Manatt Health Partner Rachel Sher and National Advisor Donna O’Brien were quoted in Bloomberg Law on a new law aimed at improving clinical trial diversity by requiring diversity action plans for trials conducted by the Food and Drug Administration (FDA).
In the article, Sher explained how the law builds upon the FDA’s draft guidance addressing trial diversity but noted that modifications will likely need to be made to the guidance. “Congress was clearly trying to ... codify what FDA had done in the April guidance. But with that, FDA is going to have to go back and flesh out more of what’s in the guidance,” she said. This would likely include when and how the FDA will grant waivers, how sponsors submit changes to their proposed action plans, and how they will meet Congress’ reporting requirements.
O’Brien discussed how clinical trial sponsors should recognize that community sites that offer access to diverse populations need support to build or strengthen their clinical trial infrastructure and embed clinical trials into care delivery and this needs focused attention. “If you want diverse populations, you have to go to the community, and those organizations aren’t set up to be to be research institutions,” O’Brien said. Providers need effective community engagement to reach patients for trials but how can you achieve trial diversity, “if those settings aren’t well-equipped to even offer clinical trials, it’s going to be very challenging to make an impact,” she added.
Bloomberg Law subscribers can read the full article here.