How PRIMR Helps Sponsors Meet FDA Diversity Guidance

By: Aprylle Canono and David Grew MD MPH

“We’ve built PRIMR with unique offerings that directly align with the objectives of the FDA's diversity action plan.”

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In April 2022 the FDA finally issued guidance for clinical trial sponsors on creating diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials.  Many in the industry felt this was long overdue and had been struggling to codify and formalize a diversity plan for some time.  And so while there were many well-intentioned efforts, there was no established standard guidance issued by the FDA. Now there is, and sponsors are building a combination of in-house and outsourced teams to comply with the guidance, optimize their chances of FDA approval, and bring new products to market with maximal societal impact.

In this piece, we’ll do a targeted overview of the FDA’s guidance, review key items to include in a diversity plan, and share insights about how PRIMR is helping sponsors meet the FDA’s guidance.

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Why is diversity in clinical trials important?  The role of the FDA is to make sure new medical products are safe (don’t hurt people) and effective (they actually do what they say they do).  In order to credibly say a new product is safe and effective, the sponsor and the FDA need to test it on humans.  Until now, there was no formal guidance saying the group of humans you test the product on should mirror (in terms of race and ethnicity) the group the sponsor will ultimately market and sell the (eventually approved) product to.  Historically, certain racial and ethnic groups are underrepresented in clinical trials.  With this systematic pattern, we’re approving new drugs and devices that may not in fact be safe and effective in certain racial or ethnic groups.  This public health risk has been apparent for some time and is the driving force behind the new guidance.

When is a Diversity Plan recommended?  Forgive the rather technical answer:  The FDA recommends a Diversity Plan to enroll representative numbers of participants from historically underrepresented racial and ethnic populations be submitted to the investigational new drug (IND) application, for a drug, including biological products regulated as drugs, or the investigational device exemption (IDE) application, for a device.  That said, they also recommended the Plan be discussed with the FDA “as soon as practicable during medical product or development.”  For drugs, this should happen during discussions of a pivotal trial, usually at the end of phase 2 (EOP2) meeting.

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‍Components of the Race and Ethnicity Diversity Plan:

The guidance outlines several key components that must be included in the Race and Ethnicity Diversity Plan. These include:

         Overview of the disease/condition: Describe the context of the medical condition being studied.

         Representation among underrepresented groups: Analyze how the disease affects historically underrepresented populations.

         Evidence of racial/ethnic variation in disease or treatment: Review existing evidence of potential differences.

         Scope of medical product development: Describe the scope of your product's development program.

         Planned trials and their details: Outline study design, eligibility criteria, endpoints, and more.

         Pharmacology study findings: Identify potential effects of the treatment based on race or ethnicity.

         Enrollment goals: Clearly explain goals for underrepresented racial and ethnic participants.

         Plan of action for diversity: Detail strategies for enrolling and retaining diverse participants.

         Diversity metrics and contingency plans: Define metrics and actions if goals are not met.

         Status of meeting enrollment goals: Continuously evaluate and report progress.

While creating a diversity plan might seem straightforward, its successful execution requires thoughtful consideration and collaboration among clinical trial stakeholders.

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Strategies to Increase Racial Diversity in Clinical Trials:

         Rebuilding Trust: Address the historical abuses and exploitation that have eroded trust among certain communities. Engage with trusted community leaders and organizations to build rapport and transparency.

         Inclusion and Exclusion Criteria: Reevaluate trial criteria to ensure unnecessary exclusions are eliminated, opening up participation to a broader range of patients.

         Expansion to Community Sites: Collaborate with local clinics, pharmacies, and health centers to bring trials closer to patients' communities, reducing travel barriers.

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Executing the FDA Guidance for Diversity

The FDA's guidance provides the roadmap, but the journey toward diverse clinical trials requires careful planning and execution. While the guidance specifically targets racial and ethnic diversity, it also emphasizes the importance of inclusion for LGBTQ+, elderly, and disabled patients. The flexibility offered by the FDA in implementing these strategies allows sponsors and clinical research teams to adapt to their unique situations.

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PRIMR's Contributions to Enhancing Diversity in Clinical Trials

In the pursuit of achieving greater diversity and inclusivity in clinical trials as advocated by the FDA's guidance, we’ve built PRIMR with unique offerings that directly align with the objectives of the FDA's diversity action plan. PRIMR plays a significant role in bridging the gap between clinical trial investigators, patients, and the broader community. Here are some of the distinct ways in which PRIMR contributes to advancing the FDA's diversity action plan:

         Multilingual Patient Video Content: PRIMR's provision of educational videos about cancer demonstrates our core commitment to inclusivity. By creating these videos in multiple languages, PRIMR ensures that critical information about clinical trials, cancer research, and cancer treatment options reaches diverse communities that might otherwise face language barriers. This directly aligns with the FDA's goal of increasing participation from underrepresented racial and ethnic populations, making crucial information accessible to a wider range of patients.

         Simplified Explanation of Complex Trials: Clinical trial protocols and procedures can be complex and difficult for patients to comprehend, especially those from non-medical backgrounds. PRIMR's involvement in helping clinical trial Principal Investigators (PIs) simplify and communicate the intricacies of trials is invaluable. By breaking down technical jargon and presenting trial information in a more understandable manner, PRIMR assists in eliminating potential barriers that might deter individuals from diverse backgrounds from participating

         Empowering Patients Through Education: PRIMR's educational videos serve the dual purpose of empowering patients and increasing their confidence to engage with clinical trials. The clarity offered through these resources helps potential participants better understand the trial process, potential risks, benefits, and their rights as participants. This empowerment not only encourages a more diverse patient pool but also fosters informed decision-making among all participants.

         Enhancing Trust and Community Engagement: One of the crucial factors hindering diversity in clinical trials is historical mistrust stemming from past unethical practices. PRIMR's efforts to collaborate with clinical trial stakeholders contribute to rebuilding trust. By creating content that resonates with specific communities and partnering with community-based organizations, PRIMR bridges the gap between clinical researchers and patients, fostering trust and cooperation.

         Promoting Accessibility: Accessibility is a cornerstone of diversity. PRIMR's commitment to offering its educational videos for free on its website enhances access to valuable information for all individuals, regardless of their financial or geographic constraints. This aligns perfectly with the FDA's aim to ensure that diverse populations have equal access to medical research opportunities.

In conclusion, PRIMR's unique contributions play a pivotal role in advancing the FDA's diversity action plan for clinical trials. By providing multilingual patient video content, simplifying complex trial information, empowering patients through education, enhancing trust, and promoting accessibility, PRIMR directly addresses the barriers that have hindered diversity in clinical trials. PRIMR's initiatives foster a more inclusive and informed environment, aligning seamlessly with the FDA's goal of achieving equitable representation and improving healthcare outcomes for all individuals.

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To work with PRIMR on meeting the FDA’s Diversity Guidance, contact us here.

You can read more about the FDA’s Diversity Guidance here: 2020 / 2022.

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References:

US Food & Drug Administration (2023, May 13). Guidance Recap Podcast | Podcast for Patients — Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs. FDA.gov. Retrieved September 25, 2023, from https://www.fda.gov/drugs/guidances-drugs/guidance-recap-podcast-podcast-patients-enhancing-diversity-clinical-trial-populations-eligibility#:~:text=To%20enroll%20participants%20from%20diverse,populations%20receive%20their%20health%20care.

Baumann, J. (2023, January 19). Diversity in Clinical Trials at FDA Gets a Boost From New Law. Bloomberglaw.com. Retrieved September 25, 2023, from https://news.bloomberglaw.com/pharma-and-life-sciences/diversity-in-clinical-trials-at-fda-gets-a-boost-from-new-law

Hobbins, K. (2023, March 6). Public Law 117-328 underscores existing FDA recommendations on improving clinical trial diversity. Mddionline.com. Retrieved September 25, 2023, from https://www.mddionline.com/regulatory-quality/fda-require-diversity-action-plan-clinical-trials

Florence Healthcare (2023, April 17). FDA Guidance for Diversity in Clinical Trials: What You Need to Know. Florencehc.com. Retrieved September 25, 2023, from https://florencehc.com/blog-post/fda-guidance-for-diversity-in-clinical-trials-what-you-need-to-know/

(2022). Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry. Food and Drug Administration. https://www.fda.gov/media/157635/download

(2020). Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. Food and Drug Administration. https://www.fda.gov/media/127712/download

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FAQs:

How does the FDA's guidance address the inclusion of LGBTQ+, elderly, and disabled patients in clinical trials, and what strategies can be implemented to enhance their representation?

While the guidance specifically targets racial and ethnic diversity, it emphasizes the broader importance of inclusivity for these populations. Strategies to enhance their representation may include revisiting trial criteria to eliminate unnecessary exclusions, collaborating with community-based organizations to bring trials closer to patients' communities, and employing accessible communication methods tailored to the specific needs of these populations.

Are there any potential barriers or limitations to implementing the FDA's diversity action plan in clinical trials, and how can these challenges be mitigated effectively?

Yes, these include historical mistrust, logistical challenges in reaching underrepresented populations, and regulatory constraints. To mitigate these challenges effectively, stakeholders may need to engage in comprehensive community outreach efforts, prioritize transparency and communication, adapt trial protocols to accommodate diverse participants, and collaborate with local organizations to address specific needs and concerns.

In what ways does PRIMR collaborate with organizations to rebuild trust and transparency, particularly in communities that have historically experienced exploitation and abuse in medical research?

PRIMR works to bridge the gap between clinical researchers and patients by creating content that resonates with specific communities, partnering with patient advocacy groups, and offering educational resources that empower patients and increase their confidence in engaging with clinical trials.

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