1.6 Opportunities and Challenges in Designing, Conducting, and Analyzing Adaptive Trials
1.6.1 Logistics in Trial Execution
Implementing an adaptive trial requires operational support on many fronts. These include a versatile randomization system, nimble drug supply management, data monitoring support, timely access to fit-for-use data, process and documentation control. A detailed document that describes the rationale and execution of the pre-planned adaptations should be prepared in advance. The document should also describe the interim analysis plan including who will conduct the interim analysis and whether an internal or external DMC will review the interim data. For confirmatory trials, access to interim results by the sponsor should be ...
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