Planning and Analyzing Clinical Trials with Composite Endpoints

Planning and Analyzing Clinical Trials with Composite Endpoints

Kieser, Meinhard; Rauch, Geraldine; Schueler, Svenja

Springer International Publishing AG

05/2018

255

Dura

Inglês

9783319737690

15 a 20 dias

576

Descrição não disponível.

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.

Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.

62L05, 62P10;composite endpoints;clinical trials;sample size calculation;sequential designs;multiple testing;survival analysis;competing risks