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Table 1 Learning phase versus confirmatory phase investigations

From: Evolving landscapes in multiple sclerosis research: adaptive designs and novel endpoints

Learning Phase Paradigms

 

 • Adaptive dose-finding for toxicity (Bayesian or Frequentist)

 

 • Adaptive dose finding for efficacy (Bayesian or Frequentist)

 

 • Seamless phase I/IIa

 

Confirmatory Phase Paradigms

 

 • Group sequential

 

 • Sample size re-estimation

 

 • Adaptive randomization based on observed response

 

 • Adaptive randomization based upon covariate

 

 • Enrichment Designs

 

 • Adaptive treatment-switching design

 

 • Adaptive seamless phase II/III

 

Adaptive hypotheses

 

 • Superiority to non-inferiority