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

Kyte D; Reeve BB; Efficace FHaywood KMercieca-Bebber RKing MTNorquist JMLenderking WRSnyder CRing LVelikova GCalvert M

首页> 外文期刊>Quality of life research: An international journal of quality of life aspects of treatment, care and rehabilitation >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

【24h】

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

机译：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

获取原文

获取原文并翻译 | 示例

掌桥外文数据库（机构版） >>

开具论文收录证明 >>

文献代查 >>

页面导航

摘要
著录项
相关主题

摘要

abstract_textpIn 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./p/abstract_text

著录项

来源
《Quality of life research: An international journal of quality of life aspects of treatment, care and rehabilitation》 |2016年第2期|359-362|共4页
作者
Kyte D; Reeve BB; Efficace FHaywood KMercieca-Bebber RKing MTNorquist JMLenderking WRSnyder CRing LVelikova GCalvert M;
展开▼
作者单位

University of Birmingham,Univ Birmingham;

University of North Carolina,Univ N Carolina;

Hlth Outcomes Res Unit,Italian Grp Adult Hematol Dis GIMEMAUniversity of Warwick,Univ WarwickUniversity of Sydney,Univ SydneyMerck & Company,Merck Sharp & Dohme CorpEvideraJohns Hopkins University,Johns Hopkins Sch MedDept Usages,Med Prod AgcyUniversity of Leeds,Univ Leeds;

展开▼
收录信息
原文格式 PDF
正文语种英语
中图分类医药、卫生;
关键词
International Society for Quality of Life Research; European Medicines Agency; Patient-reported outcomes; PROs; Health-related quality of life; HRQL; Oncology; RHEUMATOID-ARTHRITIS; PUBLIC INVOLVEMENT; FATIGUE; TRIALS; HEALTH;

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

摘要

著录项

相关主题

期刊订阅