Unnecessary exclusions: eligibility criteria in gynecologic oncology interventional clinical trials impairs access.

Abstract

Objective: This study aimed to assess the eligibility requirements in gynecologic oncology clinical trials that may impair patient access to clinical trials.

Methods: Using clinicaltrials.gov, gynecologic oncology interventional studies conducted between September 1, 1997 and September 1, 2023 were surveyed. Studies were included if they were interventional and conducted in the United States, with available protocols. Differences in means were estimated, and hypothesis testing was conducted under the general framework for bimodal logistic regression or paired t tests where appropriate.

Results: Of the 606 included interventional clinical trials, 256 (42.2%) were for uterine cancer, 99 (16.3%) for ovarian, fallopian tube or peritoneal cancer, 55 (9.1%) for cervical cancer, and 197 (32.5%) involved multiple gynecologic oncology cancers. Of all eligible clinical trials, 351 (57.9%) had an exclusion criterion based on renal function, 206 (34.0%) had a diagnosis of human immunodeficiency virus, 194 (32.0%) had a mental health or psychiatric condition, and 170 (28.1%) had an exclusion criterion based on investigator discretion. Renal exclusion was more likely in clinical trials for uterine cancer (p = .04). Exclusion based on investigator decision was more likely in uterine cancer (p = .001) and ovarian cancer trials (p = .007) than in cervical cancer trials.

Conclusions: The most frequent exclusion criteria in gynecologic oncology clinical trials were based on renal function, followed by diagnosis of human immunodeficiency virus status and diagnosis of psychological/mental illness. Our study emphasizes the importance of understanding eligibility requirements of clinical trials to increase access to clinical trials for all patients.