Diversity Action Planning: 5 Myths About the FDA’s Recent Guidance

In June 2024, the U.S. Food & Drug Administration (FDA) officially rolled out its long-awaited updated guidance on creating Diversity Action Plans for clinical trials. Though governmental agencies have been involved in helping advance progress toward more diverse clinical trials for years, this announcement reinforces a more assertive position by the FDA in proactively supporting health equity in clinical research. ‍

To properly understand these new clinical trial FDA recommendations — as well as corresponding misconceptions about creating your diversity action plan — we sat down with our very own Chief Medical Lead Camille Pope, PharmD, RPh.

Myth #1

Recent clinical research recommendations only discuss boosting diversity in recruitment.

There’s no question that the FDA’s recent guidance on creating Diversity Action Plans is rooted in enhancing diversity throughout clinical trials. However, there’s more to the set of recommendations than just diversifying recruitment efforts, such as how to implement more equitable community engagement strategies. 

Dr. Pope reflects on the expansive nature of this rollout:

“If you look at the differences between [the draft guidance in] 2022 and [the updated recommendations in] 2024, the ‘how-to’ section talks about sustained community engagement and diversity of  clinical trial sites — including  cultural competency training for the sites that you do engage or wish to consider for your clinical trials.”

Importantly, these recent diversity action plan recommendations aren’t motivated only by efforts to diversify participant pools. Dr. Pope suggests the FDA understands how robust and thorough strategies for advancing diversity in clinical trials tie directly to safe and effective drugs for more populations. Dr. Pope says:

“It's important for different groups who haven't been included in clinical research in the past to be included. There may be differences in genetics, biology, and metabolism that can make it so that drugs work differently in various groups of people.” 

Myth #2

Your Diversity Action Plan only needs to address race & ethnicity.

The FDA’s 2024 Diversity Action Plan guidance covers a broad range of demographic data beyond race and ethnicity. It includes considerations for age, sex, gender identity, socioeconomic status, geographic location, and other factors that can impact health outcomes and drug efficacy. The goal is to ensure that clinical trials reflect the intersectionality of diverse populations likely to use a medical product — thus providing more comprehensive and relevant information.

According to Dr. Pope:

“That's why this guidance is important. It's a reinforcement of what has been strongly recommended in the past — still highlighting race and ethnicity, but also talking about the other dimensions of diversity that should be considered.” 

Acclinate’s NOWINCLUDED community platform addresses complex intersections with disease-specific awareness and education campaigns and events. Here’s a deeper dive into how NOWINCLUDED mobilized health equity initiatives for maternal care.

Myth #3

Compliance with the recent Diversity Action Plan guidance isn’t a big deal.

While the FDA’s guidance may not be a set of clinical research regulations, it reflects the agency's current thinking and is highly influential in the pharmaceutical industry. Dr. Pope remarks:

“It's guidance. It's a strong recommendation. It strongly recommends that you not only [aim to improve diversity], but also create a Diversity Action Plan that you submit outlining how you'll go about including these historically marginalized races and ethnic groups that you haven't intentionally considered including in the past.”

Still, sponsors who fail to submit a proper diversity action plan may face challenges during the review process, as the clinical trial FDA approval processes emphasize the importance of inclusive clinical trial data to ensure the safety and efficacy of medical products across diverse populations. And falling short can have real-world consequences on everything from how you advertise your medication to post-market processes.

Dr. Pope expands:

“More and more pharmaceutical companies are being asked by the FDA to conduct post-marketing studies because they don't have diverse populations in their initial clinical trials; this requires spending more money. They’ve already spent millions of dollars doing this big pivotal phase-three clinical trial and the FDA says ‘Well, great data. We're going to approve the drug, however you need to do additional trials now in the Black  [or other underrepresented] participants who you didn't include the first time.’” 

Myth #4

Implementing diversity action plans significantly increases the cost and complexity of clinical trials.

While there may be some additional costs associated with outreach and engagement strategies to access diverse populations, the FDA’s guidance aims to balance these efforts with the overall goal of achieving more representative and meaningful clinical trial results. In the long run, including historically marginalized communities can improve the generalizability of study findings and potentially reduce costs associated with aforementioned post-market studies.

Dr. Pope explains:

“If you build in the correct way early on to include historically underrepresented patients in your trials, you may not have to spend budget later proving to the FDA that the drugs are safe and efficacious across a broad range of diverse populations or maybe working backwards.”

Acclinate enables more efficient use of clinical trial resources by providing sponsors with its AI-powered predictive analytics tool, e-DICT.

Myth #5

Diversity Action Plans are only necessary in the final stage of new drug applications.

The guidance encourages sponsors to consider diversity from the early stages of clinical trial design and throughout the development process, not just at the final approval stage.

What’s the best way to ensure that your Diversity Action Plan adheres to these parameters? Dr. Pope proposes that you start implementing community engagement strategies as early as possible. She explains:

“Updated guidance recommends that companies submit their plans to the FDA for review prior to starting a big phase-three or pivotal clinical trial, which is important because it takes time to build affective trust and truly engage in a genuine fashion with people you haven't engaged with before.”

Advance and expand your clinical trial recruitment process

By addressing these misconceptions, our hope at Acclinate is that stakeholders can better understand and implement recent guidance for clinical trials FDA will review, ultimately leading to more inclusive and representative clinical trials. But traditional recruitment processes won’t help you reach compliance. 

At Acclinate, we leverage a model of affective trust to boost inclusivity in trials faster and for the long term. To learn more about how our solution works, schedule a 1:1 meeting with our team.