Bayesian predictive power for interim adaptation in seamless phase II/III trials where the endpoint is survival up to some specified timepoint

Author:

Schmidli Heinz,Bretz Frank,Racine-Poon Amy

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference27 articles.

1. Anonymous. Innovation/Stagnation: Challenge and opportunity on the critical path to new medical products. FDA Report, http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html [March 2004].

2. Anonymous. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials with Flexible Design and Analysis Plan. EMEA (European Medicines Agency), Committee for Medicinal Products for Human Use [Draft 3/23/2006].

3. Seamlessly Expanding a Randomized Phase II Trial to Phase III

4. Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts

5. Adaptive Modifications of Hypotheses After an Interim Analysis

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