Patient Engagement at a Tipping Point--The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, "Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products"

This article discusses insights gleaned from the DIA conference, "Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products" (September 2015). It highlights the changes that will need to occur within the patient, medical-product sponsor, and regulatory cultures in order for patient engagement to become integrated into the medical-product development process and life cycle maintenance. Furthermore, it emphasizes that reaching the desired future state will require a conscious commitment from all stakeholders to work collaboratively to develop shared solutions and to map a common path forward.

Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Smith, M. Y., Hammad, T. A., Metcalf, M., Levitan, B., Noel, R., Wolka, A. M., Michaels, D. L., Johnson, F. R. Tags: Policy Source Type: research