Why All Stakeholders Must OWN The Mission: An Executive Summary
Healthcare transformations take time—and the time lag has consequences.


It has been 25 years since Congress passed the NIH Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Since then, both the NIH and the FDA have mounted numerous initiatives, including regulatory guidance aimed at shoring up the law’s intent.


Despite parallel efforts by biopharmaceutical innovators, the demographics of clinical trials today still do not reflect the racial, ethnic or gender diversity of target patient populations around the world. This is true for trial participants, of whom an estimated 83 percent are white. And it’s true for the race/ethnicity/gender representation of investigators at many trial sites as well.


As advanced health systems around the world enter an era of genomic and precision medicine, lack of diversity across the clinical research landscape is an encumbrance. As of 2018, some 78 percent of individuals included in genome-wide association studies were of European descent, while those of African or Hispanic ancestry made up just 2 percent and 1 percent, respectively, according to a report in the journal Cell. The bias in the data harms our understanding of genetic and environmental causes of disease and impedes both individualized and population-wide efforts in prevention and treatment.


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