Commenters on FDA’s recently opened docket for proposed changes to the PPI Guidance made their recommendations clear: we need more specificity in FDA’s expectations for use of PPI data in regulatory decision-making. Specifically, there is a strong desire for FDA use existing best practice recommendations; the need to increase the expectation and accountability of those conducting PPI studies to engage patients in the study design process; more transparency around how FDA will use PPI data in its decision-making; a desire to see the guidance expanded to therapeutics beyond medical devices; consistency in attribute definition and utilization; and greater clarity around FDA’s expectations for study methodology. The hope is that FDA takes these thoughtful and substantive comments into account when updating the PPI guidance.
Read MoreIt’s been a few years since I wrote in this space. That is about to change. I’m ready to un-circle the wagons and jump back in to the discussion around patient-focused policy. Join me in moving the needle toward effective policy that gets the patient voice into regulatory decision-making.
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Most people expect to be compensated for their time when they provide a service, except when that service is clearly intended to be voluntary. When it comes to engaging patients, there is a persistent question of whether those patients should be compensated for their time. This post explores the issue of whether we can achieve equitable compensation for patients who contribute to observational or clinical research, not as human subjects, but as part of the research team.
Read MorePatient x Design is a concept by which we include patient input throughout the medical product life-cycle. Like Quality by Design, Patient x Design compels medical device sponsors to seek patient input at all points during medical product design, development, clinical testing, regulatory submission, post-market surveillance and beyond.
Read MoreThere are dozens of terms being used in the patient-focused policy space. I try to make sense of some of them, but a cohesive policy framework would help create consistency around how we describe patient-focused data and policy activities.
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