Recent Posts
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 MoreDozens 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.
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.
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