Logistical Considerations for Integrating Patient-Reported Outcomes in Multiregional Clinical Trials

Abstract

Patient-reported outcomes (PROs) are increasingly used in clinical trials for a variety of purposes, including demonstration of efficacy as a primary endpoint. Study teams face many unique logistical challenges when implementing PROs in multiregional clinical trials, including in terms of the resources needed to create questionnaires, train staff in their use, andanalyze patient feedback to them. For example, creation and validation of novel questionnaires require special expertise. Being aware of such challenges early in the process will enable successful integration of PROs in multiregional clinical trials.