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In Reply: In response to Drs van Leth and Lange, we do not wish to comment on the appropriateness or otherwise of surrogates in clinical trials in HIV, or the confounding of efficacy and tolerability measures discussed by them. However, time to treatment failure was one of the examples we used to describe a situation in which use of a composite outcome is appropriate, when there is a single underlying clinical occurrence (treatment failure) that can occur in multiple ways.

We disagree with van Leth and Lange that examination of the estimates across individual components of composite outcomes can be misleading. In fact, we believe just the opposite—that failure to do so is misleading. In support of their view, van Leth and Lange raise the issue of competing risks¹ where, for example, a subject who has died is no longer at risk of experiencing adverse effects. A composite outcome unduly . . . [Full Text of this Article]

Nick Freemantle, PhD; Melanie Calvert, PhD; John Wood, MSc; Joanne Eastaugh, PhD; Carl Griffin, MSc
Department of Primary Care and General Practice
University of Birmingham
Birmingham, England

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Use of Composite End Points to Measure Clinical Events
Frank van Leth and Joep M. A. Lange
JAMA. 2003;290(11):1456-1457.
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