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