Introductory adaptive trial designs: a practical guide with R Chang, Mark
Material type: TextSeries: Chapman and Hall/CRC biostatistics seriesPublication details: Boca Raton, CRC Press 2015Description: xiii, 218 pISBN:- 9781498717465
- 610.724 C4I6
Item type | Current library | Collection | Call number | Status | Date due | Barcode | Item holds | |
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Book | Ahmedabad | Non-fiction | 610.724 C4I6 (Browse shelf(Opens below)) | Available | 190944 |
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610.72 S4H3 Health intervention research: understanding research design and methods | 610.72 S8E8-2012 Essentials of biostatistics in public health | 610.724 C4A2-2012 Adaptive design methods in clinical trials | 610.724 C4I6 Introductory adaptive trial designs: a practical guide with R | 610.724 H2I6 Introduction to research methods and data analysis in the health sciences | 610.724 P3W4 When experiments travel: clinical trails and the global search for human subjects | 610.727 A2/2015 Advanced medical statistics |
Table of Contents:
1. Introduction
Motivation
Adaptive Designs in Clinical Trials
Clinical Trial Simulation
Characteristics of Adaptive Designs
FAQs about Adaptive Designs
2. Classical Design
Introduction
Two-Group Superiority
Two-Group Noninferiority Trial
Two-Group Equivalence Trial
Trial with Any Number of Groups
Multigroup Dose-Finding Trial
Summary and Discussion
3. Two-Stage Adaptive Confirmatory Design Method
General Formulation
Method Based on Sum of p-Values
Method with Product of p-Values
Method with Inverse-Normal p-Values
Comparisons of Adaptive Design Methods
4. K-Stage Adaptive Confirmatory Design Methods
Test Statistics
Determination of Stopping Boundary
Error-Spending Function
Power and Sample Size
Error Spending Approach
5. Sample-Size Reestimation Design
Sample Size Reestimation Methods
Comparisons of SSR Methods
K-Stage Sample Size Reestimaion Trial
Summary
6. Special Two-Stage Group Sequential Trials
Event-Based Design
Equivalence Trial
Adaptive Design with Farrington-Manning Margin
Noninferiority Trial with Paired Binary Data
Trial with Incomplete Paired Data
Trial with Coprimary Endpoints
Trial with Multiple Endpoints
7. Pick-the-Winners Design
Overview of Multiple-Arm Designs
Pick-the-Winner Design
Stopping Boundary and Sample Size
Summary and Discussion
8. The Add-Arms Design
Introduction
The Add-Arm Design
Clinical Trial Examples
Extension of Add-Arms Designs
Summary
9. Biomarker-Adaptive Design
Taxonomy
Biomarker-Enrichment Design
Biomarker-Informed Adaptive Design
Summary
10. Response-Adaptive Randomization
Basic Response-Adaptive Randomizations
Generalized Response-Adaptive Randomization
Summary and Discussion
11. Adaptive Dose-Escalation Trial
Oncology Dose-Escalation Trial
Continual Reassessment Method
Alternative Form CRM
Evaluation of Dose-Escalation Design
Summary and Discussion
12. Deciding Which Adaptive Design to Use
Determining the Objectives
Determining Design Parameters
Evaluation Matrix of Adaptive Design
13. Monitoring Trials and Making Adaptations
Stopping and Arm-Selection
Conditional Power
Sample-Size Reestimation
New Randomization Scheme
14. Data Analyses of Adaptive Trials
Orderings in Sample Space
Adjusted p-Value
Parameter Estimation
Confidence Interval
Summary
15. Planning and Execution
Study Planning
Working with a Regulatory Agency
Trial Execution
Summary
Appendix A: Thirty-Minute Tutorial to R
Appendix B: R Functions for Adaptive Designs
Bibliography
Index
All the Essentials to Start Using Adaptive Designs in No Time
Compared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time. Introductory Adaptive Trial Designs: A Practical Guide with R motivates newcomers to quickly and easily grasp the essence of adaptive designs as well as the foundations of adaptive design methods.
The book reduces the mathematics to a minimum and makes the material as practical as possible. Instead of providing general, black-box commercial software packages, the author includes open-source R functions that enable readers to better understand the algorithms and customize the designs to meet their needs. Readers can run the simulations for all the examples and change the input parameters to see how each input parameter affects the simulation outcomes or design operating characteristics.
Taking a learning-by-doing approach, this tutorial-style book guides readers on planning and executing various types of adaptive designs. It helps them develop the skills to begin using the designs immediately.
(https://www.crcpress.com/Introductory-Adaptive-Trial-Designs-A-Practical-Guide-with-R/Chang/9781498717465)
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