The evolving landscape of academic and industry partnerships in gynecologic oncology clinical trials.

Abstract

9038 Background: To determine trends in the financial relationships of study investigators in gynecologic oncology trials. Methods: From 2011-2024, phase III trials were identified from clinicaltrials.gov. Data was collected from the conflict-of-interest (COI) statements of 54 clinical trials. Chi-square and Fisher's exact tests were used for statistical analysis. Results: Of1,390 total co-authors from 54 clinical trial publications, we found that 46.3% of authors were from European nations, 28.3% were based in the United States, and 16.9% were from East Asian nations, with the remaining 8.5% from other nations (including, but not limited to, Australia, Canada, and Mexico). Of the listed authors’ titles, 82.8% held MDs and 17.2% held non-MD degrees (PHD, MPH, MSc). Most (74.0%) of the trials were on ovarian cancer, with the remainder being on cervical (13.0%) and endometrial (13.0%) cancer. The majority (79.5%) of trials were sponsored by pharmaceutical companies, while the remainder were academic/cooperative-led trials. Among the pharmaceutical and industry sponsors, Roche / Genentech sponsored the most trials (27.8%), followed by Merck Sharp & Dohme (16.7%) and AstraZeneca (14.8%). Overall, 61.8% of total authors had some form of COI; of the total authors, 40.9% were consultants, 29.1% received research funding, 9.6% attended speaker bureaus, 18.6% received travel funds, and 9.8% declared employment/stock ownership. In all trials, the majority of authors disclosed COI regardless of if the trial was pharmaceutical or cooperative-led, at 63.5% and 55.2%, respectively. To evaluate trends, we divided the data into three time periods, 2011-2015, 2016-2019, and 2020-2024. Over time, there was a statistically significant increase in the number of authors who were consultants: 27% to 40% to 44% (p<0.001); who received research funding: 16% to 25% to 33% (p<0.0001); and who received travel funds: 8% to 19% to 20% (p<0.01). There was no change in speaker bureau participation (p=0.63) or employment/stock ownership (p=0.20). Conclusions: Financial relationships between study investigators and pharmaceutical companies have increased, particularly in consulting and research funding. As industry involvement grows, academic cooperative groups should maintain close collaboration to ensure scientific integrity and guide trial design.