he race is on—at what is called Warp Speed—to drive urgently needed innovation in addressing the worst crisis in public health of our generation. The coronavirus pandemic has also shined a harsh light on the impact of underlying health disparities. The summer of 2020 highlighted a growing body of public health data demonstrating stark disparities in deaths due to COVID-19 in African Americans and Hispanics. The social determinants of health are clearly a factor: high-density urban environments, poverty, jobs that do not allow working from home, and lack of access to PPE (Personal Protective Equipment). But underlying health conditions, co-morbidities of underlying chronic diseases well known as health disparities, have also been identified as major contributing factors.

NIH and FDA policies on demographic inclusion in clinical trials can be summarized thus: Clinical trial inclusion should reflect the population likely to need the therapeutic, including relevant co-morbidities, such that inclusion and exclusion criteria do not inappropriately leave out relevant patients. Trials for new therapeutics ideally are agnostic as to participants’ social class and economic access. However, the recognition that clinical trials lack meaningful demographic inclusion is long-standing and has proven quite difficult to solve despite a range of initiatives ranging from the FDA Demographic Rule, NIH’s policy, a Congressional Mandate in 2012 to study demographic inclusion, increased transparency to raise awareness (the FDA Drug Trials Snapshots), as well as advocacy by health professional organizations (such as the National Medical Association, the National Hispanic Medical Association, the American Medical Association and others) and patient advocates (such as Research America! The Genetic Alliance).