Let's Undo Underrepresented Diversity in Clinical Trials
Including diverse populations in clinical studies can improve?the development of medicines and vaccines for everyone. The enrollment of the types of people who are likely to use the medical product may provide information on whether a medicine may work on specific groups of patients in different ways.
That’s why it is useful for people from diverse and underrepresented communities to join clinical studies. This helps address healthcare disparities in gender, age, race and ethnicity, and is needed to help identify differences in clinical outcomes.
Ensuring diversity in clinical trials is a matter of equity. We've made a commitment to design clinical trials so that enrollment can reflect the racial and ethnic diversity of the countries where we conduct clinical trials and the epidemiology of the diseases we intent to treat or prevent.
~ Rod MacKenzie,
? ?Chief Development Officer
Historically, some groups have been underrepresented. There are barriers to participation, some higher for people of color?and indigenous people. They include language barriers, distrust of medical researchers and the healthcare system, low levels of awareness and limited access to clinical trials. The mistrust runs deep. Many in the Black community still remember the syphilis study conducted with Black men in Tuskegee, Alabama. The study ended 50 years ago, but the sentiments of betrayal and exploitation felt by many remains to this day.
For example, Black Americans account for roughly 13 percent of the U.S. population but make up only 5 percent of clinical trial participants. Latinx account for roughly 19 percent of the population in the U.S. but make up only 1 percent of clinical trial participants.*
Today, participants’ health and safety are protected by law and by committees such as “institutional review boards.” These ethics committees, also known as “IRBs,” are independent from the people conducting the study. IRBs carefully review plans for research involving people before research can be conducted and at least once a year while research is conducted. An IRB consists of at least five members of varying backgrounds, and should strive for appropriate representation in gender and racial and cultural heritage.
Ensuring diversity in clinical trials is a matter of equity and being represented. Everyone deserves a chance to raise their hand and participate, contribute and benefit themselves and their communities.
We’re committed to designing clinical trials so that enrollment can reflect the racial and ethnic diversity of the countries in which we operate and the epidemiology of the diseases we intend to treat or prevent. By choosing to volunteer, you will represent people like you—in age, gender, race, ethnicity, and from communities like yours.
The choice to participate in a clinical trial is a personal one and should be made in consultation with your doctor and family. A first step is to learn about the process and see if it might be right for you. More information about the clinical trial experience can be found in the resources below. Help yourself, your family, and your communities be represented.
*U.S. Census and U.S. FDA data