Portfolio Leader, Real-World Data Research & Analytics Merative, United States
Background: Recent FDA guidance recommends that trial sponsors include a Race and Ethnicity Diversity Plan to drive toward ensuring that clinical trials reflect the epidemiology of those patients that will use the products. Using real-world data (RWD) trial sponsors can evaluate the impact of inclusion/exclusion criteria including alignment of racial distribution according to disease epidemiology.
Objectives: The goal of this analysis was to compare participation by race in clinical trials for cancer of the cervix to distributions for this disease as reported in two large RWD sources.
Methods: Clinical trials were identified using clinicaltrials.gov and were restricted to U.S. based trials using the search term ‘cervix cancer’. The search was further restricted to trials with results available. Data for the population-based prevalence for cancer of the cervix was obtained from two large U.S databases: the MarketScan Claims-EMR and the MarketScan Multi-State Medicaid databases. Cervical cancer was identified based on presence of at least one non-diagnostic diagnosis code (ICD-10: C53) annually for calendar years 2016-2021. Racial categories were standardized to White (W), African American/Black (AA-B), or Other (O) for both the clinical trials reports and the MarketScan database output.
Results: A total of 29 trials were identified (24 completed, 4 terminated, 1 unknown status) for evaluation. One identified study was not specific to cervical cancer (anal cancer) and was excluded from consideration. Three completed studies and all terminated/unknown status studies were missing information about patient race. AA-B women represented 0% to 16% while W women represented 72%-83% of trial participants (O ranged from 5% to 15%). Pooled distributions by race were 14% AA-B, 73% W and 13% O. Information on race was missing for approximately 10% of women in the database analysis. Among those with non-missing race information 25% of women with a diagnosis of cancer of the cervix were AA-B, 68% were W and 7% were O. Distributions for each individual calendar year were similar with variations of only +/-1-2%.
Conclusions: AA-B women made up 14% of cervical cancer clinical trial participants despite representing approximately 25% of women with a cervical cancer diagnosis in the U.S. While the reasons for underrepresentation in clinical trials are multi-factorial, this analysis reinforces that African American/Black women are underrepresented in trials and highlights how RWD can be used to align population-based representation with trial equity and inclusion strategies.