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Adaptive Design Ana Ruiz Paul Bycott
Definition ,[object Object],[object Object]
Advantages and Disadvantages ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Implications ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
Summary of key positions from EMEA/EFPIA workshop on adaptive designs in confirmatory trials, December 2007 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Members: EU and US regulators, academia and industry experts
Applications in Oncology ,[object Object],[object Object],[object Object]
Adaptive Dose Finding ,[object Object],[object Object]
Huang et al. ,[object Object],[object Object]
Simulation of 24 patients treated sequentially in 8 cohorts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Target probablity of DLT:0.33. dose level 6 true MTD.  Set 30%, 50% and 70% as the post quantiles of the MTD
Performance analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sample size re-estimation ,[object Object],[object Object],[object Object],[object Object],[object Object]
Adaptive Statistical Analysis Following Sample Size Modification Based on Interim Review of Effect Size (James Hung) ,[object Object],[object Object]
Methodology ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Seamless Phase II/III Designs ,[object Object],[object Object]
Brannath et al. Target therapy in Oncology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Point of estimation: Sub-population  ,[object Object],[object Object]
Point of estimation: treatment effect ,[object Object],[object Object]
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],This approach is discussed in CHMP reflection paper on “Methodological issues in confirmatory Clinical trials planned with an adaptive design” 2007; available at : www.emea.europa.eu/pdfs/human/ewp/245902enadopted.pdf
Back-ups
Endpoints ,[object Object],[object Object],[object Object],[object Object]
Type I error ,[object Object],[object Object],[object Object]
Dose Finding ,[object Object]
Brannath et al. Target therapy in Oncology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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ADAPTIVE DESIGNS IN ONCOLOGY