欧洲妇科肿瘤试验组织网络对学术团体与行业合作伙伴间试验的要求——2015年首次更新

European Network of Gynaecological Oncological Trial Groups' Requirements for Trials Between Academic Groups and Industry Partners--First Update 2015.

作者信息

du Bois Andreas, Reuss Alexander, Pujade-Lauraine Eric, Pignata Sandro, Ledermann Jonathan, Casado Antonio, Sehouli Jalid, Mirza Mansoor, Colombo Nicoletta, Marth Christian, Witteveen Els, Del Campo Jose, Calvert Paula, Aravantinos Gerassimos, Vardar Mehmet Ali, van der Zee Ate G J, Korach Jacob, Taskiran Cagatay, Fehr Mathias, Glasspool Ros, Pfisterer Jacobus, Cibula David, Vergote Ignace

机构信息

European Network of Gynaecological Oncological Trial Groups, Geneva, Switzerland.

出版信息

Int J Gynecol Cancer. 2015 Sep;25(7):1328-30. doi: 10.1097/IGC.0000000000000478.

DOI:10.1097/IGC.0000000000000478

PMID:26067859

Abstract

The first version of ENGOT's Requirements for Trials Between Academic Groups and Industry Partners in Europe was published 2010. This first update integrates the experiences made by the ENGOT network and the cooperative group studies while performing, analyzing, and publishing -among others - three large phase III trials. Furthermore, progress in European legislation and its impact on clinical studies in Europe have been considered in this update process.

摘要

欧洲妇科肿瘤试验组织（ENGOT）关于欧洲学术团体与行业合作伙伴间试验的要求的第一版于2010年发布。此次首次更新整合了ENGOT网络及合作组研究在开展、分析和发表三项大型III期试验等方面所积累的经验。此外，此次更新过程还考虑了欧洲立法的进展及其对欧洲临床研究的影响。