FDA Clinical Trial Diversity Guidance Requires New Action Plan

Improving diversity in clinical trials is a hot topic right now with the US Food and Drug Administration (FDA) taking its guidance a step further with the requirement of diversity action plans.

The diversity omnibus spending bill was passed at the end of last year, mandating the creation of diversity action plans that the FDA can use to evaluate the safety and efficacy of drugs and devices.

The move came on the back of the release of draft guidance by the FDA in April 2022, which centered on improving the recruitment of underrepresented groups in clinical research trials. Despite these groups being disproportionately affected by certain diseases, their representation in trials has been inadequate.

This latest requirement to formulate a plan to reach a broader population upfront aims to improve efficiency, rather than postponing diversity considerations – which prolongs an already expensive and time-consuming trial process.

Advancing Medicine for All

The diversity gap is a topic that has been widely discussed in the industry, but progress has so far been slow. The law, which incorporates the DEPICT Act, finally addresses decades of testing drugs and devices primarily on white men, resulting in knowledge gaps on how treatments work on a large proportion of the population.

For example, study enrollment of Black Americans in trials for multiple myeloma – a cancer in which this population represents 22% of yearly cases – was reported as low as 4.5%. And Black people are more likely than white people to develop Alzheimer’s Disease, but an academic review of pre-pandemic dementia research showed that just 4% of trial participants that reported race and ethnicity were Hispanic or Black.

The FDA also has highlighted other contributory factors impacting the enrollment of underrepresented populations in trials, including impractical trial design and constraints related to time and resources. Language and cultural differences, limited health literacy, mistrust, religious beliefs, restricted access and insufficient awareness, also contribute to the challenges to greater trial diversity.

An Opportunity for Sponsors

The FDA guidance offers an opportunity for sponsors to design trials with greater understanding of their relevance and application. For example, clinical research processes could incorporate diversity plans as standard operating procedure and incentivize research that includes a diversity action plan. Institutions could address clinical trial diversity internally, with staff from clinical operations, ethics and compliance.

When it comes to sites, they will need to be supported to achieve the necessary enrollment targets. Finding research volunteers is already a challenge, so it is important to choose sites that “speak the right language” and can optimize enrollment by working closely with the community.

Mandating diversity action plan requirements for clinical trials is a positive step towards ensuring that medical treatments and interventions are effective for all individuals. By requiring clinical trials to include diverse populations, the FDA is promoting more comprehensive and representative data, leading to better treatment outcomes and improved health equity.