Modus Outcomes’ CEO, Patrick Marquis, MD MBA, participated in two invitation-only workshops that convened regulatory, academic and industry experts to discuss the interpretation of meaningful within-patient change and personalized COAs – both increasing important elements in the quest to gather robust and meaningful patient and caregiver input to inform medical product development and regulatory decision-making. The two workshops explored both traditional and new technical approaches to meaningful within-patient change and personalized COAs.
Patrick presented Modus Outcomes’ approach to these questions. Our approach moves toward providing a holistic answer that addresses fundamental conceptual and measurement issues, addressing current uncertainty about the best ways to interpret or personalize COAs. This new way of interpreting change moves from existing “black box” approaches to a more transparent model, making clear the connections between the concept measures, the ruler, and the experience of patients. To learn more please contact Andrea Murison (firstname.lastname@example.org).
A link to the workshops can be found here: https://healthpolicy.duke.edu/events/developing-personalized-clinical-outcome-assessments