Why Diversity Matters

Why is diversity important in clinical trials?

Clinical trials help researchers decide if new treatments are safe and if they work. Different people can have different reactions to a treatment. This might be because of their age, sex, weight, race, ethnicity, or other factors. Through clinical trials, researchers may find differences that help the treatment work for different groups. They may find that some people need a different dose or need to take the treatment at different times. Or they may even find that the study treatment does not work for some groups at all.  

Clinical trials also provide early access to experimental treatments for a range of diseases. Prioritizing diversity within studies will help ensure people of color are not left out of these potentially lifesaving opportunities and move us closer to a more equitable healthcare system.

There are historical cases where people of color were mistreated in clinical trials... How can I be assured things are different now?

Today, all patients and research participants -- including people of color -- are kept safe by law and ethics committees, including Institutional Review Boards (IRB), that oversee clinical trials. Every clinical trial at every facility, by federal authority, must be approved and monitored by an IRB. IRBs include doctors, nurses, scientists, and community advocates who make sure that each clinical trial is ethical, does not have unnecessary risks, and that patients' rights are protected.

Once approved by the IRB, the study's organizers must follow a careful and detailed plan, called a protocol, that spells out exactly what will happen during the clinical trial. Patients will know the full details of the protocol prior to joining.

Informed consent laws are used for this purpose as well. They require clinical trial researchers to provide complete, up-front information, including all of the study's benefits and risks for participants.

The U.S. Food and Drug Administration (FDA) also plays a primary role by reviewing clinical research and upholding ethical and legal protections as part of the final public approval process. The agency continues to work with federal partners, manufacturers, medical professionals, and health advocates to ensure that all participants are properly treated, and all data is collected appropriately in clinical trials.