Trends in phase 3 gynecological clinical trials of targeted therapies: Study oversight and pharmaceutical involvement in the past 12 years.

5503 Background: To determine the trends, progress, and pharmaceutical sponsorship of clinical trials in targeted therapy treatments for gynecologic cancers. Methods: From January 1st, 2011, to May 31st, 2023, all phase III gynecological clinical trials in targeted therapy treatment were identified from clinicaltrials.gov and reviewed using peer review publications. Characteristics of demographics and authorship were analyzed for comparison using Chi-square analyses and Fisher’s exact tests. P-values <0.05 were considered statistically significant. Results: Over the 12-year period, we identified 18,424 patients enrolled across 30 clinical trials studying targeted therapy treatments for gynecologic cancers. Of these trials, 86.7%, 10.0%, and 3.3% involved ovarian, cervical, and endometrial cancers, respectively. Of patients enrolled in these trials, 77.0% identified as White, 13.3% as Asian, and 2.4% as Black; only 3.0% identified as Hispanic. Approximately 46.7% of first authors of publications for these trials were from the U.S. and 43.3% were from Europe. Furthermore, 23.4% of co-authors served or consulted on a committee board, 15.2% received grants/honoraria, and 10.0% were pharmaceutical employees. 73.3% of dedicated medical writers were funded by pharmaceutical groups. Additionally, 83.3% of trials were led by the pharmaceutical industry while 16.7% mainly funded by cooperative groups. 70.0% of clinical trials employed pharmaceutical group funding for study design, and 66.7% of trials had data analyzed by pharmaceutical groups. Clinical trials were then divided into three time periods based on time of publication (2011-2015, 2016-2019, and 2020-2023). Over these periods, diverse patient enrollment increased. There were statistically significant decreases in the proportion of White (80.7% vs. 82.6% vs. 70.3%; p<0.0001) and Black (2.8% vs. 2.5% vs. 2.1%; p<0.0001) patients while increases were found among Asians (6.4% vs. 10.3% vs. 20.5%; p<0.0001) and Hispanics (2.3% vs. 0.7% vs. 12.3%; p<0.0001). The proportion of authors receiving grants/honoraria support increased from 8.0% to 14.2% to 18.2% (p<0.0001). Authors serving as industrial employees rose from 6.3% to 7.1% to 13.1% (p=0.02). Conversely, the proportion of authors acting as pharmaceutical advisory board members or consultants changed from 31.3% to 30.1% to 16.5% (p<0.0001). However, authors without pharmaceutical affiliation remained stable at 49.1% to 53.6% to 48.9% (p=0.004). Conclusions: The number of trials over the last 12 years sponsored by industry increased, as well as pharmaceutical employee participation and grant support. Additionally, Asian and Hispanic participant enrollment significantly increased. Balancing the benefits of pharmaceutical partnership with study oversight and disclosure is important in protecting the interests of our patients.