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CC = Baltimore Convention Center,    H = Hilton Baltimore
* = applied session       ! = JSM meeting theme

Activity Details

568 * ! Wed, 8/2/2017, 2:00 PM - 3:50 PM CC-311
Simulation Report for Designing Adaptive Clinical Trials: Current Practices and Recommendations to Industry — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): cristiana mayer, Janssen R&D
Chair(s): Sergei Leonov, ICON Clinical Research
2:05 PM Current Practices in Reporting Trial Simulations for Adaptive Study Designs cristiana mayer, Janssen R&D ; Parvin Fardipour, ICON
2:25 PM Practical Considerations on Simulations for Adaptive Dose Escalation and Dose Ranging Trials Inna Perevozskaya, Glaxo SmithKline ; Alun Bedding, Roche UK ; Vladimir Dragalin, Janssen R&D ; Parvin Fardipour, ICON
2:45 PM Simulation Considerations for Multistage Adaptive Designs and Designs with Sample Size Re-Estimation: Type 1 Error Control and Beyond Greg Cicconetti, Abbvie ; Sergei Leonov, ICON Clinical Research ; Yili L Pritchett, MedImmune ; Michael Smith, Astellas ; Alan Hartford, AbbVie
3:05 PM Evaluation of Simulation Models Through Different Computational Environments Jiang Hu, FDA
3:25 PM Discussant: Boguang Zhen, FDA CBER
3:45 PM Floor Discussion
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