Kyte, D, Reeve, BB, Efficace, F et al. (9 more authors) (2016) 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. Quality of Life Research, 25 (2). pp. 359-362. ISSN 0962-9343
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Springer International Publishing Switzerland 2015. This is an author produced version of a paper published in Quality of Life Research. The final publication is available at Springer via http://dx.doi.org/10.1007/s11136-015-1099-z. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | International Society for Quality of Life Research; European Medicines Agency; Patient-reported outcomes; PROs; Health-related quality of life; HRQL; Oncology |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 16 Oct 2015 10:08 |
Last Modified: | 30 Oct 2016 18:09 |
Published Version: | http://dx.doi.org/10.1007/s11136-015-1099-z |
Status: | Published |
Publisher: | Springer Verlag |
Identification Number: | 10.1007/s11136-015-1099-z |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:90935 |