Sensitivity analysis in non-inferiority trials with residual inconstancy after covariate adjustment Public Deposited

http://ir.library.oregonstate.edu/concern/articles/n009w398c

To the best of our knowledge, one or more authors of this paper were federal employees when contributing to this work. This is the publisher’s final pdf. The article is copyrighted by the Royal Statistical Society and published by John Wiley & Sons Ltd. It can be found at:  http://onlinelibrary.wiley.com/journal/10.1111/%28ISSN%291467-9876.

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  • A major issue in non-inferiority trials is the controversial assumption of constancy, namely that the active control has the same effect relative to placebo as in previous studies comparing the active control with placebo. The constancy assumption is often in doubt, which has motivated various methods that ‘discount’ the control effect estimate from historical data as well as methods that adjust for imbalances in observed covariates. We develop a new approach to deal with residual inconstancy, i.e. possible violations of the constancy assumption due to imbalances in unmeasured covariates after adjusting for the measured covariates. We characterize the extent of residual inconstancy under a generalized linear model framework and use the results to obtain fully adjusted estimates of the control effect in the current study based on plausible assumptions about an unmeasured covariate. Because such assumptions may be difficult to justify, we propose a sensitivity analysis approach that covers a range of situations. This approach is developed for indirect comparison with placebo and effect retention, and implemented through additive and multiplicative adjustments.The approach proposed is applied to two examples concerning benign prostate hyperplasia and human immunodeficiency virus infection, and evaluated in simulation studies.
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  • Zhang, Z., Nie, L., Soon, G. and Zhang, B. (2014). Sensitivity analysis in non-inferiority trials with residual inconstancy after covariate adjustment. Journal of the Royal Statistical Society: Series C (Applied Statistics), 63: 515–538. doi:10.1111/rssc.12050
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  • description.provenance : Approved for entry into archive by Erin Clark(erin.clark@oregonstate.edu) on 2014-10-24T15:32:59Z (GMT) No. of bitstreams: 2 ZhangBoPHHSSensitivityAnalysisNon-Inferiority.pdf: 1039869 bytes, checksum: f55a8db2318f83f11dadeaa4ab26de9d (MD5) ZhangBoPHHSSensitivityAnalysisNon-Inferiority_SupportingInformation.pdf: 50832 bytes, checksum: 7f98ca15d7cb82bb3040f24966fdd58a (MD5)
  • description.provenance : Made available in DSpace on 2014-10-24T15:32:59Z (GMT). No. of bitstreams: 2 ZhangBoPHHSSensitivityAnalysisNon-Inferiority.pdf: 1039869 bytes, checksum: f55a8db2318f83f11dadeaa4ab26de9d (MD5) ZhangBoPHHSSensitivityAnalysisNon-Inferiority_SupportingInformation.pdf: 50832 bytes, checksum: 7f98ca15d7cb82bb3040f24966fdd58a (MD5) Previous issue date: 2014-08
  • description.provenance : Submitted by Erin Clark (erin.clark@oregonstate.edu) on 2014-10-24T15:32:27Z No. of bitstreams: 2 ZhangBoPHHSSensitivityAnalysisNon-Inferiority.pdf: 1039869 bytes, checksum: f55a8db2318f83f11dadeaa4ab26de9d (MD5) ZhangBoPHHSSensitivityAnalysisNon-Inferiority_SupportingInformation.pdf: 50832 bytes, checksum: 7f98ca15d7cb82bb3040f24966fdd58a (MD5)

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