Study Design Factors May Impact Enrollment in Gynecologic Cancer Trials

An objective manual screening process may enhance diversity in gynecologic cancer clinical trial enrollment, according to a study being presented at the 2024 American Society of Clinical Oncology Annual Meeting.

Researchers sought to “evaluate trial enrollment trends according to patient and trial demographics for those who have sought care at our multicenter, mixed-setting gynecologic oncology practice” and aimed to “determine specific trial criteria that promote or impede enrollment for patients and physicians.”

In this retrospective, cohort study, researchers assessed patients who screened positive for a clinical trial through a manual screening process at a gynecologic oncology practice. Screening events of interest were new neoplasms, recurrences or progressions, and changes in treatment. They recorded demographic information, as well as trials for which each patient was considered, trials patients enrolled on, and trial characteristics. Data collection was conducted from July 2022 to December 2023.

The findings showed that there were no notable differences between patient factors (age, marital status, race, ethnicity, and number of screening events) and enrollment status. Of trials available, the researchers observed that 9.0% require biopsy and 94.7% are in person. Also, most studies are interventional (approximately 79.0%) and pharmaceutical trials (73.7%). The investigators noted that were was a drastic unadjusted estimated increase in enrollment for Medicaid patients compared with other insurances (55.2% vs 32.0%; P=.031).

Moreover, the study showed increased enrollment for cervical cancer patients (18.4%; P=.106) compared with other cancer sites (56.5% vs 32.8%; P=.036). The researchers further noted that there was a positive relationship between distance traveled to the treatment site and clinical trial enrollment. They observed that patients who resided within 20 miles of the clinical trial site had an enrollment percentage of 30.10% (n=93) compared with 46.55% enrollment for those who lived further away (n=58). There was a significant increase in enrollment likelihood without an exclusion criterion of previous history of other cancer (50.0% vs 33.3%; P=.046). Trials that required no history of chemotherapy had an enrollment of 27.3% compared with 44.1% in those that required a history of chemotherapy treatment.

“Unlike prior reports, we did not demonstrate differences in trial enrollment by race, socioeconomic or insurance status. This suggests that our objective manual screening process enhances equitable clinical trial offerings. It is possible that this objective manual screening process attenuates provider bias and offers clinical trials to historically marginalized and underrepresented groups,” the researchers concluded.

Reference

Pirzadah H, Klein M, Magharehabed Y, Chapple A, Castellano T, Jernigan A. PENTAGON (Predicting Clinical Trials in Gynecologic Oncology): a retrospective study assessing study design factors that affect enrollment in gynecologic cancer trials. Abstract #e13647. Published for the 2024 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024; Chicago, Illinois.