To update the good practice recommendations from the 2009 ISPOR Good Practices Task Force Reports on the evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures and the 2014 report on PRO data collection in clinical trials using mixed modes. The task force will provide recommendations related to mixing modes of administration, BYOD, and the need to proactively demonstrate comparability between modes of administration.
The accumulation of evidence and the ever-evolving technology landscape that demands rigor to ensure the integrity of clinical trial data drive the need for updated recommendations that reflect the current evidence base. In addition, FDA is encouraging the capture of source data in an electronic format to streamline and modernize clinical trials. Paper-based PROMs continue to be migrated onto electronic platforms in growing numbers. Newly created PROMs, while increasingly developed in electronic formats from the beginning, are deployed across a range of platforms. Finally, the rise of “Bring Your Own Device” (BYOD) methodologies, where PROMs may be completed by participants using their personal devices, has paved the way for data within a single trial captured on a range of different device types. Hence, good practice recommendations should be updated and used to facilitate the electronic capture of PROM-based endpoints in clinical trials, while still ensuring the integrity of the data being captured.
Paul O’Donohoe, MSc
Scientific Lead, eCOA and Mobile Health, Medidata
London, England, UK
David Reasner, PhD
Head, Data Science & Analytics, Imbria Pharmaceuticals
Boston, MA, USA