Statistical Approaches for 'enriched' Trials Task Force Charter

Task 1.4.1 Establish Task Force & Scope (M1-M5) (LA-SER, GSK, SARD) The Task Force will include subject matter experts from industry, academia, regulators, HTAs, physicians and patients. The Task Force will be established by the Task Force Leaders based on the scope and structure as defined above. Potential experts will be identified from workshops conducted as part of the original GetReal project and contacted to explain the project, the expected outputs and invite them to participate in the Task Force. Once established, the group will develop a charter (D1.19) which documents the agreed ways of working, roles and responsibilities, clearly defined scope for the Guidelines/Best Practice Recommendations to be developed and a detailed project plan to facilitate delivery. This will include agreement on the tools and techniques to be assessed, definition of the questions to be addressed, a priori definition of confidence grades (grade A, B, C) for the guidance items and deliverables.