Addressing Diversity In Patient Recruitment For Clinical Research

It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Both the NIH and the Food and Drug Administration have mounted numerous initiatives, including regulatory guidance aimed to enable and fulfill 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 subjects, of whom an estimated 83 percent are white, but also the representation of investigators at many trial sites as well.

This is critical because clinical care and medical product development are not yet currently representative of all patients. This poses a significant problem for the industry. Missing race and ethnicity data in medical assessments can lead to biased estimates of treatment effects due to a lack of exchangeability. People from diverse groups are underrepresented in clinical research. This is a concern because different people may react differently to certain medical products. Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity.

Does real-world data serve as the key to increasing diverse representation in clinical research? Why does technology play a pivotal role in this transformation?