Statistical Considerations for Innovative Designs in Clinical Trials

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Tuesday 11 December 2018, 04:00pm

Location Online

Discussants: Dr. Jim Hung (FDA) and Peter Zhang (Otsuka)

Speaker: Jason Yuan (Allergan)
Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addition to Group Sequential Test on Safety
Authors: Jiacheng Yuan, Peter Mesenbrink, Jihao Zhou, Jeen Liu, Ray Zhu, and Gary Koch.
Therapeutic Innovation & Regulatory Science 2018, Vol. 52(6) 690-695

Speaker: Xiangmin Zhang (FDA)
The plan of enrichment designs for dealing with high placebo response
Authors: Xiangmin Zhang, Yeh?Fong Chen, Roy Tamura.
Pharmaceutical Statistics, Volume 17, Issue1, January/February 2018 Pages 25-37

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