《临床试验方案纳入患者报告结局的指南-扩展声明》解读  

Interpretation of “the guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension”

作　　者：周慧 姚弥 陈杰[2] 陈孝[2] 陈艺莉[1] 陈崴[4] 元刚[1] ZHOU Hui;YAO Mi;CHEN Jie;CHEN Xiao;CHEN Yi-li;CHEN Wei;YUAN Gang(Phase Ⅰ Clinical Trial Center, the First Affiliated Hospital,Sun Yat-sen University,Guangzhou 510080,China;Department of Pharmacy,the First Affiliated Hospital,Sun Yat-sen University,Guangzhou 510080,China;Institute of Applied Health Research,University of Birmingham,Birmingham B1527T,UK;Nephrology Department,the First Affiliated Hospital,Sun Yat-sen University,Guangzhou 510080,China)

机构地区：[1]中山大学附属第一医院Ⅰ期临床试验中心,广州510080 [2]中山大学附属第一医院药学部,广州510080 [3]英国伯明翰大学应用卫生研究院,伯明翰B152TT [4]中山大学附属第一医院肾内科,广州510080

出　　处：《中国新药杂志》2021年第14期1296-1301,共6页Chinese Journal of New Drugs

基　　金：国家自然科学基金面上资助项目(81772699);广东省自然科学基金资助项目(2018A030313138);广东省药学会医院药学研究基金资助项目(2018HS06)。

摘　　要：临床试验的患者报告结局(patient-reported outcome, PRO)可为医患共同决策、药品标示说明、临床指南和卫生政策提供有价值的参考,然而目前的临床试验方案对PRO重视度仍不足。《规范临床试验方案内容声明》(Standard Protocol Items:Recommendations for Interventional Trials, SPIRIT)依据循证医学原理,通过简洁指引条目提高临床试验方案的完整性。然而,该声明并未提供PRO相关的详细内容。新的SPIRIT-PRO指南为临床试验方案中PRO提供详细指引。这些指引将PRO作为主要研究终点或关键的次要研究终点。在临床研究方案设计中纳入PRO,可以提高研究质量,也有助于以患者为中心的治疗。本文对《临床试验方案中纳入患者报告结局的指南-扩展声明》重点内容进行分析和解读,包括临床试验中PRO数据的管理、收集、分析的规范性方法等内容,以期为临床试验工作者提供参考。Patient-reported outcome(PRO) data from clinical trials is strong evidence which can inform shared decision-making, labeling claims, clinical guidelines, and health policy;however, those data is often not given enough emphasis to in current clinical trial protocols. The "Standard Protocol Items: Recommendations for Interventional Trials"(SPIRIT) statement, using the most concise items by providing evidence-based medicine, aims to improve the completeness of trial protocols. However, it does not provide guidance on PRO content. The SPIRIT-PRO Extension provides minimum requirements for PRO which will be used as the primary or key secondary study endpoint in clinical trials. Improved design of clinical trials including PRO could help ensure high-quality data that may inform patient-centered care. We interpreted the key contents of this extension, including the normative methods for the management, collection and analysis of PRO data, in order to provide references for clinical trial researchers.

关 键 词：临床试验 临床试验方案 患者报告结局 指南 

分 类 号：R969.4[医药卫生—药理学]