Representation of Women As Leaders of Hemato-Oncology Clinical Trials

Background Clinical trial leadership impacts development opportunities, career progression and research funding. Diversity in trial leadership is key to widening experience with novel agents and ensuring reflection of the broader physician community. Women are under-represented as lead investigators in Phase 3 oncology trials, particularly industry-led trials (Ludmir et al, JAMA Onc 2019). We examined the representation of women as leaders of Hemato-Oncology trials. Methods We performed a PubMed search of Phase 1-3 myeloma, lymphoma and leukemia trials published in 2021. Details of first and final author, country, sponsor, impact factor and study phase were collected. Gender of authors was identified based on pronouns, photographs and presentation of self on professional/social profiles. The primary outcome measure was the proportion of female first and final authors. The odds ratios of female compared to male authorship were estimated, with respect to sponsorship and journal impact factor. Results A total of 444 clinical trials were analyzed; 156 (35.1%) had a female first author and 88 (19.8%) had a female final author. Sponsorship was as follows: industry 44.6%, academic 55.2%, unknown 0.2%. The proportion of female first authorship in industry-sponsored and academic trials was 29.3% and 40%, respectively. The odds of female first authorship in an academic trial were 1.6 times that of an industry trial (p=0.02, 95% CI:[1.08, 2.40]). The proportion of female final authorship was 17.7% in industry trials and 21.6% in academic trials; the odds of female final authorship in an academic trial were 1.3 times that of an industry trial (p=0.30, 95% CI:[0.80, 2.08]). The number of myeloma, lymphoma and leukemia trials was 172, 141 and 132, respectively. The proportion of female first authorship among these was 31.4%, 34.0% and 41.2%, and proportion of female final authorship was 22.7%, 18.9% and 16.0%, respectively. Female first authorship among Phase 1, 2 and 3 trials was 42.0%, 35.0% and 33.6%; the proportion of female final authorship was 17.9%, 19.8% and 22.4%, respectively. First authors were in: Asia 9.0%, Australasia 4.1%, Europe 33.6%, North America 52.9% and South America 0.4%. The rate of female first authorship was 32.5% in Asia, 38.9% in Australasia, 34.9% in Europe, 34.9% in North America and 0% in South America. Of final authors, 9.0% were in Asia, 4.3% in Australasia, 37.6% in Europe and 49.1% in North America. The rate of female final authorship was 10% in Asia, 15.8% in Australasia, 22.2% in Europe and 20.2% in North America. The median journal impact factor was 11 (range 0.5 to 168). Of trials in journals with impact factor ≤11 (lower impact factor), female first authorship comprised 39.6% compared to 30.4% in journals with impact factor>11 (higher impact factor). The odds of female first authorship of trials published in a lower impact factor journal were 1.5 times that of a higher impact factor journal (p=0.043, 95% CI: [1.01, 2.23]). Female final authorship was similar in lower (20.4%) and higher impact factor (19.2%) journals, (p=0.74). Of 13 trials published in the two highest impact factor journals, 12 (92.3%) were industry-sponsored trials; 2/13 (15.4%) had a female first author and 2/13 (15.4%) had a female final author. Discussion To our knowledge, this is the first study to assess the representation of women as leaders of Hemato-Oncology clinical trials. A third of trials had a female first author and one-fifth had a female final author. Female first authorship was significantly lower among industry-sponsored trials compared to academic trials, possibly reflecting gender bias in the interface between industry and academia. Women were less likely to be first authors in higher impact journals. Clinical trials published in the highest impact journals were predominantly industry-sponsored and had particularly low female first/final authorship rates (15.4%). Female final authorship was disappointingly low across both industry-sponsored and academic trials. In general, the majority of first and final authors were in Europe and North America, and rates of female authorship appeared similar in these regions. Global efforts to understand and address imbalance in trial leadership are crucial.