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Activity Number:
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568
- Simulation Report for Designing Adaptive Clinical Trials: Current Practices and Recommendations to Industry
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #323517
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View Presentation
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Title:
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Practical Considerations on Simulations for Adaptive Dose Escalation and Dose Ranging Trials
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Author(s):
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Inna Perevozskaya* and Alun Bedding and Vladimir Dragalin and Parvin Fardipour
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Companies:
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Glaxo SmithKline and Roche UK and Janssen R&D and ICON
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Keywords:
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dose-escalation ;
dose-response ;
oncology ;
adaptive design ;
simulation
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Abstract:
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Adaptive designs have been increasing in popularity over the past decade. Simulation is a critical tool to evaluate operating characteristics of these designs resulting in simulation report becoming important part of study-related documentation. This presentation will cover simulation report core structure for dose-escalation and dose-ranging studies. Dose-escalation designs are typically used in Phase 1 oncology studies. The key challenge of these studies is small sample size and restricted ability to move within the pre-selected set of doses due to the safety considerations. Dose-ranging studies usually pursue learning about dose-response relationship as one of its objectives and have greater freedom to move within dose space (below the MTD). The key purpose of simulation report is to document how well the chosen study design addresses study objectives and to provide some quantitative evidence of it. The format and contents of simulation report obviously will depend on the study objectives; in this presentation we will address what similarities and differences exist between dose-escalation and dose-ranging studies when it comes to simulation report.
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Authors who are presenting talks have a * after their name.
