FDA Guidance Directs Researchers On Use Of Patient Advocates
A new guidance document from the US agency offers advice on how sponsors can use patient advocates to improve and streamline device clinical trials.
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A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.
A top clinical research expert says the medical device industry is lagging behind the pharmaceutical industry when it comes to engaging patients. While industry groups are pushing for more patient preference be factored in in regulatory decisions, John Lewis of patient advocacy group Heart Valve Voice says medtech companies themselves are not investing enough in this area.
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.