Understanding and addressing enrollment gaps and opportunities in gynecologic oncology clinical trials: A scoping review.

OBJECTIVE

To identify barriers and facilitators to clinical trial enrollment in patients with gynecologic malignancies, with a focus on disparities related to race, ethnicity, and rurality.

METHODS

We conducted a scoping review following PRISMA guidelines, searching PubMed, Google Scholar, Scopus, Web of Science, ScienceDirect, and Cochrane Library. Search terms targeted clinical trial enrollment, gynecologic cancers, and underrepresentation. We included studies of adult women with gynecologic malignancies that examined factors influencing trial enrollment or participation. Quantitative, qualitative, and mixed-methods studies were all eligible. Findings were synthesized narratively.

RESULTS

Of 152 records identified, 45 studies met inclusion criteria, collectively representing over 2 million patients. Most were retrospective (n = 23), conducted in the United States (n = 43), and published between 2021 and 2025. Across studies, racial and ethnic minority patients were less likely to be enrolled in clinical trials. Rural residence emerged as an independent barrier in 21 studies. The barriers most cited were race, restrictive eligibility criteria, language, limited patient knowledge of trials, insufficient research personnel, and gaps in provider cultural competence. Only seven studies described interventions to improve enrollment including research navigators, behavioral interventions, and community outreach.

CONCLUSION

Enrollment disparities in gynecologic oncology trials remain a persistent problem, shaped by overlapping factors at the patient, provider, and system levels. Notably, when structural barriers are removed, underrepresented patients enroll at rates like their peers, pointing to access as the core issue rather than patient interest or willingness. Prospective studies testing targeted interventions, trial designs that reflect the actual patient population, and sustained investment in research navigation programs are needed.