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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Zhang, M; Tsiatis, AA; Davidian, M; Pieper, KS; Mahaffey, KW

Published Date

  • April 2011

Published In

Volume / Issue

  • 12 / 2

Start / End Page

  • 258 - 269

PubMed ID

  • 20797983

Pubmed Central ID

  • 20797983

Electronic International Standard Serial Number (EISSN)

  • 1468-4357

Digital Object Identifier (DOI)

  • 10.1093/biostatistics/kxq054

Language

  • eng

Conference Location

  • England