Biopharmaceutical Applied Statistics Symposium, Vol. 1: Design of Clinical Trials (ICSA Book Series in Statistics)
目次
1. A Statistical Approach to Clinical Trial Simulations.- 2. Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design.- 3. Adaptive Trial Design in Clinical Research.- 4. Best Practices and Recommendations for Trial Simulations Within the Context of Designing Adaptive Clinical Trials.- 5. Designing and Analyzing Recurrent Event Data Trials.- 6. Bayesian Methodologies for Response-Adaptive Allocation.- 7. Addressing High Placebo Response in Neuroscience Clinical Trials.- 8. Phase I Cancer Clinical Trial Design: Single and Combination Agents.- 9. Sample Size and Power for the Mixed Linear Model.- 10. Crossover Designs.- 11. Data monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures.- 12. Design and Data Analysis of Multiregional Clinical Trials (MRCT) – Theory and Practice.- 13. Multiregional Clinical Trials (MRCT).- 14. Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines.- 15. Development and validation of Patient-reported Outcomes.- 16. Interim Analysis of Survival Trials: Group Sequential Analyses and Conditional Power.