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Statistical Considerations in the Use of Composite Endpoints in Time to Event Analyses

In: Developments in Statistical Evaluation of Clinical Trials

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  • Richard J. Cook

    (University of Waterloo, Department of Statistics and Actuarial Science)

  • Ker-Ai Lee

    (University of Waterloo, Department of Statistics and Actuarial Science)

Abstract

Many disease processes are complex and impact functional ability and quality of life of affected individuals in a multitude of ways. Diseases such as diabetes, lupus and other autoimmune disorders, for example, involve several different organ systems, which makes it challenging to select one specific endpoint. In other settings a disease puts affected individuals at risk of several different types of undesirable clinical events. This is the case in cardiovascular disease where individuals are at increased risk of myocardial infarction, angina, or stroke. In such settings it is common for clinical trialists to adopt composite endpoints on which to base treatment comparisons. We discuss issues in the use of composite endpoints and emphasize the difficulty in interpreting measures of effect.

Suggested Citation

  • Richard J. Cook & Ker-Ai Lee, 2014. "Statistical Considerations in the Use of Composite Endpoints in Time to Event Analyses," Springer Books, in: Kees van Montfort & Johan Oud & Wendimagegn Ghidey (ed.), Developments in Statistical Evaluation of Clinical Trials, edition 127, chapter 0, pages 209-226, Springer.
    • Handle: RePEc:spr:sprchp:978-3-642-55345-5_12
    DOI: 10.1007/978-3-642-55345-5_12
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