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
Scientific Advisor and General Manager, ERT Geneva,
Geneva, Switzerland  

Alexandra I Barsdorf, PhD
Director, Clinical Outcomes Solutions
New York, NY, USA

Serge Bodart, MSc
Chief Commercial Officer (CCO) at IDDI and
Independent eCOA Subject Matter Expert
Brussels, Belgium

Stephen Joel Coons, PhD
Executive Director, Patient-Reported Outcome (PRO) Consortium and
Program Officer, Clinical Outcome Assessment Program
Critical Path Institute
Tucson, AZ, USA 

Bill Byrom, PhD
Vice President, Product Strategy and Innovation
Signant Health
London, England, UK

Sonya Eremenco, MA
Acting Director, Electronic Patient-Reported Outcome (ePRO) Consortium and
Associate Director, Patient-Reported Outcome (PRO) Consortium
Critical Path Institute
Tucson, AZ, USA

Sarrit Kovacs, PhD
Lead Clinical Analyst/Team Leader, Division of Clinical Outcome Assessment (DCOA)
Office of Drug Evaluation Science, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA)
Silver Spring, MD, USA   

Jean Paty, PhD
Vice President, Patient-Centered Endpoints, Real-World and Analytic Solutions
QuintilesIMS
New York, NY, USA  

Megan Turner, BA
Scientist, COA Implementation
GSK
Collegeville, PA, USA

Sue Vallow, MBA, MA
Executive Director, Patient-Centered Outcomes / PCO Lead, Global Value and Access,
Novartis Oncology
East Hanover, NJ, USA    

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