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BPrinStratTTE: Causal Effects in Principal Strata Defined by Antidrug Antibodies

CRAN status

Bayesian models to estimate causal effects of biological treatments on time-to-event endpoints in clinical trials with principal strata defined by the occurrence of antidrug antibodies.

Scope

Principal stratification methodology

References:

Bornkamp, B., Rufibach, K., Lin, J., Liu, Y., Mehrotra, D. V., Roychoudhury, S., Schmidli, H., Shentu, Y., and Wolbers, M. (2021), “Principal stratum strategy: Potential role in drug development,” Pharm Stat, 20, 737–751. https://doi.org/10.1002/pst.2104.

Frangakis, C. E., and Rubin, D. B. (2002), “Principal stratification in causal inference,” Biometrics, 58, 21–29. https://doi.org/10.1111/j.0006-341x.2002.00021.x.

Imbens, G. W., and Rubin, D. B. (1997), “Bayesian Inference for Causal Effects in Randomized Experiments with Noncompliance,” Ann Stat, 25, 305–327. https://doi.org/10.1214/aos/1034276631.

International Council for Harmonisation (ICH) (2020), “ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials.” https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf.

Lipkovich, I., Ratitch, B., Qu, Y., Zhang, X., Shan, M., and Mallinckrodt, C. (2022), “Using principal stratification in analysis of clinical trials,” Stat Med, 41, 3837–387. https://doi.org/10.1002/sim.9439.

Installation

The current stable version of the package can be installed from CRAN with:

install.packages("BPrinStratTTE")

The development version of the package can be installed from GitHub with:

if (!require("remotes")) {install.packages("remotes")}
remotes::install_github("Boehringer-Ingelheim/BPrinStratTTE")

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.