Dozens of papers, workshops, and white papers have been published in the last few years addressing the myriad of challenges and opportunities associated with the use of real-world evidence (RWE) as evidence of medical product safety and effectiveness. This quarter, I will be teaching the first course addressing real-world evidence in biomedical research for Northeastern University's online graduate regulatory affairs program. The wealth of information available on all facets of real-world evidence use is nearly overwhelming. Yet, it remains unclear whether we can effectively harness the volumes of available data in an ethical and effective manner.
Read MorePatients are the experts about their own bodies and their disease. We now have an unprecedented recognition by regulators and industry that patient experience is valuable. I recently read an interesting white paper published by the Harvard Business School that focused on a theoretical model for how the structure of “user communities” provides a unique context within which ideas and knowledge flow to generate innovation in commercial "firms". It occurred to me that this model could be applied to the relationship between patient communities and medical product industry to ensure that patient experience is a necessary component to product development. Though not a perfect fit, I believe this model could provide some guidance for a framework within the medical product industry and patient communities have greater authentic, transparent, and effective exchange of ideas to drive medical innovation.
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After being fired, sharing my situation so publicly made me vulnerable to failure. But it also opened me up to opportunity. When we acknowledge the possibility that there might be more for us out there, we invite opportunity to come knocking. We will always be able to name the ways that we might fail. But we really find our freedom when we discover all the ways we might fly.
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 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 MoreA recent commentary by Peter Pitts of the CIOMS patient engagement working group warrants further discussion. He makes excellent points about the need for meaningful patient data, but highlights the institutional roadblocks and questions that linger about the benefit of patient engagement in medical product development. In reality, the roadblocks are real, and it will take sophisticated change management to overcome existing barriers to make patient engagement a ubiquitous reality in the medical products industry.
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.
Read MoreA colleague recently told me my blogging was like “Carrie Uncorked”. I was thrilled and then started to wonder why I was “corked” in the first place. Here are some thoughts about the realities of fear and anxiety int he work place.
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.
Read MorePlanet formation provides an unlikely metaphor for rigorously assessing the patient experience. When individual patient stories are objectively assembled using scientific methods, they gain weight and the ability to influence decision-makers.
Read MoreModern patient engagement regulatory policy has its origins in the HIV/AIDS advocacy movement. Legislation in 2012 provided FDA with the power to initiate several new patient-focused initiatives. There has never been a better time for the patient voice to be heard by regulatory decision-makers.
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