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09:30 to 10:00 |
Registration, Tea and Coffee |
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10:00 to 10:15 |
Welcome and Introduction |
John Toland (University of Cambridge), (University of Bath), (Isaac Newton Institute) |
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10:15 to 10:45 |
Design of Experiments for IMI2 Strategic Research Agenda "The Right Prevention and Treatment for the Right Patient at the Right Time" |
Vladimir Dragalin (ClinResearch) |
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10:45 to 11:15 |
IDeAL (Integrated DEsign and AnaLysis of small population group trials) - A Collaborative Approach between Industry and Academia |
Dieter Hilgers (RWTH Aachen University) |
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11:15 to 11:30 |
Tea and Coffee |
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11:30 to 12:00 |
Accoutning for Parameter Uncertainty in Two-Stage Designs for Phase II Dose-Response Studies |
Bjoern Bornkamp (Novartis Institutes for Biomedical Research) |
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12:00 to 12:30 |
Adaptive Dose Finding Designs in the Presence of Model Uncertainty |
Tobias Mielke (Otto-von-Guericke-Universität Magdeburg) |
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12:30 to 13:00 |
Confirmatory Testing for a Beneficial Treatment Effect in Dose-Response Studies using MCP-Mod and an Adaptive Interim Analysis |
Franz König (Medical University of Vienna) |
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13:00 to 13:45 |
Lunch |
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13:45 to 14:15 |
Bayesian Adaptive Randomisation Revisited |
Andy Grieve (ClinResearch) |
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14:15 to 14:45 |
Brick Tunnel Randomisation, Overcoming Inconvenient Allocation Ratio |
Yevgen Tymofyeyev (Janssen Pharmaceuticals) |
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14:45 to 15:15 |
Optimal Design of Clinical Trials with Censoring Driven by Random Enrollment |
Valerii Fedorov (Icon PLC) |
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15:15 to 15:30 |
Tea and coffee |
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15:30 to 16:00 |
Sequential Parallel Comparision Design for Trials with High Placebo Response: Overview and Case Studies |
Anastasia Ivanova (University of North Carolina ) |
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16:00 to 16:30 |
Regulatory Aspects of Adaptive Clinical Trial Designs: Perspectives from Scientific Advice to Marketing Authorisation Applications |
Frank Petavy (European Medicines Agency)
Olivier Collignon (European Medicines Agency) |
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16:30 to 17:00 |
Open Discussion and Questions |
Vladimir Dragalin (ClinResearch) |
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