A generalized analytic solution to the win ratio to analyze a composite endpoint considering the clinical importance order among components

Author:

Dong Gaohong1,Li Di2,Ballerstedt Steffen3,Vandemeulebroecke Marc3

Affiliation:

1. iStats Inc.; Long Island City NY USA

2. Eisai Inc.; Woodcliff Lake NJ USA

3. Novartis Pharma AG; Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference26 articles.

1. EUnetHTA (European network for Health Technology Assessment) Endpoints used for relative effectiveness assessment of pharmaceuticals - Composite endpoints 2013 http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/ files/Composite\%20endpoints.pdf

2. Advanced multiplicity adjustment methods in clinical trials;Alosh;Statistics in Medicine,2014

3. Use of composite endpoints in clinical trials;Sankoh;Statistics in Medicine,2014

4. European Medicines Agency (EMA) Guideline on the evaluation of medicinal products for cardiovascular disease prevention 2008 http://www.ema.europa.eu/docs/en\_GB/document\_library/Scientific\_guideline/ 2009/09/WC500003290.pdf

5. European Medicines Agency (EMA) Points to consider on multiplicity issues in clinical trials 2002 http://www.ema.europa.eu/docs/en\_GB/document\_library/Scientific\_guideline/2009/09/ WC500003640.pdf

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