Presentation (CTI)

OBJECTIVES: To report and discuss the practical application of the Clinical trial Diversity Rating (CDR) tool developed by the Institute for Clinical and Economic Review (ICER).
METHODS: This case series examined the pivotal trials included in the eight completed ICER drug assessments since the introduction of the CDR tool as part of the 2023 Value Assessment Framework (VAF) update. The CDR tool evaluates clinical trial diversity quantitatively by comparing clinical trial participants to disease-specific prevalence estimates and using a pre-defined threshold to rate each trial as good, fair, or poor on three demographic characteristics: race/ethnicity, sex, and age (older adults).
RESULTS: The representation of age and sex was rated as good or fair in the majority of trials evaluated, while race/ethnicity tends to be rated as fair or poor. Based on the approach outlined in the VAF, we sought to evaluate only the population of patients recruited in the US on racial and ethnic diversity. However, challenges in implementing the CDR tool include the current trend of global trials without reporting US-specific enrollment information and the lack of reliable US disease-specific prevalence estimates for racial and ethnic groups, particularly for rare diseases. There were also instances where participants in the clinical trial may differ from patients who would ultimately use the drug, and thus, we evaluated representation relative to the disease-specific prevalence estimates for both groups. In this presentation, we will further explore the benefits of the CDR tool to promote conversations around equity in clinical trials of new drugs, expand upon the challenges in implementation, and discuss our solutions.
CONCLUSIONS: The CDR tool offers an objective and transparent method for assessing clinical trial diversity. Support from stakeholders who can provide clearly reported, US-specific clinical trial data and/or reliable prevalence data would enhance the applicability of the tool.