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Adaptive Design

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Adaptive designs allow modifications to clinical trials as they are ongoing based on accumulating data without undermining validity. This speeds learning and application of knowledge while maintaining scientific standards. Key benefits include faster drug development and efficient use of resources, though statistical complexity is increased. Sample size re-estimation and seamless phase II/III designs are two applications that maintain rigor while adding flexibility.

TechnologyHealth & Medicine
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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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