The task force’s goal is to develop emerging good practice recommendations for designing prospective real-world studies that collect patient reported outcome (PRO) data.


Global regulators, payers, and policy makers have indicated that PRO data can provide valuable information on the effectiveness, safety and tolerability from the patient perspective. Currently, there are no regulatory, health technology appraisal guidance nor publications pertaining to the standardization of patient reported outcome (PRO) data usage in RW studies.

While several guidelines on the implementation of PROs exist, they mainly focus on randomized control trials (RCTs) or clinical practice. They provide little or no recommendations for the use of PROs in the context of RWE generation, which would address the needs of regulators and policy makers. Practicalities of PRO data collection in routine care and methods of its analysis often pose a challenge for RWE researchers.


Melanie Calvert, PhD, BSc

Professor of Outcomes Methodology, University of Birmingham
Birmingham, WOR, United Kingdom

Angela Rylands, PhD, BSc

International Outcomes Research Director, Kyowa Kirin
Marlow, BKM, United Kingdom

Leadership Group

Meriem H. Bouslouk, MSc, PhD

Desk Officer, Federal Joint Committee (G-BA)
Berlin, Germany

Onyeka Illoh

Outcomes Researcher / Team Lead (OND/DCOA), FDA
Silver Spring, MD, United States

Tom Keeley

Director, GSK
Bromsgrove, WOR, United Kingdom

Bellinda King-Kallimanis, MS, PhD, BSc

Director Patient-Focused Research, LUNGevity Foundation
Chicago, IL, United States

Antony Martin, MSc, BSc

HEOR Director, QC Medica
Liverpool, United Kingdom

Konrad Maruszczyk

PhD student, University of Birmingham, UK
Birmingham, West Midlands, United Kingdom

Gina Mazza

Assistant Professor of Biostatistics, Mayo Clinic
Scottsdale, AZ, United States

Daniel O'Connor

London, United Kingdom

John Peipert

Assistant Professor, Northwestern University
Oak Park, IL, United States

Jessica Roydhouse, PhD, BA, MPH

Select Foundation Senior Research Fellow in Health Services Research, Menzies Institute for Medical Research, University of Tasmania
Hobart, TAS, Australia

Claire Snyder, PhD

Professor, Johns Hopkins School of Medicine
Baltimore, MD, United States

Ellie Yelland, MSc, PhD, BSc

Researcher, Clinical Practice Research Datalink (CPRD)
London, United Kingdom
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