P113: Determining the Proper Target Ranges for Race and Ethnicity Representation in Clinical Trials
Senior Director, Scientific Services
IQVIA United States
To demonstrate a process that evaluates multiple RWD sources from which diversity targets for clinical trials can be generated to improve representation of US subpopulations, specifically race and ethnicity (R/E), in specific disease areas.
• Define the indication in terms of ICD10 diagnosis codes
• Query a combination of EMRs, CDC NHIS Survey, scientific literature
• “triangulate” the results, by taking into account the biases of each data set and setting an appropriate range of prevalence for each race and ethnic group
The queries from these different RWD sources sometimes provided vastly different results. Consequently, each source was evaluated based on population representativeness, sample size, recency, sensitivity/ability to identify the disease/condition, granularity of race categories, completeness of data collected, inherent biases, etc., and derive a range based on the most relevant data sources for that particular indication
RWD can be leveraged to support or develop clinical trial diversity goals. Decision-making relies on both quantitative and qualitative considerations to evaluate potential R/E diversity (Figure 1). Estimates in the scientific literature are also important to establish background and contextualization of R/E estimates through a synthesis of multiple studies or cohorts. Future investigations will demonstrate several indication-specific examples evaluating diversity within each data source so that distributions can inform clinical trial planning.
Co-Authors: Monica Goins, Emily Bratton, Eric Gemmen, Robert Stolper - IQVIA