Patient getting vaccine; FDA diversity guidance concept

Updated FDA Race and Diversity Guidance Open for Comments

In January 2024, the U.S. Food and Drug Administration (FDA) released its draft guidance on the collection of race and ethnicity data in clinical trials of FDA-regulated medical products. The agency requested that written comments be submitted within 90 days of the release of the draft guidance. The FDA plans to consider comments and publish a finalized version of the guidance later in 2024.

The guidance builds on the FDA’s previous work on diversity in clinical trial populations. It includes several notable points and indicates a path forward for regulatory approaches to improving diversity, equity, and inclusion in clinical trials. 

Items to Note in the FDA’s Draft Guidance

The draft guidance encourages clinical trial teams to build patient cohorts that represent an array of applicable ages, genders, and racial and ethnic groups. The FDA recognizes that not all clinical trial cohorts will meet this standard, however. If a clinical trial cohort is not sufficiently representative of the U.S. population as a whole, “the agency may request or require post market data collection to gather the relevant safety and efficacy data,” write Bethany Hills, Kirsten Axelsen, and Adam Donat at the law firm DLA Piper.

Because this extra data requires time and resources to collect, it can delay the process of bringing a new treatment to market. Meeting the FDA’s expectations while creating clinical trial patient pools can help reduce the risk of facing post-trial data collection requirements. 

Finally, the FDA’s guidance seeks to close the gap in available race and ethnicity data in healthcare. A 2022 study of the national COVID cohort collaborative data enclave, for example, found that “accurate, comprehensive race and ethnicity data” was lacking in the dataset, write Lily Cook and fellow authors.

Healthcare providers in an office setting; FDA diversity guidance concept 

From Draft to Final Guidance: The Path Ahead

Several challenges confront clinical trial teams that seek to perform research based solely on commonly-used data sets. Data sources like commercial health insurance claims, academic tertiary care center data, and geographically-limited healthcare networks, for example, often fail to provide a representative sample of the U.S. population, writes Brian L. Strom.

The FDA’s work on its race and diversity guidance is ongoing. Clinical trial teams can take steps now to embrace the agency’s eventual final rule, however, write Elizabeth S. Russell and fellow authors in the Journal of Clinical and Translational Science. Russell et al. recommend the following steps: 

  • Leverage robust methods and analyses of data, and apply them to real-world data sources.
  • Foster partnerships among stakeholders to guide a cohesive approach to diversity planning. 
  • Use the diversity plan as a guide to expand efforts beyond race and ethnicity.

Several currently used tools can help clinical trial teams reach a broader spectrum of potential clinical trial participants. For example, decentralized clinical trials continue to offer flexibility that can promote a more diverse patient cohort. 

“Decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility,” says FDA Commissioner Robert M. Califf.  

Digital tools like TA Scan can help clinical trial teams meet their diversity goals. TA Scan’s included global ethnicity and demographic data and analytics allow clinical trial teams to develop and implement diversity strategies in line with FDA guidance and best practices. 

By using robust methods and analyses, integrating seamlessly with relevant stakeholders, and planning for diversity from the start, clinical trial teams can maximize the benefit of the FDA’s final guidance on race and diversity in clinical trials. 

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Co-authored by Elke Ydens, Associate Director of Business Solutions, Data Division

Elke Ydens, Associate Director of Business Solutions at Anju’s Data Division, brings over a decade of life sciences experience and a PhD in Biochemistry and Biotechnology from the University of Antwerp. As a Subject Matter Expert in Data Science, she adeptly addresses customer needs, leveraging her background in neuro-immunology and biochemistry. Elke remains dedicated to professional growth, contributing to industry publications, and staying updated on industry trends, while also finding success in extracurricular pursuits, formerly competing in world and European bridge championships, and more recently active in beekeeping and coaching. Connect with Elke on LinkedIn to explore her achievements further.

Co-authored by Paul Sahargun, Senior Vice President of Sales, eClinical Division

Paul Sahargun is a champion for diversity and continues to elevate Anju Software through cultural enrichment and organizational execution. A Certified Life Coach, Paul’s belief in community extends beyond Anju. With 25 years in software that’s highlighted with high-performing sales teams, Paul has forged truly strategic relationships with dozens of leading software companies. Paul is a major advocate for change and believes in both people and business development results. Connect with Paul on LinkedIn to explore his expertise further.

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