Diversity in clinical studies: Why it matters
People from different ethnic backgrounds may have a different response to certain medical products (medicines and medical devices) and that is why it is important for clinical studies to include people from all background and across different age groups, races and ethnicities.
Having diverse representation of people in clinical studies provides a more complete picture of a product’s efficacy and potential side effects. It provides deeper clinical insights about the effects the product may have on a disease or health condition. Some studies need healthy volunteers; others need people who are living with a specific disease or health condition; all need diverse participants.
Diversity in clinical studies is key to advancing health equity.
Unfortunately, some groups have not been as well represented in clinical studies as they should be. One barrier to diversity in studies is mistrust. We all need to work hard to overcome the lack of trust and other barriers. Let’s start by dispelling a few myths.
Myth: People who take part in clinical studies are treated as guinea pigs.
Truth: We are committed to the safety of every person who joins a study. A healthcare team provides expert care and health monitoring for each person in a study.
Myth: Studies are not safe because they use medicines that have not been tested before.
Truth: Before any new medicine is given to humans, it goes through a thorough and complete testing, screening and regulatory review to make sure there is maximum possible safety. A medicine is only tested in humans if the results of these initial studies are promising.
Myth: People who take part in a study are not informed during the study.
Truth:The first step in joining a study is called informed consent. As part of this, the study team will explain the study and answer any questions. People who take part in studies are treated with respect and dignity and must consent to participate in a study; they can withdraw their consent at any time, for any reason. You can learn more about informed consent on the FDA’s website.
For additional information about clinical studies and diversity, download this helpful brochure: