Planning and Analyzing Clinical Trials with Composite Endpoints
This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularl...
| Main Authors: | , , |
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| Corporate Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Cham :
Springer International Publishing : Imprint: Springer,
2017.
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| Edition: | 1st ed. 2017. |
| Series: | Springer Series in Pharmaceutical Statistics,
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| Subjects: | |
| Online Access: | Full Text via HEAL-Link |
Table of Contents:
- Preface
- Contents
- Part I General Introduction to Composite Endpoints
- 1 Definition and Rationale
- 2 Challenges of Composite Endpoints
- 3 Guideline View - Recommendations and Requirements
- 4 Clinical Trial Examples
- Part II Confirmatory Test Problem for a Single (Composite) Endpoint
- 5 The Single-Stage Design
- 6 Group-Sequential and Adaptive Designs
- 7 Related Software Code
- Part III Confirmatory Multiple Test Problem
- 8 Correlation Between Test Statistics
- 9 The Single-Stage Design
- 10 Group-Sequential and Adaptive Designs
- 11 Related Software Code
- Part IV Confirmatory Test Problem for a Weighted Composite Endpoint
- 12 Weighted Binary Composite Endpoint
- Weighted Time-to-Event Composite Endpoint
- 14 OtherWeighted Effect Measures
- 15 Related Software Code
- Part V Descriptive and Confirmatory Evaluation of the Components
- 16 Descriptive Analysis of the Components
- 17 Supplementary Confirmatory Analyses of the Components
- 18 Related Software Code
- Part VI Illustrating Clinical Trial Examples
- 19 Clinical Trial Examples with Binary (Composite) Endpoints
- 20 Clinical Trial Examples with (Composite) Time-to-Event Endpoints.
