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New law boosts diversity in clinical trials at FDA

Posted on the 24th March 2023

Clinical Trials Diversity

Drug and device companies are being urged to prepare for new legal requirements aimed at improving clinical trial diversity.

The 2023 omnibus spending bill was enacted last month (Public Law 117-328) and requires diversity action plans for clinical trials used by the Food and Drug Administration to decide whether drugs are safe and effective.

The legislation aims to encourage investigators to develop a strategy for reaching a broad study population on the front end, instead of either failing to do so altogether, or acting later and increasing an already lengthy and costly clinical trial process.

The law marks an important step in addressing decades of testing drugs primarily on white men that have left a large knowledge gap on the impact and effects of medical products on a large section of the population.

A 2020 study revealed that, despite accounting for 13 per cent of the US population, the median enrollment for the demographic was about 4.5 per cent.

While it is hoped the changes will improve representation, they do allow for exemptions to the diversity plan requirement if trial sponsors can justify a waiver. Starting in 2024, the FDA will have to publish annually an aggregate report of these action plans, along with the reasons any trials fell short of those goals.

There are some differences between the law and draft guidance that the agency will need to iron out.

Those details include when and how the FDA will grant waivers, how sponsors submit modifications to the action plan, and how they’ll meet the reporting requirements laid out by Congress.

FDA’s recommendations focused on race and ethnicity, but Congress also requires demographic information such as age, sex, geographic location, and socioeconomic status.

Meanwhile, finding enough research volunteers is already a challenge. More than 80 per cent of clinical trials fail to enrol enough patients on time.

Related: Health inequalities lead to early death in persons with disabilities

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