FDA Poised to Make Impact on Underrepresented Populations in Clinical Studies

Diversity Action Plans (DAPs) aim to improve data that the FDA receives by increasing the clinical enrollment of historically underrepresented participants. Increasing diversity in clinical trials not only makes the findings more relevant to various patient groups, but also enhances knowledge about the disease or medical product being studied. This, in turn, provides crucial insights that help ensure the medical product’s safe and effective use among patients.

The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research. This effort seeks to provide the pharmaceutical industry with more accurate representation of patient populations, thereby enhancing the safety and efficacy for prescription drugs and medical devices.

What Does The New FDA Draft Guidelines Include?

The new FDA draft guidelines aim to include even more underrepresented communities in trials, and increase the focus on operational measures to enroll and retain these populations. This crucial inclusion of diverse populations through enrollment accuracy creates a direct correlation to operational efficiency, allowing for a quicker go-to-market process, a reduction in costly mistakes, and a more robust alignment to overall FDA requirements.

A critical aspect of these guidelines is the increased granularity regarding the timing and contents of Diversity Action Plans. This sets the stage for binding and enforceable components per Section 3601 of the Food and Drug Omnibus Reform Act (FDORA), which will come into effect 180 days after the final guidance is published.

This is monumental, as most guidances do not include binding elements per legislation. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements.

“It’s been too long of a wait, but we’re happy that the draft guidance arrived, and we’re grateful to those in office who made this possible,” said Ariel Katz, H1 CEO and co-founder. “Now, we’re at a place where the rubber is going to meet the road with the FDA reviewers, and we’ll see if they’re going to enforce this new guidance. We’re curious to see what will happen over the next 12 months and how pharma companies will respond.”

Through this increased concentration on diversity, enrollment prediction is strengthened. Trials can be more accurately representative of modern population trends instead of clinicians being reliant on leveraging data that is out of sync with current numbers. This allows the trial to achieve more precise results at the indication level through leveraging comprehensive information from across the globe.

The Impact of Draft Guidance on Drug Development

As it stands, drug development is an expensive endeavor, costing approximately $2.3 billion and taking upwards of 15 years. This draft Diversity Action Plan Guidance provides a vehicle to transform drug development in ways akin to what Six Sigma did to improve the pharma supply chain process.

Many believe this to be a step in the right direction over previous guidance as more established structures provide clarity while exposing gaps for future scaling. The goal is to implement strategies that can transform the systems currently in place. In the end, this guidance draft moves toward creating safe and effective drugs for all patients…not just some.

“I am optimistic that society, science, and the belief that ‘medicine for all’ is better than ‘medicine for a few’ will be the way of the future,” Katz continued. “I am thankful that the FDA is taking this step in the right direction for all of us.” H1 is excited to see the FDA push the boundaries of inclusion and diversity with this new draft. Quality insights make a difference and H1 has the data needed to support compliance with FDA requirements and diverse clinical trials. Find out more by requesting a demo today.