladder, head/neck, stomach, and esophageal trials showed significant female underrepresentation, while hematologic and pancreatic trials had higher proportional representation. Industry-funded trials demonstrated greater proportional female representation compared to government or academic-funded trials.

Conclusions:

  • Hematologic, pancreatic, and industry-funded oncology trials serve as positive examples for achieving proportional female participant representation.
  • Stakeholders should consider these exemplars and the implications of female representation when interpreting clinical trial results to ensure equitable outcomes.
Keywords:
female participant representationoncology clinical trialsparticipation to prevalence ratio

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