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.
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.
Primary Care and Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Derek
D
Kyte
Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
Bryce B
BB
Reeve
Italian Group for Adult Hematologic Diseases (GIMEMA), Health Outcomes Research Unit, Rome, Italy.
Fabio
F
Efficace
Royal College of Nursing Research Institute, Warwick Medical School, Warwick University, Coventry, UK.
Kirstie
K
Haywood
Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Sydney, Australia.|Sydney Medical School, University of Sydney, Sydney, Australia.
Rebecca
R
Mercieca-Bebber
Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Sydney, Australia.|Sydney Medical School, University of Sydney, Sydney, Australia.
Madeleine T
MT
King
Merck Sharp & Dohme, Corp., North Wales, PA, USA.
Josephine M
JM
Norquist
Evidera, Lexington, MA, USA.
William R
WR
Lenderking
Johns Hopkins School of Medicine, Baltimore, MD, USA.
Claire
C
Snyder
Department of Usages, Medical Products Agency, Uppsala, Sweden.
Lena
L
Ring
Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
Galina
G
Velikova
Primary Care and Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. M.Calvert@bham.ac.uk.
Melanie
M
Calvert
D005060:Europe; D006801:Humans; D008495:Medical Oncology / Q000379:methods*; D009369:Neoplasms / Q000628:therapy*; D063868:Patient Outcome Assessment; D011788:Quality of Life; D012106:Research; D057566:Self Report
European Medicines Agency; HRQL; Health-related quality of life; International Society for Quality of Life Research; Oncology; PROs; Patient-reported outcomes