Exceeding the FDA’s Standard for Diversity Action Plans

With the average cost of bringing a new drug or therapy to market exceeding a billion dollars, diversity in clinical trials is as much a business imperative as it is a regulatory and public health one. Studies that fail to represent the growing diversity of patient populations risk not only compromising the strength and generalizability of clinical data, potentially preventing life-saving therapies from reaching patients who need it most, but can also result in costly delays in the approval process.

Earlier this year, the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance for clinical trial sponsors (pharmaceutical and medical device companies) on Diversity Action Plans (DAPs), which are intended to help increase the enrollment of historically underrepresented groups in these trials. Under the 2022 Food and Drug Omnibus Reform Act, sponsors of phase 3 or other pivotal clinical studies are required to submit DAPs alongside study protocols. While the draft guidance focuses on diversity in terms of race/ethnicity, sex, and age group, the FDA encourages sponsors to think broadly about the many factors that could influence trial outcomes, from socioeconomic background or geographic location to disability status or other health conditions.

This new approach reflects the agency’s recognition that traditional recruitment methods are insufficient and invites the biopharmaceutical industry to rethink community engagement to build more representative, impactful trials. According to the FDA, DAPs will “serve as the primary basis for [the agency’s] evaluation of safety and effectiveness and benefit-risk determination” once compliance sets in. In other words, these plans will be a critical component of how new pharmacological therapies and medical devices are evaluated once compliance sets in. (Compliance will be mandatory for trials that begin enrollment 180 days after the publication of the final guidance, which has not been released yet.)

Overview of FDA’s Draft Guidelines

The FDA’s Diversity Action Plans draft guidance provides sponsors with a framework to make trials more inclusive. Below we discuss the key components of an effective DAP as well as how Ichor can help lay a foundation for success.

1. Setting Enrollment Goals
   Sponsors will be required to outline concrete, data-informed enrollment goals, disaggregated by race/ethnicity, gender, and age group, that are tailored to clinically relevant subdivisions of each group (e.g., Asian, Black/African American, etc.). This includes understanding and consideration of the prevalence and incidence of a particular disease on certain populations as well as documented disparities in care and treatment.
   
   
2. Rationalizing Goals
   Sponsors must also describe the rationale for enrollment goals. This includes providing background information about the disease or condition the drug or device aims to treat, such as the natural history of the disease, risk factors, and prevalence. In other words, combining quantitative and qualitative data to support goals that meaningfully address disparate conditions and barriers across communities.
   
   
3. Meeting Goals
   Finally, sponsors are required to outline an actionable plan focused on recruitment and retention strategies that will enable them to accomplish their goals. Such strategies may include, but are not limited to, proactively engaging certain stakeholders (e.g., patient advocacy groups, healthcare workers), providing cultural competency and awareness training for investigative staff, or addressing common barriers for underrepresented groups like childcare or transportation.

How Ichor Can Help 

Ichor’s data analytics and community-based expertise well positions us to help sponsors deploy impactful diversity action plans. Our approach combines rigorous research with hyperlocal community insights to advance clients’ goals while addressing the often-overlooked pain points of underrepresented groups.

Ichor’s health equity experts will work with clinical trial teams to develop and execute robust diversity action plans that are tailored to the specific barriers faced by certain groups. And with an on-the-ground presence in more than 70 U.S. cities, we can engage our strong network of community based-organizations and partners to help identify and overcome barriers to access, improve health literacy, and foster long-term trust within diverse communities.

Contact Ichor to learn how we can position your clinical trial for success and ensure it reflects the growing diversity of patient populations across the country.