Simulation-based adjustment after exploratory biomarker subgroup selection in phase II
Author:
Affiliation:
1. Merck KGaA; Darmstadt Germany
2. Institute of Medical Biometry and Informatics; University of Heidelberg; Heidelberg Germany
3. Boehringer Ingelheim Pharma GmbH & Co. KG; Ingelheim Germany
Publisher
Wiley
Subject
Statistics and Probability,Epidemiology
Reference20 articles.
1. Methods for identification and confirmation of targeted subgroups in clinical trials: a systematic review;Ondra;Journal of Biopharmaceutical Statistics,2016
2. Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes;Tanniou;BMC Medical Research Methodology,2016
3. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500160523.pdf
4. A Bayesian approach to subgroup identification;Berger;Journal of Biopharmaceutical Statistics,2014
5. Estimation of treatment effect in a subpopulation: an empirical Bayes approach;Shen;Journal of Biopharmaceutical Statistics,2016
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