Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Tad Archambault, Principal, Virtu Stat, Ltd.
Speaker: Daniel Wachtlin, Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre Mainz
Blinded Sample Size Recalculation in Longitudinal Clinical Trials Using Generalized Estimating Equations
Daniel Wachtlin and Meinhard Kieser
Therapeutic Innovation & Regulatory Science, Vol. 47, Issue 4, pp. 460-467, 2013 Abstract | Paper+ | Slides
PSI Chair: Byron Jones, NOVARTIS
Speaker: Andrew Hartley, PPD
Adaptive blinded sample size adjustment for comparing two normal means—a mostly Bayesian approach
Andrew M. Hartley
Pharmaceutical Statistics, Vol. 11, Issue 3, pp. 230-240, 2012 Abstract | Paper+ | Slides
Discussant: Peiling Yang, Statistical Team Leader, Division of Biometrics I, US FDA Slides
+ Papers available to view from October 22nd 2013 to November 5th 2013.
For a flier advertising the event, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
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