Ensuring Diversity in Clinical Trial Enrollment: A Mandate for Change
4 Minute Read
Clinical trials—and the sites where these studies are conducted—exist to prove the safety and efficacy of therapies and other medical products. Yet, their results are only helpful if they accurately reflect outcomes in the entire target population. For too long, that has not been the case; historically, clinical trial participants have been neither racially nor ethnically diverse. But that is about to change.
On June 26, the Federal Drug Administration (FDA) issued draft guidance designed to help bolster clinical trial enrollment of participants from under-represented racial and ethnic populations. The guidance outlines steps for diversity action plans (DAPs) that will eventually be mandatory for all clinical studies. While this guidance is still under review, it provides a useful framework for industry, as people consider how to make trials truly inclusive. That framework will be made real through the site locations that serve as the hubs for recruitment and participation in each study.
The Roots of Homogeneity in Trial Populations
As a clinical research site company founded with a focus on diversity, we believe its fundamental import to effective clinical trials is obvious: If a prospective drug, device or medical product is meant to be used on everyone suffering with a certain disease or condition, then its safety and efficacy should be proven in a correspondingly diverse population. Yet, historically, clinical trials have not enjoyed that breadth of inclusion. Among the myriad reasons:
- For sound historic reasons, many minorities have a deep mistrust of the healthcare system, which then leads to recruitment challenges for clinical trials.
- Sponsors often turn to a consistent group of lead investigators and Centers of Excellence to manage their trials; recruiting exclusively from the patient base of those groups inadvertently curtails broader access to trial participation.
- Similarly, if trial sites are difficult to reach via public transportation or require participation during specific hours that overlap the workday, many working people will find it inconvenient or impossible to participate.
- Finally, standardized eligibility criteria used as a template across trials may inadvertently exclude certain populations.
While none of these barriers has been erected to intentionally limit trial participation, the result never-the-less remains: Today, 79% of clinical trial participants are Caucasian—and only 1% are Hispanic, despite the U.S. population being 19% Hispanic.
New FDA Guidance Sets the Industry’s Course
Over the past several decades, the FDA has been evolving guidance to encourage sponsors to broaden their recruitment efforts. In 2022, the Food and Drug Omnibus Reform Act, among other goals, codified the objective of diversifying clinical trials. This latest guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry, is the next step. As the guidance states:
Diversity Action Plans are intended to increase enrollment of participants who are members of historically underrepresented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended use population.
The guidance does not stop at racial and ethnic diversity. The FDA advises sponsors to include a broad representation of all demographic attributes, including sex and age. In separate commentary, the FDA encourages sponsors to also consider geographic location, gender identity, sexual orientation, socioeconomic status (SES), physical and mental disabilities, pregnancy status, lactation status, and co-morbidities when developing a DAP. They conclude that this is most likely to happen if there is a clear plan to ensure both enrollment and retention.
The guidance specifies:
- Sponsors must disaggregate enrollment goals by:
- Race
- Ethnicity
- Sex
- Age group
The FDA offers guidance for reporting within each category, and sponsors should set goals according to that guidance.
- The DAP must detail how the sponsor plans to meet the specified enrollment goals, including descriptions of:
- The enrollment and retention strategies for the study population (focus is on measures that address diversity and representativeness of participants enrolled in a specific clinical study)
- The plan to monitor enrollment goals during the conduct of the clinical study to ensure that goals are met
The full draft guidance is available here.
Rapid Deployment of New Recruitment Strategies
The FDA recognizes that casting a wider net for potential recruits is not an overnight process. They also note that sponsors often assume that the challenges of enrolling a representative population can have a negative impact on study timelines—which is bad for everyone. This is one reason the FDA asks sponsors to develop and implement detailed recruitment and retention strategies for each trial.
Currently the guidance applies to Phase 3 trials for drugs, and to Investigational Device Exemption (IDE) applications for devices. The FDA strongly recommends that sponsors also develop a comprehensive diversity plan across their entire clinical development program. It can be assumed that, with time, this will become mandatory.
The public has 90 days to comment on the draft guidance. But once it is finalized, all companies that begin enrollment 180 days later will be required to submit DAPs. That is a relatively short timeframe to implement new recruitment plans.
Effective Implementation
Sponsors must now focus on creating and managing Diversity Action Plans. This will require them to find new pools of qualified participants without slowing trial start dates, while ensuring participation retention. But how can a sponsor ensure a clear path to both enrollment and retention?
An ideal solution would be to partner with clinical trial sites that already have a robust pool of racially diverse potential program participants in place, with the tools and track record to keep participants engaged throughout the course of the trial. This is the first step in ensuring true parity in healthcare outcomes.
To learn more about how Alliance Clinical can support and deliver on your Diversity Action Plans, contact us.
