e23329 Background: Metastatic prostate carcinoma is a leading cause of cancer related deaths among men in the United States (U.S.). Incidence and mortality are highest among Black men in the U.S. and globally (Lillard Jr et al., 2022). Significant advances in treatment for metastatic disease have been accomplished in the past decade, with multiple publications and data showing increased survival rates for men (Kyriakopoulos et al., 2018). Despite these advances, mortality disparities persist, raising concerns for the generalizability of the clinical trial evidence supporting these therapies. Methods: To understand the impact of this disparity, publications associated with disease treatment approval by the U.S. Food and Drug Administration (FDA) from the last 10 years were reviewed. FDA.gov was utilized to identify that 19 drug approvals were indicated as evidentiary for the FDA’s approval. These studies were reviewed for their racial and ethnic representation relative to disease epidemiology. Trial representativeness was assessed using the DRIVE score, a validated framework measuring demographic alignment between clinical trial populations and affected patient populations in order to determine if they have transportability and generalizability for all patients in the U.S. with metastatic prostatic carcinoma. A DRIVE Score of ≥ 3 is the threshold for clinical excellence (Birhiray & Birhiray, 2023). Results: Of the 19 clinical trials of the approved drugs reviewed, 3 met the minimum DRIVE criteria for clinical excellence, 9 received 1, 2 received 0, 4 received 0*, and one approval was ineligible to be scored due to not taking place in the U.S.. Black men were consistently underrepresented relative to disease prevalence across the majority of trials. Conclusions: The majority of the clinical trials reviewed were not generalizable or transportable to minority populations. Current guidelines published by the American Society of Clinical Oncology do not acknowledge the existing disparities in clinical trials, potentially contributing to therapeutic misappropriation. Regulatory agencies, sponsors and professional societies share responsibility for ensuring that trial data reflects the populations affected by the disease. Using the DRIVE score informs clinicians of existing disparities, and empowers them to choose agents based on their clinical relevance to the populations they serve. Therapeutic misappropriations are common in the treatment of metastatic prostatic carcinoma, as advances in treatment do not apply to minority populations, and a lack of transparency with clinicians about this information leads to further disparities in its treatment.
Ranger et al. (Thu,) studied this question.