How to Develop and Execute a Race and Ethnicity Diversity Plan to Increase Diversity in Clinical Trials

On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants from underrepresented racial and ethnic populations, specifically Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color.

Diversity in clinical research is a hot topic, but its trending nature is rooted in real need. As the FDA’s guidance points out, racial and ethnic minorities have long been underrepresented in clinical trials despite having an unequal burden for some diseases. Clinical trials are also used to determine if a drug or device is safe and effective. As different people have different responses to therapies, a trial might lead to an ineffective or unsafe product if it isn’t representative of the intended use population.

To solve these crucial problems stemming from lack of research diversity, the FDA’s guidance provides specific recommendations on creating and implementing a Race and Ethnicity Plan, the FDA’s name for a sponsor’s strategy for identifying and enrolling more diverse patients in their clinical trials.

How the New Guidance Will Impact Your Clinical Trials

As per the FDA’s new draft guidance, sponsors must create a Race and Ethnicity Diversity Plan to “enroll representative numbers of participants from historically underrepresented racial and ethnic populations” and include the plan in any investigational new drug (IND) application for a drug, including biological products regulated as drugs, or in any investigational device exemption (IDE) application for a device.

The plan must meet five requirements. First, it must define a study’s enrollment goals for underrepresented racial and ethnic participants, and these enrollment goals should be based, at least in part, on the trial’s protocol objectives. The plan must also outline a strategy to assess race and ethnicity’s potential to impact the product’s safety and efficacy, and demonstrate study design features that will support analysis of the product for relevant populations when data indicates it might perform differently for various patients based on factors associated with race or ethnicity. Fourth, the Race and Ethnicity Diversity Plan must detail data collection tactics to investigate the possibility of safety and/or efficacy differences in various populations beyond the product’s pivotal studies. Finally, the guidance also specifies that the plan needs to be presented to the FDA “as soon as practicable during medical product development.”

How Will You Meet the Standards Outlined in the Guidance?

Sponsors certainly agree on the guidance’s importance and necessity, but they also agree on the challenges the guidance presents, such as the specific steps involved in increasing diversity in clinical trial enrollment. In other words, if a sponsor is going to write up a plan for enrolling more diverse patients into their trials, they need to know how to find and enroll diverse patients. Elligo Health Research® is here to help.

Only Elligo Identifies and Engages Diverse Patients

Our direct access to known patients with their trusted physicians and research practice management solutions make enrolling diverse patient populations simple.

Our PatientSelect identification and engagement model uses the largest known patient network to provide direct access to diverse, known patients through HIPAA-compliant identified electronic health record (EHR) data so sponsors can match them with the appropriate clinical trial. The PatientSelect model also uses the trusted patient-physician relationship to not only identify diverse patients, but to also engage with them so they’re more likely to enroll in studies.

We also increase diversity in clinical trials by expanding and supporting community-based research with unique research practice management solutions. We mindfully connect with sites in traditionally underrepresented areas to build a site network with access to diverse patients and, at the site selection stage of a study, use unique research agreements and supportive platforms to characterize patient populations and ensure availability of capable sites in diverse areas. Finally, we’re constantly striving to reduce the lack of trust diverse populations have in research by maintaining the established physician-patient relationship and engaging with advocacy and support groups.

Though the new FDA guidance focuses on racial and ethnic demographics, sponsors should also try to increase research diversity in demographics like sex, gender identity, age, socioeconomic status, disability, and more. Elligo’s access to known patients and research practice management solutions enable participation for everyone – including those in underrepresented groups beyond racial and ethnic minorities.

Create and Implement Your Race and Diversity Plan With Elligo

The new FDA guidance adds a lot of work to your already full plate. Let Elligo’s experience make creating and implementing your Race and Diversity Plan achievable and uncomplicated.

Only Elligo gives you access to known patients and our exclusive community-based research solutions so you can quickly enroll diverse patients, accelerate your study, and deliver faster treatments for those who need them, all while enabling greater access to research for traditionally underrepresented populations.

Contact us today to learn more about our diversity-enabling solutions.