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FDA Advisory Committee Focuses On Improving Informed Consent For Patients Volunteering For Device Trials

 
• By Brian Bossetta

The US FDA’s Patient Engagement Advisory Committee met Wednesday to discuss ways the agency can empower patients thinking about whether to participate in clinical trials of regulated medical products. Central to the committee’s discussion was not only the type of information patients need to evaluate when considering joining a study, but how that information should be presented to them.

Before signing up to participate in a clinical trial and giving informed consent, a patient must consider a range of factors, including potential adverse events, and the more information that patient has — and the easier that information is to digest — the odds of a better patient experience and more successful trial increase.

The FDA defines informed consent as “the process by which a volunteer confirms his or her willingness to participate in...

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