Roadmap for the European Network of Gynaecological Trial groups (ENGOT) Trials.

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.