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 intend 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.*
In our own studies, the levels of participation vary. Pfizer published a landmark retrospective analysis in Contemporary Clinical Trials of the ethnic, racial, age and gender diversity of our clinical trials conducted in the US between 2011 and 2020. This study serves as an important industry benchmark and baseline from which to measure our future progress in advancing health equity. Download the highlights from this report.
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 understand that overcoming barriers and challenges to fair representation in clinical trials won’t happen overnight nor can it be achieved by a single company, but we are committed to doing our part. Pfizer is committed to having all of our clinical trials reflect the racial and ethnic demographics of the countries and communities in which we conduct our trials and is taking decisive steps towards meeting this goal, such as:
- Embedding the importance of diversity in clinical trials within our organization;
- Evolving how we partner with clinical trial sites by taking a data-driven approach to choose sites (such as medical centers) in communities that represent a diverse pool of potential participants and help them increase engagement and recruitment;
- Building trust and awareness in communities by engaging with patient advocacy organizations and the media to raise awareness about the importance of trial participation. We are making it easier for patients to find information about potential trials available to them, by providing culturally relevant and linguistically appropriate materials in multiple languages; and,
- Addressing practical barriers to participating in trials, such as reimbursement for transportation to a clinical trial site. We are also embracing digital tools to reduce the burden on volunteers, introduce flexibility in trial design and conduct, and in some cases, eliminate the need to travel.
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