Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development

The ePRO Dataset Structure and Standardization Project is a multi-stakeholder initiative formed by Critical Path Institute ’s Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium to address issues related to electronic patient-reported outcome (ePRO) dataset structure and standardization and to provide best practice recommendations for clinical trial sponsors and elect ronic clinical outcome assessment (eCOA) providers. Given the many benefits of utilizing electronic modes to capture PRO data, clinical trials are increasingly using these methods, yet there are challenges to using data generated by eCOA systems.

Source: Value in Health - February 25, 2023 Category: International Medicine & Public Health Authors: Stacie Hudgens, Scottie Kern, Alexandra I. Barsdorf, Sally Cassells, Alison Rowe, Bellinda L. King-Kallimanis, Cheryl Coon, Geoff Low, Sonya Eremenco Tags: Policy Perspectives Source Type: research