Patient-reported Outcome:Comparison between the Domestic and the Global Application Progress
闾承辰, and
School of International Pharmaceutical Business, China pharmaceutical university,International Pharmaceutical School of Business, China Pharmaceutical University,
[1] Acquadro C, Berzon R, Dubois D, et al. Incorporating the patient’s perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration[J]. Value in Health.2003(6): 522–31. [2][6] Ari Gnanasakthy, Margaret Mordin, Marci Clark, et al. A review of patient-reported outcome labels in the United States: 2006 to 2010[J]. Value in Health. 2012 (15): 437-442. [3] 任君, 周芬, 杨国彦, 刘建平.患者报告结局指标的优越性与局限性[C]. 第八届中医/中西医结合循证医学方法研讨会会议材料,2014(6):153-155. [4] 李明晖, 刘国恩, 马爱霞. 中国城乡居民健康相关生存质量研究[J].2010(03): 22-35. [5] 陈薇, 刘建平. 临床研究中的患者报告结局[J]. 2009(8): 746-749. [6] Nick Black. Patient-reported outcome measures could help transform healthcare [J].British Medical Journal, 2013(1): 1-5 [7] Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims[Z], Dec. 2009 [8] Carla DeMuro, Marci Clark Margaret Mordin, Sheri Fehnel, et al. Reasons for Rejection of Patient-Reported Outcome Label Claims: A Compilation Based on a Review of Patient-Reported Outcome Use among New Molecular Entities and Biologic License Applications,2006 –2010 [J]. Value in Health. 2012(15): 443-448. [9] Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, L?gar? F, Montori VM, et al. Shared decision making: really putting patients at the centre of healthcare. BMJ 2012;344: e256.