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What you need to know about the FDA guidance for diversity in clinical trials.

When individuals elect to participate in a clinical trial, they represent people like themselves and their local communities in ethnicity, gender, and more. Participation in clinical trials by people of all backgrounds can make a difference by reducing health disparities among underrepresented populations and improving the development of medicines and vaccines for everyone.

When trials fail to enroll a diverse study population, they fail to reveal a thorough understanding of how the drug will work in practice. After all, medical treatments impact people differently according to a variety of factors, including their age, race, gender, weight, and lifestyle. Researchers also potentially lose the opportunity to improve access to breakthrough therapies and provide better healthcare to historically underserved communities.

In April 2022, the FDA released a draft guidance for diversity standards that took the clinical research world by storm. While diversity, equity, and inclusion have been major focuses for clinical research teams for a long time, sites and sponsors are now receiving clear plans to improve enrollment of individuals from underrepresented backgrounds.

What’s the goal of the FDA guidance for diversity?

The FDA guidance focuses on racial and ethnic inclusions, especially that of underrepresented populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other people of color. However, this guidance doesn’t cover all forms of diversity. Clinical trial sites and sponsors should also consider the inclusion for LGBTQ+, elderly, and disabled patients.

People of different ethnic and environmental backgrounds may respond differently to certain drugs. The FDA’s guidance has been put in place to ensure clinical trials are evaluating these medications to ensure they’re safe for anyone who may use them. The result? Asking clinical trial sites and sponsors to create a Race and Ethnicity Diversity Plan.

What’s a Race and Ethnicity Diversity Plan?

Site and sponsors must submit a plan on how they intend to enroll participants from underrepresented racial and ethnic backgrounds. These guidelines encourage them to stop and create a plan of action on how to improve diversity, equity, and inclusion for clinical trial recruitment. Sites and sponsors now know they need to:

  • Explain their specific diversity goals
  • Justify why they chose these goals based on the disease they’re treating
  • Describe how they plan to reach these goals

What’s next?

Sites, and sponsors obviously all want to increase the diversity of their clinical trials. They realize that greater inclusion leads to more accurate trial results and better treatments for all patients who need them. That’s why so many clinical trial teams eagerly welcomed the FDA’s guidance on clinical trial diversity.

However, the FDA still gives sites and sponsors a great deal of freedom in determining what methods will help them reach their diversity goals – and that freedom can be overwhelming. But technology, trust-building with community leaders, and reaching out to neighborhood sites all play essential roles in increasing access, diversity, and inclusion.

This year will be an exciting one for clinical research. The industry is in a good position to rise to the challenges that 2023 may pose with innovative ideas and solutions through continued collaboration. The ever-increasing diversity marks a new era for the industry, one with patients at the core.

Looking to chat about the impact of the FDA guidance for diversity in clinical trials? Let’s connect.