Valid / Stratified Analyses

For decades, NIH has required so called valid analysis, also known as stratified analysis, to explore how well interventions work across sex/gender and race/ethnicity for all applicable clinical trials. Last year, we amended this existing policy to require the findings from such stratified analyses on these variables be reported on ClinicalTrials.gov after an applicable NIH-Defined Phase III clinical trial has completed. Ms. Dawn Corbit, NIH's Inclusion Policy Officer, joins us on this podcast to discuss the revised policy and what it means for the extramural research community. By taking this step, we are encouraging findings from stratified analyses to be more readily available to the public as a means to better understand the effect that sex and race may have on health outcomes and physiologic conditions.