European Network of Gynaecological Trial, Geneva, Switzerland.
Int J Gynecol Cancer. 2013 Sep;23(7):1339-43. doi: 10.1097/IGC.0b013e31829b87da.
The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Earlier, we reported on the ENGOT minimal requirements for trials between academic groups and pharmaceutical companies. In this paper, we summarize the roadmap for performing trials in the ENGOT framework. In this roadmap, we define how an ENGOT trial should be set up and discuss the following items: What are the conditions to classify a study as an ENGOT trial? What is an ENGOT protocol? How are an ENGOT protocol, informed consent (ICF), and case report form (CRF) produced? How is the center selection and feasibility performed in ENGOT trials? How are regulatory and operational tasks handled? How should a confidentiality agreement between the industry and the whole ENGOT network be negotiated? How are contracts made between the industry and ENGOT and between ENGOT groups? How are funding, insurance, and communication flow arranged in ENGOT trials? What are the requirements for conducting substudies and what are the tasks for the leading group in an ENGOT trial? A template of a confidentiality agreement, a checklist of ENGOT criteria for new study proposals, and guidelines for authorship are also provided.
欧洲妇科肿瘤临床试验网络（ENGOT）是欧洲妇科肿瘤学会的一个研究网络，成立于 2007 年 10 月在柏林。在此之前，我们曾报道过学术团体与制药公司之间进行 ENGOT 试验的最低要求。在本文中，我们总结了在 ENGOT 框架内进行试验的路线图。在该路线图中，我们定义了如何设置 ENGOT 试验，并讨论了以下内容：将一项研究归类为 ENGOT 试验的条件是什么？什么是 ENGOT 方案？如何制定 ENGOT 方案、知情同意书（ICF）和病例报告表（CRF）？如何在 ENGOT 试验中进行中心选择和可行性评估？如何处理监管和运营任务？如何协商行业与整个 ENGOT 网络之间的保密协议？行业与 ENGOT 之间以及 ENGOT 各小组之间的合同如何订立？如何在 ENGOT 试验中安排资金、保险和沟通流程？开展子研究的要求是什么，以及在 ENGOT 试验中领导小组的任务是什么？本文还提供了保密协议模板、新研究提案的 ENGOT 标准检查表和作者指南。
