“Exciting New World”: Mahnu Davar Shares Insights on Decentralized Clinical Trials in Law360

Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was quoted in Law360, where he discussed the U.S. Food and Drug Administration’s recent guidance on how sponsors of new medical products can conduct decentralized clinical trials. Such trials include telehealth visits, in-home monitoring, and appointments at local health clinics.

Davar said the FDA’s guidance “certainly gives sponsors and investigators more tools” but that there is “still some uncertainty around execution that sponsors are going to have to really focus on.” He noted that trial personnel will have to adjust to carrying out some of their work remotely. “There’s going to be a period where sponsors are going to have to get comfortable with validating the technologies that are going to get used,” he said.

Nonetheless, the guidance provides a “road map” for understanding what the agency would like to see, Davar continued. “There is now a framework in FDA’s mind for how you do these things correctly,” he said.

Davar explained that decentralized trials have the potential to expand the diversity in studied populations, reduce costs that are a barrier to Phase 2 and Phase 3 drug trials, and provide access to information in real time. “This is an exciting new world,” he said. “I think there’s a lot of promise to decentralized trials.”

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