Global sex-based disparities in pancreatic cancer clinical trial enrollment: A systematic review and meta-analysis.

Abstract

1654 Background: Sex-based disparities in oncology trial enrollment are well recognized, yet their magnitude and consistency in pancreatic cancer clinical trials remain poorly-defined. We conducted a global systematic review and meta-analysis to quantify women’s representation in pancreatic cancer trials relative to disease incidence. Methods: We identified phase I–III randomized and prospective interventional pancreatic cancer trials published through November 2025 in the top 25 general medicine, oncology, and gastroenterology journals. Women’s enrollment was compared with sex-specific pancreatic cancer incidence from Global Burden of Disease estimates. Enrollment disparity difference (EDD) was calculated as the proportion of women enrolled minus the proportion of women in the underlying disease population. Random-effects meta-analyses, subgroup analyses, and temporal meta-regression were performed. Results: Among 191 eligible trials including 37,688 participants, 16,393 (43.5%) were women. Overall, women were significantly under-enrolled, with a pooled EDD of −0.050 (95% CI, −0.058 to −0.042). Under-enrollment was observed across all geographic regions, with the largest disparity in European trials (EDD −0.069; 95% CI, −0.080 to −0.058). Significant disparities were present across all trial phases except combined phase I/II studies and were most pronounced in trials enrolling fewer than 50 participants (EDD −0.081; 95% CI, −0.105 to −0.057). Women remained under-enrolled across chemotherapy, immunotherapy/biologic, vaccine, and multimodal trials, while no significant disparity was observed in radiotherapy studies. Trials with women in leadership roles demonstrated slightly attenuated but persistent under-enrollment (EDD −0.046 vs −0.052). Temporal analyses showed narrowing of disparities between 2016 and 2020, followed by worsening under-enrollment from 2021 to 2025 (EDD −0.033). Sensitivity analyses limited to chemotherapy, immunotherapy/biologic, and phase III trials confirmed consistent patterns of under-representation. Conclusions: Women are persistently under-enrolled in pancreatic cancer clinical trials worldwide, with disparities evident across regions, trial phases, and treatment modalities. Recent reversals in progress highlight the need for durable, equity-focused trial design and enrollment strategies.