Electronic Patient-Reported Outcome (ePRO) Consortium
Critical Path Institute has established the Electronic Patient-Reported Outcome (ePRO) Consortium, in cooperation with firms that provide electronic data collection technologies/services to the medical products industry for capturing patient-reported outcome (PRO) endpoints in clinical trials.
The mission of the ePRO Consortium is to advance the quality, practicality, and acceptability of electronic data capture (EDC) methods used in clinical trials for PRO endpoint assessment. To accomplish this mission, the provide a non-competitive, neutral environment to test the measurement equivalence of PRO measures migrated to or among alternative administration methods. The ePRO Consortium will work with the PRO Consortium to migrate the PRO instruments developed within the PRO Consortium to all relevant EDC platforms. Further, specification documents will be developed for the adaptation/migration of existing PRO instruments to the relevant EDC platforms. The Consortium also will provide guidance on methodological considerations for PRO instrument migration and adaptation.
The ePRO Consortium provides a pre-competitive space where a critical mass of experts can collaborate to generate measurement equivalence data, develop specification documents and data standards, and produce methodological guidance on measurement issues related to ePRO applications. The ePRO Consortium will work closely with C-Path's PRO Consortium, a group of 25 pharmaceutical companies working to develop novel PRO measures, to make the new measures available in multiple data collection formats. The overarching aim is to enhance public health by optimizing the value of PRO data in medical product evaluation and clinical decision making.
C-Path's role in the ePRO Consortium is to serve as a recognized and respected neutral third party that provides overall administrative support and oversight. C-Path provides a Director who is responsible for the overall management of the Consortium. The Director and his staff coordinate all projects and provide financial oversight, project management, and scientific oversight/consultation. Working with the ePRO Consortium participants, C-Path will facilitate the development and publication of scientific articles and supporting materials from the projects undertaken by the ePRO Consortium.