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FDA Guidance Directs Researchers On Use Of Patient Advocates

Executive Summary

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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Want Better Clinical Trial Design? Get Early Patient Input, Says FDA

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.

Medtech Companies Need To Do Better At Patient Engagement, Expert Says

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

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.

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