International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies

Research output: Contribution to journalArticle

Authors

  • Bryce B. Reeve
  • Fabio Efficace
  • Kirstie Haywood
  • Rebecca Mercieca-Bebber
  • Madeleine T. King
  • Josephine M. Norquist
  • William R. Lenderking
  • Claire Snyder
  • Lena Ring
  • Galina Velikova

Colleges, School and Institutes

External organisations

  • Centre for the Study of Choice (CenSoC), University of Technology Sydney, Sydney, Australia.
  • University of Leeds
  • Warwick Medical School
  • Department of Radiation Oncology and Molecular Radiation Sciences and The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21231, USA.
  • Merck Sharp & Dohme Corp
  • Division of Rheumatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
  • UNIVERSITY OF SYDNEY
  • Institute of Cell Engineering, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
  • Department of Health Policy and Management
  • Gillings School of Global Public Health
  • Italian Group for Adult Hematologic Diseases (GIMEMA)
  • Health Outcomes Research Unit
  • Royal College of Nursing Research Institute, Warwick Medical School, Warwick University
  • Psycho-oncology Co-operative Research Group
  • Sydney Medical School
  • Evidera
  • Department of Usages
  • Medical Products Agency
  • Leeds Institute of Cancer and Pathology

Abstract

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

Details

Original languageEnglish
Pages (from-to)359–362
JournalQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
Volume25
Issue number2
Publication statusE-pub ahead of print - 15 Aug 2015

Keywords

  • European Medicines Agency, Health-related quality of life, HRQL, International Society for Quality of Life Research, Oncology, Patient-reported outcomes, PROs