عنوان

Planning and analyzing clinical trials with composite endpoints /

3319737694

3319737708

9783319737690

9783319737706

9783319737690

Planning and analyzing clinical trials with composite endpoints /

[Book]

Geraldine Rauch, Svenja Schüler, Meinhard Kieser.

Cham, Switzerland :

Springer,

[2017]

1 online resource

Springer series in pharmaceutical statistics

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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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, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes required for fast and easy implementation are provided. The book also discusses all the methods in the context of relevant guidelines related to the topic. To benefit most from the book, readers should be familiar with the principles of clinical trials and basic statistical methods.

Springer Nature

com.springer.onix.9783319737706

9783319737690

Clinical trials-- Statistical methods.

Clinical trials-- Statistical methods.

HEALTH & FITNESS-- Holism.

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Pharmaceutical technology.

Probability & statistics.

HEA-- 012000

HEA-- 020000

MED-- 004000

MED-- 029000

MED-- 040000

MED-- 092000

MED-- 101000

MED-- 109000

Rauch, Geraldine

Kieser, Meinhard

Schüler, Svenja

20200823104432.0

pn

[Book]

Y