Introduction: Clinical trials are considered the gold standard for evaluating the safety and efficacy of new therapies and generating evidence-based guidelines. However, there is growing concern regarding gender inequality at the leadership level. Diversity in clinical trial leadership is associated with more diverse trial participants, which improves the generalizability of results. The objective of this study is to evaluate gender differences in lead authorship among gastroenterology clinical trials registered in the primary clinical trial database, ClinicalTrials.gov.
Methods: We downloaded records of interventional clinical trials registered on ClinicalTrials.gov starting between January 1, 2013 and December 31, 2019. A study set consisting of only gastroenterology and hepatology trials was then created using disease condition terms (both Medical Subject Heading [MeSH] and non-MeSH) from the National Library of Medicine. Records were manually reviewed and verified as relating to either gastroenterology or hepatology. The ClinicalTrials.gov identifier was extracted for each entry and a linked search was performed on PubMed for associated publications. From this study set, the first randomized controlled trial (RCT) was evaluated for lead authorship gender and the publication journal’s impact factor.
Results: 9,705 trials were manually reviewed, from which 4,182 were verified as trials relating to gastroenterology or hepatology. 1,148 trials (27.45%) had results posted as of January 1, 2022, and 462 (11.05%) had an associated publication indexed within PubMed. The gender was determined for 100% of lead authors of published RCTs. The lead author was male in 333 (72.08%) trials and female in 129 (27.92%) trials. The mean impact factor for male first-authored publications was 16.17 ± 1.06, while the mean for female first-authored publications was 18.73 ± 5.55.
Discussion: Women are under-represented as leaders of gastroenterology clinical trials, constituting fewer than 3 in 10 lead authors of gastroenterology trials in the examined study period. The rate of female first-authorship lags behind the broader rate of women entering the field. Recalibration efforts must address the structure and processes that lead to the gender gap in the clinical trial enterprise.
