We know that diversity in our companies and communities brings a wealth of varied experiences and points of view. Did you know that diversity is also essential in clinical trials?
One goal of a clinical trial is to represent the whole population within a disease state. Effectiveness, side effects and even performance of a device may differ across self-reported race, ancestry, genetic variations, or ethnicity. For example, variations in skin pigmentation may impact the performance of a pulse oximeter. Detecting potential differences during clinical development is important, and the FDA requires study results to be presented by factors including gender, race, and age.
Individuals from racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, are frequently underrepresented in biomedical research. These populations can have a higher risk for certain diseases, and it’s critical that they be represented in clinical trials to help ensure that the data generated in the development program accurately reflect the safety and efficacy across the population expected to use the medical product.
The FDA issued a Draft Guidance in April 2022 on ‘Diversity Plans to Improve
Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials’. The FDA recommends that companies create a Race and Ethnicity Diversity Plan as part of the development plan for review and discussion with the FDA. The Diversity Plan should include enrollment goals for underrepresented racial and ethnic populations, strategies to enroll and retain these patients, plans for assessment of data by race and ethnicity and other covariates, and if there is data that supports differences in performance based on race or ethnicity it should include study design features that will support the analysis of populations with different responses.
The FDA advises sponsors to seek diversity in clinical trial enrollment beyond populations defined by race and ethnicity, including other underrepresented populations defined by demographics such as sex, gender identity, age, socioeconomic status, or disability.
What can you do to promote diversity in clinical trials?
- Understand possible barriers to participation in the clinical trial for underrepresented populations, and put measures in place to remove those barriers.
- Barriers could range from lack of awareness of the trial, mistrust of research, time off of work for study visits, or transportation to get to visits.
- Solutions could include partnering with local healthcare providers, patients advocacy groups and community organizations, using study sites that offer flexible site visit times, and providing transportation reimbursement.
- Make patient diversity a part of study site selection criteria, and include sites that serve underrepresented populations.
- Support diversity in patient-facing materials, for example use inclusive language in an informed consent, and provide translations and language assistance if needed
- Partner with a CRO that values and commits to diversity in the workplace and in the clinical trials they support.