Adaptive Design Theory and Implementation Using SAS and R (2nd Ed.) Chapman & Hall/CRC Biostatistics Series
Auteur : Chang Mark
Get Up to Speed on Many Types of Adaptive Designs
Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials.
New to the Second Edition
- Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more
- More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching
- New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials
- Twenty new SAS macros and R functions
- Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials
Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.
Introduction. Classic Design. Theory of Hypothesis-Based Adaptive Design. Method with Direct Combination of P-Values. Method with Inverse-Normal P-Values. Adaptive Non-Inferiority Design with Paired Binary Data. Trial Design and Analysis with Incomplete Paired Data. Implementation of N-Stage Adaptive Designs. Conditional Error Function Method and Conditional Power. Recursive Adaptive Design. Unblinded Sample-Size Re-Estimation Design. Blinded Sample Size Re-Estimation. Adaptive Design with Co-Primary Endpoint. Multiple-Endpoint Adaptive Design. Pick-the-Winners Design. The Add-Arms Design for Unimodal Response. Biomarker-Adaptive Design. Biomarker-Informed Adaptive Design. Survival Modeling and Adaptive Treatment Switching. Response-Adaptive Allocation Design. Bayecian Adaptive Dose Finding Design. Bayesian Phase I-II Adaptive Design. Adaptive Design for Biosimilarity Trial. Multi-Regional Adaptive Trial Design. Bayesian Adaptive Design. Planning, Execution, Analysis, and Reporting. Data Analysis of Adaptive Design. Debates in Adaptive Designs. SAS Adaptive Design Modules: SEQDESIGN Procedure. Appendices. Bibliography. Index.
Date de parution : 10-2016
15.6x23.4 cm
Disponible chez l'éditeur (délai d'approvisionnement : 14 jours).
Prix indicatif 71,13 €
Ajouter au panierDate de parution : 01-2015
Ouvrage de 664 p.
15.6x23.4 cm
Thèmes d’Adaptive Design Theory and Implementation Using SAS and R :
Mots-clés :
Interim Analysis; SAS Macro; methodology and application of adaptive trials; Adaptive Design; adaptive design methods in clinical trials; Sample Size Reestimation; biomarker-informed adaptive design; Stopping Boundaries; blinded and semi-blinded sample size reestimation design; Group Sequential Design; adaptive multiregional trial design; SAS Macro Call; SAS and R for group sequential design; Error Spending Function; Bayesian approaches to clinical trials; SAS Variable; seamless phase II/III trial design; Adaptive Trials; dose-escalation design; Conditional Error Function; SAS and R simulations; Futility Boundary; data analysis in adaptive trials; Conditional Power; adaptive treatment switching; Posterior Distribution; sequential parallel designs with rerandomization; Phase Ii Trial; multiple-endpoint adaptive design; Conditional Error Rates; survival modeling; Coprimary Endpoints; Seamless Design; Final Test Statistic; Drop Loser Design; Sample Size Calculation; Expected Sample Sizes; Sample Size Adjustment; Adaptive Design Methods; Noninferiority Margin