临床试验与透明化.ppt

2. 报告规范化：全球和中国 Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University 随机对照试验报告指南 David Moher和Doug Altman为首的CONSORT工作组 CONSORT family CONSORT statement: extension to cluster randomised trials CONSORT statement extension to the noninferiority and equivalence randomized trials CONSORT for Non-Pharmacologic Treatments CONSORT statement elaborated to herbal interventions CONSORT statement extension of harms CONSORT for reporting randomised trials in journal and conference abstracts CONSORT for TCM CONSORT-STRICTA Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University EQUATOR Network Enhancing the QUAlity and Transparency Of health Research2008年6月26日在英国皇家医学会启动 Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University 中国循证医学中心 GPP（Good Publication Practice) 与48家医学期刊发起成立“中国临床试验注册与发表协作网”（ChiCTRPC），现已发展到65家 宣布从2007年1月1日起优先发表已注册临床试验 医学期刊对推动医学研究水平可以发挥积极作用，欢迎广大核心期刊加入ChiCTRPC Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University WHO ICTRP “the findings of all clinical trials must be made publicly available” 赫尔辛基宣言（08版） Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University 推动我国医学期刊编辑与发表伦理学的发展 建立我国医学期刊编辑伦理网（Medical Journal Publication Ethics Network） 期望全国的核心期刊和统计源期刊联合起来共同推动我国医学期刊编辑与出版伦理学的发展与完善，促进提高临床试验质量 Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University 3.临床试验过程透明： 公共eCRF系统 Taixiang Wu, ChiCTR, Chinese EBM Centre, ChiCC, INCLEN CERTC, West China Hospital, Sichuan University eCRF 电子CRF系统：基于互联网的试验结果记录系统 公众可浏览试验检测数据，了解试验进程 多中心试验可统一管理、监测数据的可靠性 Taixiang Wu, ChiCTR