Methodological issues in confirmatory clinical trials planned with an adaptive design - Scientific guideline
VeterinaryScientific guidelines
This document focuses on the opportunities for interim trial design modifications, and the prerequisites, problems and pitfalls that must be considered as soon as any kind of flexibility is introduced into a confirmatory clinical trial intended to provide evidence of efficacy.
Keywords: Adaptive design, interim analyses, design modifications, randomised clinical trials, Confirmatory clinical trials, biostatistics