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

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 the research after having been informed of all aspects of...