Michael T Richardson, Danika Barry, Jecca R Steinberg, Kai Holder, Vineeth Thirunavu, Naixin Zhang, Brandon E Turner, Christopher J Magnani, Anna Marie P Young, Connie F Lu, Natalie A Squires, Jill N Anderson, Joshua Cohen, Beth Y Karlan, John K Chan, Daniel S Kapp, Dario R Roque, Ritu Salani
In clinical trials in gynecologic oncology, early-phase trials were more likely to reach publication than late-phase trials. While late-phase trials were more likely to report race/ethnicity data compared to early-phase trials, early-phase trials were more likely to enroll REMGs. Further research must be conducted to determine reasons for the overall low publication rates of gynecologic oncology trials and relative under-enrollment of REMGs in late-phase trials, in order to work towards reducing these inequities in the future.
OBJECTIVE: To compare early- vs. late-phase gynecologic oncology trials with respect to rates of trial completion and enrollment of racial and ethnic minority groups (REMGs).
METHODS: Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified and compared between early- and late- phase trials. Reporting and publication rates were compared. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics.
RESULTS: Of 223,690 trials identified, 2146 (0.9%) were focused on gynecologic oncology. Most gynecologic oncology trials investigated ovarian cancer (n = 1092, 50.8%), followed by cervical cancer (n = 350, 16.3%), and uterine cancer (n = 334, 15.6%). Only 22.1% (n = 474) of trials either reported results or led to publication. Early-phase trials were more likely to be published than late-phase trials (18.4% vs. 8.6%, p < 0.001). Among US-based trials which published (n = 252), 199 were early-phase (79.0%; phase I, phase I/II, or phase II), and 45 late-phase (17.9%; phase II/III, III or phase IV). 33.7% of early-phase trials (n = 67) reported race/ethnicity data compared to 64.4% of late-phase trials (n = 29, p < 0.0001). Of those trials which reported race/ethnicity, more patients identified as White (85.7%) in late-phase trials as compared to early-phase trials (72.0%, p < 0.001).
CONCLUSION: In clinical trials in gynecologic oncology, early-phase trials were more likely to reach publication than late-phase trials. While late-phase trials were more likely to report race/ethnicity data compared to early-phase trials, early-phase trials were more likely to enroll REMGs. Further research must be conducted to determine reasons for the overall low publication rates of gynecologic oncology trials and relative under-enrollment of REMGs in late-phase trials, in order to work towards reducing these inequities in the future.