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

Publication ,  Journal Article
Zhang, M; Tsiatis, AA; Davidian, M; Pieper, KS; Mahaffey, KW
Published in: Biostatistics
April 2011

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.

Duke Scholars

Published In

Biostatistics

DOI

EISSN

1468-4357

Publication Date

April 2011

Volume

12

Issue

2

Start / End Page

258 / 269

Location

England

Related Subject Headings

  • Withholding Treatment
  • Treatment Outcome
  • Survival Analysis
  • Statistics & Probability
  • Randomized Controlled Trials as Topic
  • Proportional Hazards Models
  • Probability
  • Multicenter Studies as Topic
  • Mortality
  • Monte Carlo Method
 

Citation

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Zhang, M., Tsiatis, A. A., Davidian, M., Pieper, K. S., & Mahaffey, K. W. (2011). Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial. Biostatistics, 12(2), 258–269. https://doi.org/10.1093/biostatistics/kxq054
Zhang, Min, Anastasios A. Tsiatis, Marie Davidian, Karen S. Pieper, and Kenneth W. Mahaffey. “Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial.Biostatistics 12, no. 2 (April 2011): 258–69. https://doi.org/10.1093/biostatistics/kxq054.
Zhang M, Tsiatis AA, Davidian M, Pieper KS, Mahaffey KW. Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial. Biostatistics. 2011 Apr;12(2):258–69.
Zhang, Min, et al. “Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial.Biostatistics, vol. 12, no. 2, Apr. 2011, pp. 258–69. Pubmed, doi:10.1093/biostatistics/kxq054.
Zhang M, Tsiatis AA, Davidian M, Pieper KS, Mahaffey KW. Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial. Biostatistics. 2011 Apr;12(2):258–269.
Journal cover image

Published In

Biostatistics

DOI

EISSN

1468-4357

Publication Date

April 2011

Volume

12

Issue

2

Start / End Page

258 / 269

Location

England

Related Subject Headings

  • Withholding Treatment
  • Treatment Outcome
  • Survival Analysis
  • Statistics & Probability
  • Randomized Controlled Trials as Topic
  • Proportional Hazards Models
  • Probability
  • Multicenter Studies as Topic
  • Mortality
  • Monte Carlo Method