Objective

This task force’s goal is to revisit and update the good practice recommendations from the 2009 ISPOR ePRO Good Research Practices Task Force and the 2014 PRO Mixed Modes Good Research Practices Task Force reports in light of the accumulated evidence of measurement comparability between paper and electronic modes of PRO data collection and between different electronic modes of patient reported outcome measures (PROMs). The task force will provide recommendations related to mixing modes of administration, BYOD, and the need (or otherwise) to proactively demonstrate comparability between modes of administration.

Rationale

With the accumulation of evidence of measurement comparability between and among modes of data collection, as well as the US FDA’s encouragement of electronic data capture, it is appropriate to initiate a new ISPOR Good Practices Task Force to update the 2 previous ISPOR task force reports on the electronic implementation of PROMs in clinical trials (Coons et al 2009; Eremenco et al 2014) in order to provide stakeholders with best practice recommendations that reflect the growing evidence base.

Co-Chairs:

DonohoughPaul O’Donohoe, MSc
Scientific Lead, eCOA and Mobile Health, Medidata
London, England, UK

DD Reasneravid Reasner, PhD
Head, Data Science & Analytics, Imbria Pharmaceuticals
Boston, MA, USA 

Leadership Group

Valdo Arnera, MD

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

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

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

Sarrit Kovacs, PhD

Lead Clinical Analyst/Team Leader, Division of Clinical Outcome Assessment (DCOA), Office of Drug Evaluation Science, OND, CDER, 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

Sue Vallow, MBA, RPh, BS, MA

Executive Director, Patient Centered Outcomes / PCO Lead, Global Value and Access, Novartis Oncology
East Hanover, NJ, United States
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