Biopharmaceutical Applied Statistics Symposium Volume 1 Design of Clinical Trials /

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments - particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied S...

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Médium: Elektronický zdroj E-kniha
Jazyk:angličtina
Vydáno: Singapore : Springer Singapore , 2018.
Vydání:1st ed. 2018.
Edice:ICSA Book Series in Statistics,
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ISBN:9789811078293
ISSN:2199-0980
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Obsah:
  • 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.