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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
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Kyte, Derek, Reeve, Bryce B., Efficace, Fabio, Haywood, Kirstie L., Mercieca-Bebber, Rebecca, King, Madeleine T., Norquist, Josephine M., Lenderking, William R., Snyder, Claire, Ring, Lena, Velikova, Galina and Calvert, Melanie (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. 359-62. doi:10.1007/s11136-015-1099-z ISSN 0962-9343.
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Official URL: http://dx.doi.org/10.1007/s11136-015-1099-z
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.
Item Type: | Journal Article | ||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing > Royal College of Nursing Research Institute (RCN) (- July 2017) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Quality of Life Research | ||||||||
Publisher: | Springer Netherlands | ||||||||
ISSN: | 0962-9343 | ||||||||
Official Date: | February 2016 | ||||||||
Dates: |
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Volume: | 25 | ||||||||
Number: | 2 | ||||||||
Page Range: | pp. 359-62 | ||||||||
DOI: | 10.1007/s11136-015-1099-z | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Restricted or Subscription Access |
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