| 000 -LEADER |
|---|
| fixed length control field |
04631cam a22002297a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
150909s2015 flua b 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781498717465 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
610.724 |
| Item number |
C4I6 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Chang, Mark |
| 9 (RLIN) |
328406 |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Introductory adaptive trial designs: a practical guide with R |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
Boca Raton, |
| Name of publisher, distributor, etc |
CRC Press |
| Date of publication, distribution, etc |
2015 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xiii, 218 p. |
| 440 ## - SERIES STATEMENT/ADDED ENTRY--TITLE |
|---|
| Title |
Chapman and Hall/CRC biostatistics series |
| 9 (RLIN) |
328412 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Table of Contents: <br/><br/>1. Introduction<br/><br/>Motivation<br/>Adaptive Designs in Clinical Trials<br/>Clinical Trial Simulation<br/>Characteristics of Adaptive Designs<br/>FAQs about Adaptive Designs<br/><br/>2. Classical Design<br/><br/><br/>Introduction<br/>Two-Group Superiority<br/>Two-Group Noninferiority Trial<br/>Two-Group Equivalence Trial<br/>Trial with Any Number of Groups<br/>Multigroup Dose-Finding Trial<br/>Summary and Discussion<br/><br/>3. Two-Stage Adaptive Confirmatory Design Method<br/><br/>General Formulation<br/>Method Based on Sum of p-Values<br/>Method with Product of p-Values<br/>Method with Inverse-Normal p-Values<br/>Comparisons of Adaptive Design Methods<br/><br/>4. K-Stage Adaptive Confirmatory Design Methods<br/><br/>Test Statistics<br/>Determination of Stopping Boundary<br/>Error-Spending Function<br/>Power and Sample Size<br/>Error Spending Approach<br/><br/>5. Sample-Size Reestimation Design<br/><br/>Sample Size Reestimation Methods<br/>Comparisons of SSR Methods<br/>K-Stage Sample Size Reestimaion Trial<br/>Summary<br/><br/>6. Special Two-Stage Group Sequential Trials<br/><br/>Event-Based Design<br/>Equivalence Trial<br/>Adaptive Design with Farrington-Manning Margin<br/>Noninferiority Trial with Paired Binary Data<br/>Trial with Incomplete Paired Data<br/>Trial with Coprimary Endpoints<br/>Trial with Multiple Endpoints<br/><br/>7. Pick-the-Winners Design<br/><br/>Overview of Multiple-Arm Designs<br/>Pick-the-Winner Design<br/>Stopping Boundary and Sample Size<br/>Summary and Discussion<br/><br/>8. The Add-Arms Design<br/><br/>Introduction<br/>The Add-Arm Design<br/>Clinical Trial Examples<br/>Extension of Add-Arms Designs<br/>Summary<br/><br/>9. Biomarker-Adaptive Design<br/><br/>Taxonomy<br/>Biomarker-Enrichment Design<br/>Biomarker-Informed Adaptive Design<br/>Summary<br/><br/>10. Response-Adaptive Randomization<br/><br/>Basic Response-Adaptive Randomizations<br/>Generalized Response-Adaptive Randomization<br/>Summary and Discussion<br/><br/>11. Adaptive Dose-Escalation Trial<br/><br/>Oncology Dose-Escalation Trial<br/>Continual Reassessment Method<br/>Alternative Form CRM<br/>Evaluation of Dose-Escalation Design<br/>Summary and Discussion<br/><br/>12. Deciding Which Adaptive Design to Use<br/><br/>Determining the Objectives<br/>Determining Design Parameters<br/>Evaluation Matrix of Adaptive Design<br/><br/>13. Monitoring Trials and Making Adaptations<br/><br/>Stopping and Arm-Selection<br/>Conditional Power<br/>Sample-Size Reestimation<br/>New Randomization Scheme<br/><br/>14. Data Analyses of Adaptive Trials<br/><br/>Orderings in Sample Space<br/>Adjusted p-Value<br/>Parameter Estimation<br/>Confidence Interval<br/>Summary<br/><br/>15. Planning and Execution<br/><br/>Study Planning<br/>Working with a Regulatory Agency<br/>Trial Execution<br/>Summary<br/><br/>Appendix A: Thirty-Minute Tutorial to R<br/><br/>Appendix B: R Functions for Adaptive Designs<br/><br/>Bibliography<br/><br/>Index<br/><br/><br/><br/> |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
All the Essentials to Start Using Adaptive Designs in No Time<br/><br/>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.<br/><br/>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.<br/><br/>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.<br/><br/><br/>(https://www.crcpress.com/Introductory-Adaptive-Trial-Designs-A-Practical-Guide-with-R/Chang/9781498717465)<br/> |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Clinical trials - Design |
| 9 (RLIN) |
328407 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Clinical trials - Computer simulation |
| 9 (RLIN) |
328408 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Clinical trials - Statistical methods |
| 9 (RLIN) |
328409 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Adaptive sampling (Statistics) |
| 9 (RLIN) |
328410 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
R (Computer program language) |
| 9 (RLIN) |
328411 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Item type |
Books |
