A multistage analysis strategy for a clinical trial to assess successively more stringent criteria for a primary endpoint with a low event rate

Author:

Li Siying1,Hussey Michael A.1,Schwartz Todd A.1,Koch Gary G.1

Affiliation:

1. Department of Biostatistics; University of North Carolina; Chapel Hill; NC; USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference12 articles.

1. FDA Guidance for industry: diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes Maryland 2008

2. Design and analysis of non-inferiority mortality trials in oncology;Rothmann;Statistics in Medicine,2003

3. Monitoring a clinical trial with multiple hypotheses concerning the treatment effect on a single primary endpoint;Denne;Statistics in Medicine,2001

4. Parks MH Clinical Perspectives on FDA Guidance for Industry: Diabetes Mellitus - Evaluating CV Risk in New Anti-diabetic Therapies to Treat T2DM 2009 www.fda.gov/downloads/Drugs/NewsEvents/UCM209087.pdf

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3. Adaptive design and timeline prediction for cardiovascular event trials for a non-inferiority/superiority claim;Communications in Statistics: Case Studies, Data Analysis and Applications;2015-04-03

4. An Overview of Statistical Planning to Address Subgroups in Confirmatory Clinical Trials;Journal of Biopharmaceutical Statistics;2014-01-02

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