To find safe and effective treatments for all people, it is critical to include a diverse representation in clinical trials. Historically, clinical trials had poor representation of females and Black, Indigenous, and People of Color (BIPOC), and in some cases excluded them. Gender, race, and ethnicity can each impact how people are affected by disease and how they respond to treatment.
Listen to Community Needs. First, start by better understanding the community and listening to the needs. Don’t start with assumptions, instead listen, and learn.
Underrepresented Groups are willing to participate in clinical research. Many have reasoned that BIPOC are less likely to participate in clinical trials due to a lack of trust in the scientific community. Past abuses such as the well-known US Public Health study of syphilis in Tuskegee, Alabama have understandably cast doubt on the clinical research process. Today, there are protections in place to make sure that all clinical trial participants are treated ethically. While there may be some lingering uncertainty about clinical research, recent studies have shown that underrepresented community members are in fact willing to participate if they are given the information and access they need in order to take part.
To ensure diversity in clinical trials, it is key for researchers to improve communication, build greater awareness and find effective ways to ease the burden on clinical trial participants.
NIH and FDA are setting standards. There are important efforts already being made to increase diversity in clinical trials. The National Institutes of Health (NIH) has made it a requirement that its sponsored studies include females and BIPOC. The Food and Drug Administration (FDA) has issued regulations and guidance to ensure that other study sponsors do the same. Study sponsors are voluntarily providing data to help the FDA track the participation rates of females, males, children, the elderly, and different underrepresented groups. In the United Kingdom the NHS launched the Race and Health Observatory to investigate and address the continuing problem of race inequality in medicine. The research community and the public have become more and more aware of the need for diverse populations in clinical research. It is important that sponsors seek to understand possible barriers to participation and find ways to address them. Industry-wide initiatives, such as PhRMA’s Equity Initiative in the U.S., are helping clinical trial sponsors address barriers and improve participation in clinical research.
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