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Abstract:
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Clinical trials in oncology are conducted globally and target large treatment effects in demonstrating efficacy in smaller sized clinical trials. These trials enroll a percentage of the patients in U.S. sites but often fail to have enough patients in each of the demographic subgroups. This talk will present some of the research done in characterizing the disparities in enrollment of patients in clinical trials submitted to the FDA for approval of an indication. Demographic data from past approvals will be pooled for different cancer types and presented by subgroups like age, race, gender and ethnicity. Rates of enrollment in the pooled datasets for different cancer types by demographic subgroups will be compared to the rates reported by Surveillance, Epidemiology, and End Results (SEER) and the U.S. Census bureau. The results of analysis in the multiple myeloma setting will be presented for clinical outcomes in terms of overall survival and objective response rate by demographic subgroups. The talk will conclude with actions taken by the FDA in addressing the disparities in future clinical trials.
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