December 28, 2018

Should Patients Engage in the Design of Device Trials? FDA Wants Your Views.

The device group at the Food and Drug Administration is seeking comments on Patient Engagement in Clinical Trials. Not just as trial subjects but as participants in the development of studies.

So far there are no comments. I'm willing to bet that people with diabetes have views on patients being involved in designing the trials for the devices that we use to manage our health. Now is the chance. Particularly as automated insulin delivery devices are poised to revolutionize diabetes care.

What do you think? Should FDA encourage device sponsors to include patients in the early process of defining trials? Where should devise sponsors be looking for patients with who to engage?  -  advocacy groups?

A full discussion of what they are seeking comments on can be found in the DOC or PDF files here. (1) The document runs around nine pages. But here are the reader's digest version of the discussion questions asked in the document.
• Define “patient engagement” in medical device clinical trials.
• Explain the value and positive impact of engaging patients in the design, conduct, and
communication of clinical trials.
• Describe barriers and challenges in engaging patients for clinical trials.
• Outline how and when sponsors can engage patients in the design and conduct of clinical trials.
You don't have to answer all the questions. All feedback is welcome.

Please comment into the docket at this link. (2)

I am a voting member of these Patient Engagement Advisory Committee (PEAC) to which FDA posed these questions in November. FDA has subsequently asked members of PEAC to share this docket. It is open to January 8.

They are listening, so say your 2¢ now!

(1)  Links to documents: download a PDF here:


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