Discussant: Dr Ram Tiwari, FDA
Speaker: : Dr Patrick Schnell (The Ohio State University College of Public Health, Columbus Ohio)
A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data
Authors: Patrick Schnell, Greg Ball
Therapeutic Innovation – Regulatory Science, Vol 50(6), p833-838, 2016
Speaker: Dr Hui Quan (Sanofi, New Jersey)
Adaptive and repeated cumulative meta-analyses of safety data during a new drug development process
Authors: Hui Quan, Yingqui Ma, Yan Zheng, Meehyung Cho, Christelle Lorenzato, Carole Hecquet
Pharmaceutical Statistics, Vol 14, Issue 3, May/June 2015
For each of these published papers there will be a 20 min presentation by the author followed by a 20-25 min discussion
Papers available to view prior to the meeting on http://www.psiweb.org/events/journal-club and presentation slides will be available there to download 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 above website.
Click Here for the webinar flyer
Open to PSI and non-PSI members and DIA and non-DIA members – no need to pre-register. We encourage you to read these papers in advance so you get the most from this event. Where multiple people are dialling in from the same site, we encourage you to book a meeting room and dial in together. For further info/feedback, or if you would like to submit a question to the authors in advance of the meeting please contact journalclub@psiweb.org
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