What if we had an Attribute Library that helped create consistency across patient preference research? Would it work? While generating consistency and cross-study comparability would be beneficial to the field of patient preference, perhaps we should consider a more flexible repository of attribute knowledge. What attributes would you put in the repository if you could?
Read MoreCommenters 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 MoreFDA recently requested public comment on updates to the PPI Guidance. The most common theme in the comments submitted suggested that all of us want to know what FDA really thinks about PPI studies and how they can support medical device regulatory decisions. If FDA can update the guidance with more transparency, the medical device industry will benefit and so will patients.
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.
Read MoreAttributes are a critical component of patient preference studies. Identifying and defining attributes can be complicated and contentious. But, it doesn’t have to be this way. Those of use who have conducted patient preference studies can show you how to make attribute identification efficient and patient-centered.
Read MoreWhat is patient preference? We have FDA's definition, which describes preference as patients' desire for outcomes or attributes given a choice. But, what does patient preference really mean? And, how can patient preference help medical product sponsors bring their product to market? Preference is much more than making a simple choice between treatments. Patient preference is complex assessment of patients' priorities and desired treatment outcomes. Sponsors can harness these data to support product development, regulatory decisions, commercialization, and more.
Read MoreFDA announced a list of preference-sensitive areas based on input from CDRH review teams. This is a tremendous opportunity for industry to engage with FDA and determine how patient preference data can support a sponsor’s medical device regulatory and clinical strategy.
Read MorePatient preference research is still not well understood, and is often thought of as another form of market research. Here are three reasons why patient preference studies are not market research.
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