| Description |
1 online resource (274 p.) |
| Series |
Chapman and Hall/CRC Biostatistics Ser |
|
Chapman and Hall/CRC Biostatistics Ser
|
| Contents |
Cover -- Half Title -- Series Page -- Title Page -- Copyright Page -- Contents -- Preface -- 1. Introduction of Single-Arm Phase II Trial Design -- 1.1. Why a Single-Arm Phase II Trial? -- 1.2. Primary Endpoint of a Single-Arm Phase II Trial -- 1.3. Hypothesis of a Single-Arm Phase II Trial -- 1.4. Test Statistic and Study Design -- 1.5. Choice of Alpha and Beta -- 1.6. Time-to-Event Endpoints -- 1.7. Literature Review -- 1.8. Scope and Motivation -- 2. Phase II Trial Design under Parametric Model -- 2.1. Introduction -- 2.2. Weibull Model -- 2.3. Log Transformed MLE Test |
|
2.4. Quadratic Transformed MLE Test -- 2.5. Sample Size Calculation -- 2.6. Accrual Duration Calculation -- 2.7. Comparison -- 2.8. Study Design and Data Analysis -- 2.9. R Code -- 3. One-Stage Design Evaluating Survival Probabilities -- 3.1. Introduction -- 3.2. Nelson-Aalen Estimate Based Tests -- 3.2.1. Test Statistics -- 3.2.2. Sample Size Formula -- 3.2.3. Sample Size Calculation -- 3.2.4. Comparison -- 3.3. Kaplan-Meier Estimate Based Tests -- 3.3.1. Test Statistics -- 3.3.2. Comparison -- 3.3.3. Study Design and Data Analysis -- 3.4. Test Median Survival Time -- 3.4.1. Test Statistics |
|
3.4.2. Sample Size Formula -- 4. Two-Stage Design Evaluating Survival Probabilities -- 4.1. Introduction -- 4.2. Two-Stage Design Based on Log-Log Test -- 4.2.1. Test Statistics -- 4.2.2. Optimal Two-Stage Design -- 4.2.3. Optimization Algorithm -- 4.2.4. Two-Stage Trial Data -- 4.2.5. Simulation -- 4.2.6. Study Design and Data Analysis -- 4.2.7. R Code for Two-Stage Design -- 4.3. Two-Stage Design Based on Arcsin-Square Root Test -- 4.3.1. Test Statistics -- 4.3.2. Optimal Two-Stage Design -- 4.3.3. Study Design and R Code -- 4.3.4. Simulation |
|
5. One-Stage Design Evaluating Survival Distributions -- 5.1. Introduction -- 5.2. One-Sample Log-Rank Test -- 5.2.1. Test Statistics -- 5.2.2. Sample Size Formula -- 5.2.3. Accrual Duration Calculation -- 5.2.4. Simulation -- 5.3. Modified One-Sample Log-Rank Test -- 5.3.1. Test Statistics -- 5.3.2. Sample Size Formula -- 5.3.3. Comparison -- 5.3.4. Sample Size vs. Length of Follow-up -- 5.3.5. R Code -- 5.4. Transformed OSLRT under PH Model -- 5.4.1. Transformed OSLRT -- 5.4.2. Number of Events Formulae -- 5.4.3. Comparison and R Code -- 5.5. General Hypothesis Testing -- 5.5.1. Test Statistics |
|
5.5.2. Sample Size Formula -- 5.5.3. Simulation -- 6. Two-Stage Design Evaluating Survival Distributions -- 6.1. Introduction -- 6.2. Two-Stage Design Using OSLRT with Full Follow-up -- 6.2.1. Two-Stage Test Statistics -- 6.2.2. Optimal Two-Stage Procedure -- 6.2.3. R Code for Two-Stage Design -- 6.2.4. Simulation -- 6.3. Two-Stage Design with Restricted Follow-up -- 6.3.1. Two-Stage Test Statistics -- 6.3.2. Optimal Two-Stage Procedure -- 6.3.3. R Code for Two-Stage Design with Restricted Follow-up -- 6.3.4. Simulation -- 7. Phase II Immunotherapy Trial Design -- 7.1. Introduction |
| Notes |
Description based upon print version of record |
|
7.2. Weighted Modi ed One-Sample Log-Rank Test |
| Subject |
Drugs -- Testing.
|
|
Drugs -- Testing
|
| Form |
Electronic book
|
| ISBN |
9781000421736 |
|
1000421732 |
|
9781000422481 |
|
1000422488 |
|
9781003129059 |
|
1003129056 |
|
