Journal Club - Decision Rules


Our last event of 2015, sponsored by Wiley, was held in mid-December 2015, on the topic of Go/NoGo Decision Rules and Probability of Program Success.  We were pleased to coordinate with the DIA for this event, with speakers from Pharmaceutical Statistics and Therapeutic Innovation & Regulatory Science.  Listen again or catch up on the event here.

DIA Chair: Tad Archambault, Virtu Stat, Ltd.

Speaker: Ming Zhou, Amylin Pharmaceuticals
A Novel Design for Decision Rules Based on Statistical Testing Strategies of Binary Endpoints in a Definitive Go/No-Go Single-Treatment Clinical Study
Authors: Ming Zhou and Larry Z. Shen
Therapeutic Innovation & Regulatory Science, Vol. 48, Issue 3, pp. 327-335, 2014
Links: Abstract | Paper+ | Slides
PSI Chair: Sarah Bray, Amgen

: Meihua Wang, Merck Research Laboratories
Evaluation of program success for programs with multiple trials in binary outcomes
Authors: Meihua Wang, G. Frank Liu, and Jerald Schindler
Pharmaceutical Statistics, Vol. 14, Issue 3, pp. 172–179, 2015
Links: Abstract | Paper+ | Slides
Discussant: Fanhui Kong, FDA

+Papers available to view from December 8th 2015 to January 5th 2016.

For the flier advertising the event, please click here.


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