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Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

 
• By Sue Darcey

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Render illustration of Clinical Trial title on medical documents

At the first meeting of the FDA device center's Patient Engagement Advisory Committee meeting, patients and advocacy groups ticked off a list of perceived barriers to more patient engagement in medtech product clinical trials, including patients lacking knowledge on availability of trials, burdens of getting to the trial site, losing work time, and being kept in the dark about trial outcomes while taking part.

The goal of the first meeting of the PEAC, held Oct. 11-12, was to examine how sponsors and FDA can...

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