Streamlining the Validation of Patient Reported Outcome (PRO) Measures in Drug Regulatory Processes

摘要

The context and setting in which patient-reported outcome (PRO) measures applied in drug development programmes are developed and applied are undergoing rapid changes. The emergence of social media, coupled with advancement of patient-centred methodologies, has led to more connected and empowered patients than before. Drug regulatory agencies are beginning to embrace a new role as collaborators in the drug development process, and new models for defining core outcomes in various disease areas are emerging. Technological advances and social changes have led to the wide use of personal gadgets with greater internet connectivity and computing power than most computers had a generation ago. To explore how progress in the measurement of PROs might be achieved amidst such changes, lessons were drawn from the PRO labelling claims reviewed by the US FDA following the publication of the PRO guidance in 2009. In addition, semi-structured interviews were carried out with seven experts working with drug regulatory agencies and in the pharmaceutical industry to identify major issues and possible solutions.