The Ohio State UniversityCollege of Pharmacy, United States
Clinical trial designs intended to support product approvals have evolved due to many factors including consideration of the patient perspective. The 21st Century Cures Act described patient-centered initiatives and modified standards of evidence that will likely be part of future approval and promotional landscapes. As illustrated with recent approvals in gene therapy and basket-trial design, there are unique considerations for the patient experience, providing opportunities to evolve promotional practices. This session is a multidisciplinary perspective on the impact of dynamics such as these on product promotion.
Learning Objective : Upon completion of this session, the participant should be able to:
Assess patient-focused drug development and FDA approval process per the 21st Century Cures Act
Comprehend multi-disciplinary perspectives on how clinical trial designs have evolved promotional practices
Describe current and future technological innovations that provide an increased focus on promotion to patients