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CRC handbook of sample size guidelines for clinical trials

Author: Jonathan J Shuster
Publisher: Roca Raton, FL : CRC Press, Taylor & Francis Group, 2018. ©1990
Series: CRC revivals.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Shuster, Jonathan J., 1943-
CRC handbook of sample size guidelines for clinical trials.
Boca Raton : CRC Press, ©1990
(DLC) 89017267
(OCoLC)187400816
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Jonathan J Shuster
ISBN: 9781351366250 1351366254
OCLC Number: 1081315444
Description: 1 online resource (854 pages)
Contents: Cover; Title Page; Copyright Page; PREFACE; THE AUTHOR; Table of Contents; Chapter 1: HOW TO USE THE SAMPLE SIZE TABLES; 1.1. Identification of Parameters; References; Chapter 2: DESIGN AND ANALYSIS OF RANDOMIZED CLINICAL TRIALS; 2.1. Formulation of the Therapeutic Question; 2.1.1 One Sided vs. Two-Sided Question; 2.2. Design of the Clinical Trial; 2.2.1. Statistical Considerations; 2.3. Conduct of the Trial; 2.4. Analysis and Reporting of the Trial; 2.4.1. Crucial Elements; 2.4.2. Binomial Comparison; 2.4.2.1. Large Sample Methodology; 2.4.2.2. Confidence Intervals 2.4.2.3. Numerical Example (Test)2.4.2.4. Numerical Example (One-Sided Confidence Interval); 2.4.2.5. Numerical Example (Two-Sided Confidence Interval); 2.4.2.6. Small Sample Methodology; 2.4.3 Kaplan-Meier Comparison (Large Sample); 2.4.3.1. Assumptions Underlying Kaplan-Meier Curve; 2.4.3.2. Calculation of the Kaplan-Meier Curve; 2.4.3.3. Numerical Example; 2.4.3.4. Standard Error; 2.4.3.5. The Kaplan-Meier Comparison of Two Treatments; 2.4.3.6. Confidence Intervals for Difference in Fixed-Term Survival; 2.4.4. Logrank Test; 2.4.4.1. Important Observations With Respect to the Logrank Test 2.4.4.2. Numerical Example2.4.4.3. Footnotes to Numerical Example and the Logrank Test; 2.4.4.4. Proportional Hazards and the Logrank Test; References; Chapter 3: DERIVATION OF THE STATISTICAL RESULTS; 3.1. Derivation of the Large Sample Distribution of the Logrank Statistic; 3.2. Derivation of the Large Sample Distribution of the Kaplan-Meier Statistic; 3.2.1. Difference Between Kaplan-Meier Curves; 3.3. Exponential Survival; 3.4. Application of the Logrank Test When Survival is Exponential; 3.5. Exponential Survival with a Poisson Accrual Process; 3.6. Extension to the Two-Sample Problem 3.7. Exponential Survival with "Up-Front" Accrual3.8. Proportional Hazard Models and the Exponential Distribution; 3.9. Consideration in Planning a Trial Under Proportional Hazards: Putting It All Together; 3.10. Losses to Follow-Up and Sample Size Adjustment; 3.11. Interpretation of the Tables; 3.12. Multi-Treatment Trials; 3.12.1. Type A; 3.12.2. Type B; 3.12.3. Type C; 3.12.4. Type D; 3.13. Stratified Logrank Test; 3.13.1. Advice on Stratification 3.14. Intuitive Justification Why the Logrank Test and Kaplan-Meier Estimation for Actual Accrual Process Behave in the Limit in the Same Way as the Fixed Binomial Assumption3.15. Alternate Standard Error For the Kaplan-Meier Estimator; 3.16. Connection Between Kaplan-Meier With Binomial; References; FIGURES; 1. Codes for Tables; 2. Worksheet for Sample Size Determination; 3. Modifications of Figure 2; 4. Simple Randomization for 1200 Patients; 5. Random Length Permuted Blocks of Four or Six Patients; 6. One-Sided P-Values for Normal Curves; 7. Two-Sided P-Values for Normal Curves
Series Title: CRC revivals.
Other Titles: Handbook of sample size guidelines for clinical trials
Responsibility: author, Jonathan J. Shuster.

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