‘Diversity in trial leadership is key’ to reflect broader physician community
Key takeaways:
- Clinical trials published in high-impact journals included low rates of women as first and last authors.
- Researchers observed similar rates of women as first and last authors in Europe and North America.
Data showed a lower likelihood for women as first and last authors of oncology clinical trials in industry-sponsored and high impact journals, according to study results presented at ASH Annual Meeting and Exposition.
The results reflect gender bias in publishing and call for global efforts to address the imbalance in clinical trial leadership, researchers concluded.
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Impact
“Clinical trial leadership impacts development opportunities, career progression and research funding,” Richa Manwani, MD, researcher and hematologist at Alexion, AstraZeneca in London, and colleagues wrote. “Diversity in trial leadership is key to widening experience with novel agents and ensuring reflection of the broader physician community. Women are underrepresented as lead investigators in phase 3 oncology trials, particularly industry-led trials.”
Researchers sought to examine the representation of women as leaders of hematology-oncology clinical trials. They searched the PubMed database for phase 1 to phase 3 clinical trials on myeloma, lymphoma and leukemia published in 2021 and identified gender of authors based on pronouns, photographs and presentation of self on professional/social profiles. The proportion of women as first and last authors served as the primary outcome.
Researchers estimated and compared the odds ratios for female vs. male authorship according to sponsorship and journal impact factor.
Representation of women
Among the 444 clinical trials analyzed (industry-sponsored, 44.6%; academic, 55.2%; unknown, 0.2%), researchers observed a lower likelihood for women as first authors (35.1%) and last authors (19.8%).
Results specifically showed women as first authors in 29.3% of industry-sponsored trials and in 40% of academic trials.
Researchers also observed a 1.6-times odds for women as first authors in academic trials compared with industry trials (95% CI, 1.08-2.4) and a 1.3-times odds for women as final authors in academic trials vs. industry trials (95% CI, 0.8-2.08).
Moreover, they found a higher likelihood for women as first authors in leukemia trials (41.2%), followed by lymphoma (34%) and myeloma (31.4%), and a higher likelihood for women as last authors in 22.7% of myeloma trials, followed by lymphoma (18.9%) and leukemia (16%).
Further, the highest proportion of women as first authors occurred in phase 1 trials (42%), followed by phase 2 (35%) and phase 3 (33.6%). Whereas the highest proportion of women as last authors occurred in phase 3 trials (22.4%), followed by phase 2 (19.8%) and phase 1 trials (17.9%).
Data on geographic location showed the highest rate of women as first authors in Australasia (38.9%), followed by Europe and North America (34.9% for both) and Asia (32.5%). Researchers observed the highest rates of women as last authors in Europe (22.2%), followed by North America (20.2%), Australasia (15.8%) and Asia (10%).
Of note, results showed a 1.5-times odds for women as first authors in low-impact factor journals vs. high-impact journals (95% CI, 1.01-2.23), and women as last authors in 20.4% of low-impact journals and in 19.2% of high-impact journals.
For the 13 clinical trials published in two of the highest impact journals, most were industry-sponsored (92.3%) and 15.4% included women as first authors and 15.4% included women as last authors.
Observed bias
“To our knowledge, this is the first study to assess the representation of women as leaders of hematology-oncology clinical trials,” Manwani and colleagues wrote.
“A third of trials had a female first author and one-fifth had a female final author,” they added. “Female first authorship was significantly lower among industry-sponsored trials compared with academic trials, possibly reflecting gender bias in the interface between industry and academia.”
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Manwani R, et al. Abstract 2439. Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2024; San Diego.
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