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Implements estimation and testing procedures for evaluating an intermediate biomarker response as a principal surrogate of a clinical response to treatment (i.e., principal stratification effect modification analysis), as described in Juraska M, Huang Y, and Gilbert PB (2020), Inference on treatment effect modification by biomarker response in a three-phase sampling design, Biostatistics, 21(3): 545-560 <doi:10.1093/biostatistics/kxy074>. The methods avoid the restrictive 'placebo structural risk' modeling assumption common to past methods and further improve robustness by the use of nonparametric kernel smoothing for biomarker density estimation. A randomized controlled two-group clinical efficacy trial is assumed with an ordered categorical or continuous univariate biomarker response measured at a fixed timepoint post-randomization and with a univariate baseline surrogate measure allowed to be observed in only a subset of trial participants with an observed biomarker response (see the flexible three-phase sampling design in the paper for details). Bootstrap-based procedures are available for pointwise and simultaneous confidence intervals and testing of four relevant hypotheses. Summary and plotting functions are provided for estimation results.
| Version: | 1.0.3 |
| Imports: | graphics, stats, osDesign, np, chngpt, MASS |
| Suggests: | knitr, rmarkdown |
| Published: | 2020-11-18 |
| DOI: | 10.32614/CRAN.package.pssmooth |
| Author: | Michal Juraska [aut, cre] |
| Maintainer: | Michal Juraska <mjuraska at fredhutch.org> |
| BugReports: | https://github.com/mjuraska/pssmooth/issues |
| License: | GPL-2 |
| URL: | https://github.com/mjuraska/pssmooth |
| NeedsCompilation: | no |
| Citation: | pssmooth citation info |
| Materials: | README NEWS |
| CRAN checks: | pssmooth results |
| Reference manual: | pssmooth.pdf |
| Package source: | pssmooth_1.0.3.tar.gz |
| Windows binaries: | r-devel: pssmooth_1.0.3.zip, r-release: pssmooth_1.0.3.zip, r-oldrel: pssmooth_1.0.3.zip |
| macOS binaries: | r-release (arm64): pssmooth_1.0.3.tgz, r-oldrel (arm64): pssmooth_1.0.3.tgz, r-release (x86_64): pssmooth_1.0.3.tgz, r-oldrel (x86_64): pssmooth_1.0.3.tgz |
| Old sources: | pssmooth archive |
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These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.