Objective

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.

Rationale

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.


Co-Chairs:

Paul O'Donohoe

Paul O'Donohoe, MSc

Senior Director, eCOA Product and Science, Medidata
London, United Kingdom
David Reasner

David Reasner, PhD

Division Director, Division of Clinical Outcome Assessment, DCOA|ODES|OND|CDER, FDA at U.S. Department of Health and Human Services, US Food and Drug Administration
Moultonborough, NH, United States

Leadership Group

Valdo Arnera, MD

General Manager, ERT Geneva, ERT
Aubonne, VD, Switzerland

Alexandra Barsdorf, PhD

Senior Director, Clinical Outcomes Assessment, Clinical Outcomes Solutions
Tucscon, AZ, United States

Serge Bodart, MSc

Chief Commercial Officer, IDDI
Beaconsfield, QC, Canada

Bill Byrom, PhD, BSc

Vice President of Product Strategy and Innovation, Signant Health
Nottingham, NTT, United Kingdom

Stephen Joel Coons, PhD

Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute
Koloa, HI, United States

Sonya Eremenco, MA

Executive Director, PRO Consortium, Critical Path Institute
Tucson, AZ, United States

Sarrit Kovacs, PhD

Clinical Reviewer, Division of Gastroenterology (DG), Office of Immunology and Inflammation (OII), OND, CDER, FDA (formerly Division of Clinical Outco, FDA
Silver Spring, MD, United States

Jean Paty, MS, PhD

Vice President, Consulting Services, IQVIA
New York, NY, United States

Megan Turner, BA

PCO Scientist COA Implementation, GlaxoSmithKline
Collegeville, PA, United States

Susan Vallow, MBA, RPh, BS, MA

Exec. Director, Patient Centered Outcomes, Novartis Oncology
East Hanover, NJ, United States
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