PSI and DIA Journal Club: Statistical Considerations for Innovative Designs in Clinical Trials

  • Dates: 11 – 11 Dec, 2018
Time: 16:00 - 17:30 (UK Time)

Our next journal club, held jointly with the DIA, features two papers on the topic of Statistical Considerations for Innovative Designs in Clinical Trials. Please join us to hear Jason Yuan and Xiangmin Zhang present their recent work:


SPEAKER: Jason Yuan (Allergan)
Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addition to Group Sequential Test on Safety
Click here to view the presentation slides
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
Click here to view the presentation slides
Authors: Xiangmin Zhang, Yeh‐Fong Chen, Roy Tamura.
Pharmaceutical Statistics, Volume 17, Issue1, January/February 2018 Pages 25-37

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

REGISTER HERE:

https://attendee.gotowebinar.com/register/8012010784519787779
 

In preparation and prior to the day of the webinar, please follow the link above to obtain your personal dial in details and register with the webinar software. After registering via this link, you will receive a confirmation email containing information about joining the webinar, including details on how to dial-in via the telephone. Please allow enough time before joining to download the correct software.

Papers available to view prior to the meeting on http://www.psiweb.org/events/journal-club and presentation slides will be available a week before the JC.  Journal subscribers can access papers at any time.  Audio recordings will be available shortly after the JC to download from the PSI website. The meetings are open to PSI and non-PSI members.

We encourage you to read these papers in advance so you get the most from this event. For further info/feedback, or to submit a question to the authors in advance of the meeting please contact journalclub@psiweb.org

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