Posted by Michael Wonder on 19 Dec 2022
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them to submit clinical trial data disaggregated by sex, age and race/ethnicity if they have already done so as required by existing legislation or regulation in the United States or Europe.
It is standard practice to collect disaggregated subgroup data during drug development (for example, refer to the international standards outlined ICH M4E(R2)).
