Disparities persist in clinical trial leadership across specialties
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Key takeaways:
- More representation of women as study participants occurred in trials with female vs. male leadership.
- Researchers observed a significant increase in female principal investigators from 27% in 2005 to 39.6% in 2023.
Although the percentage of female principal investigators in clinical trials has increased in recent years, gender underrepresentation continued to persist, according to a research letter published in JAMA Internal Medicine.
Of note, researchers observed higher rates of the gender gap in late-phase and industry-funded trials.
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“Serving as a principal investigator can lead to professional advancements and prestige, making it a significant career advancement opportunity for physicians,” Ithai Waldhorn, MD, PhD, researcher in the division of oncology at Rambam Health Care Campus, Israel, and colleagues wrote.
Investigators sought to assess representation of women as principal investigators in 245,771 clinical trials. They used Genderize.io to predict gender, the Cochran-Armitage trend test to estimate the association between representation of female principal investigators over time and study phases, and the Wilcoxon rank sum test to evaluate the association between gender of the principal investigator and trial participants.
Female vs. male leadership
Researchers determined the gender for 95.8% of investigators of the clinical trials studied.
Overall, women made up 32.4% of principal investigators compared with men at 63.5%.
Researchers observed the lowest proportions of female principal investigators for clinical trials involving cardiology (20.3%) and hepatology (21.4%), followed by ophthalmology, pulmonology, gastroenterology, urology, hematology-oncology and oncology.
Conversely, researchers observed the highest proportions of female principal investigators for rheumatology (49.2%) and obstetrics-gynecology (43.9%) clinical trials.
Results also showed that significantly fewer women led clinical trials funded by the biomedical industry compared with nonindustry (19.2% vs. 39.5%; OR = 0.38; 95% CI, 0.36-0.4).
Additional results of analysis by study type showed fewer female principal investigators of interventional vs. observational trials (26.8% vs. 32%; OR = 0.78; 95% CI, 0.76-0.8).
Results also showed an association between trial phase and proportion of female principal investigators, with fewer female principal investigators in later-phase trials (phase 1, 28.5%; phase 2, 27.5%; phase 3, 25.9%; and phase 4, 24.7%; P < .001).
Moreover, researchers observed higher representation of women among principal investigators in North America (35.4%) and Europe (30.1%) compared with Asia (26.5%). They also identified more female leadership vs. male leadership in trials with greater representation of women as study participants (52.5% vs. 47.5%; P < .001), which remained true even after excluding gender-specific studies (49.4% vs. 46.4%; P < .001).
Of note, researchers observed a significant increase in the proportion of female principal investigators during the study period from 27% in 2005 to 39.6% in 2023 (P < .001).
Researchers acknowledged study limitations, including that they did not account for the proportions of academic physicians by gender based on period, geographic location or specialty, which may reflect some of the associations observed. Additionally, the researchers noted that they did not explore nonbinary gender but used validated methods to determine gender, and misclassifications may have occurred.
Benchmark data
“These data may serve as a benchmark for women leadership of clinical trials across medicine, identifying covariates and trial subsets associated with differential representation of women,” the researchers wrote. “While the proportion of women leading trials has increased over time, efforts to understand and address underpinnings of disparities in trial leadership are necessary.”
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