Methods

The methodological framework for INCEPT is outlined in a core protocol, which covers:

1. The overaching design (a Bayesian, domain-based adaptive platform trial)

2. Core outcomes

3. General analytical principles

4. Adaptations (adaptive stopping and arm dropping for superiority/inferiority, practical equivalence, and/or futility, and response-adaptive randomisation)

5. The simulation framework used to design and evaluate the performance metrics of all INCEPT domains

Specific methodological choices are outlined in domain-specific appendices. In addition to the methodological framework behind itself, we develop tools and guidance aimed at facilitating the planning and conduct of adaptive (platform) trials by other researchers, and conduct studies assessing the use and implications of various methodological choices and adaptive design features.