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Planning and Analyzing Clinical Trials with Composite Endpoints

Planning and Analyzing Clinical Trials with Composite Endpoints

Hardcover

Series: Springer Pharmaceutical Statistics

Medical ReferenceGeneral Science

ISBN10: 3319737694
ISBN13: 9783319737690
Publisher: Springer Nature
Published: May 31 2018
Pages: 255
Weight: 1.23
Height: 0.63 Width: 6.14 Depth: 9.21
Language: English
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.

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