A practical guide to Bayesian group sequential designs-Reference-Cited by-同舟云学术

A practical guide to Bayesian group sequential designs

Published:2013-08-24 Issue:1 Volume:13 Page:71-80
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Gsponer Thomas¹,Gerber Florian¹,Bornkamp Björn²,Ohlssen David³,Vandemeulebroecke Marc⁴,Schmidli Heinz²

Affiliation:

1. Institute of Social and Preventive Medicine; University of Bern; Bern Switzerland

2. Statistical Methodology; Novartis Pharma AG; Basel Switzerland

3. Statistical Methodology; Novartis Pharmaceuticals Corporation; East Hanover, NJ USA

4. Integrated Information Sciences; Novartis Pharma AG; Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference41 articles.

1. ICH E9 statistical principles for clinical trials 1998 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf

2. EMA Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design 2007 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003616.pdf

3. FDA Adaptive design clinical trials for drugs and biologics (draft) 2010 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf

4. The Design and Analysis of Sequential Clinical Trials.

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