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Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial

Inference on treatment effects from a randomized clinical trial in the presence of premature... The Superior Yield of the New Strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) was a randomized, open-label, multicenter clinical trial comparing 2 anticoagulant drugs on the basis of time-to-event endpoints. In contrast to other studies of these agents, the primary, intent-to-treat analysis did not find evidence of a difference, leading to speculation that premature discontinuation of the study agents by some subjects may have attenuated the apparent treatment effect and thus to interest in inference on the difference in survival distributions were all subjects in the population to follow the assigned regimens, with no discontinuation. Such inference is often attempted via ad hoc analyses that are not based on a formal definition of this treatment effect. We use SYNERGY as a context in which to describe how this effect may be conceptualized and to present a statistical framework in which it may be precisely identified, which leads naturally to inferential methods based on inverse probability weighting. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Biostatistics Oxford University Press

Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial

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References (23)

Publisher
Oxford University Press
Copyright
The Author 2010. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].
ISSN
1465-4644
eISSN
1468-4357
DOI
10.1093/biostatistics/kxq054
pmid
20797983
Publisher site
See Article on Publisher Site

Abstract

The Superior Yield of the New Strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) was a randomized, open-label, multicenter clinical trial comparing 2 anticoagulant drugs on the basis of time-to-event endpoints. In contrast to other studies of these agents, the primary, intent-to-treat analysis did not find evidence of a difference, leading to speculation that premature discontinuation of the study agents by some subjects may have attenuated the apparent treatment effect and thus to interest in inference on the difference in survival distributions were all subjects in the population to follow the assigned regimens, with no discontinuation. Such inference is often attempted via ad hoc analyses that are not based on a formal definition of this treatment effect. We use SYNERGY as a context in which to describe how this effect may be conceptualized and to present a statistical framework in which it may be precisely identified, which leads naturally to inferential methods based on inverse probability weighting.

Journal

Biostatistics – Oxford University Press

Published: Apr 25, 2011

Keywords: Dynamic treatment regime Inverse probability weighting Potential outcomes Proportional hazards model

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