The lack of demographic representation in clinical trials is long felt and a well-known challenge for the research community. In the United States, for example, many communities of patients are underrepresented. Whether these communities are defined by gender, race, ethnicity, or socioeconomic status, it is clear that their access to
clinical trials is insufficient.
Spurred on by the COVID-19 pandemic and the resulting need for a quickly produced, safe vaccine that would be effective for all people, the U.S. Food and Drug Administration (FDA) provided new guidance for industry around increasing the diversity of clinical trial populations and made clear that representation will an important factor in therapy approvals moving forward.