Relevance of Race and Ethnicity Data in Clinical Trials
Data analysis of drug approvals has demonstrated that certain drugs (almost 1/5th) have different responses based on race and ethnicity. Collecting data on a diverse population is critical for identifying race/ethnicity specific signals and responses that would help to adjust the dosing needs. Collection of such data also provides an opportunity to underprivileged communities who could not afford the advanced treatment options available otherwise. Regulatory authorities therefore have recently begun to emphasize that sponsors include a diverse population based on race, gender and ethnicity in clinical trials. In order to achieve this, there are many options available to maximize the inclusion of a diverse population working closely with Key Opinion Leaders, Prime institutions in the US with access to community hospitals as satellite sites. Additionally, leveraging the help of recruitment vendors who utilize AI tools to provide locations in specific regions that could give access to such patient populations.