precautionary

precautionary implements new layers of patient-centered safety analysis for phase 1 dose-escalation trials, adding diagnostics to examine the safety characteristics of these designs in light of expected inter-individual variation in pharmacokinetics and pharmacodynamics. See Norris (2020b), "Retrospective analysis of a fatal dose-finding trial" arXiv:2004.12755 and (2020c) "What Were They Thinking? Pharmacologic priors implicit in a choice of 3+3 dose-escalation design" arXiv:2012.05301.

Installation

Releases starting with 0.2.3 incorporate fast numerics implemented in Rust, a modern programming language that emphasizes performance and reliability---attributes crucial to applications such as the analysis of clinical trials.

These innovations have delayed review and acceptance by CRAN, pending which the newest features of precautionary will be available only here on GitHub.

# Install release version from GitHub
remotes::install_github("dcnorris/precautionary")

# Install obsolete version from CRAN (where review of new Rust library remains pending)
install.package("precautionary")

To date, those features of precautionary which depend on the Prolog code in exec/prolog/ have been prebuilt into the package, for example as the arrays T[,,,] written into R/sysdata.rda by exec/make_sysdata_TUb.R. Methodologists who wish to examine, recompute and verify these arrays are advised to install Scryer Prolog.

It is a near-term goal for precautionary to reveal more transparently Prolog's special contributions to its analysis of dose-escalation designs.

Usage

Please see the vignettes under the Articles tab above.

References

The precautionary package is the pointy end of the spear in a larger DTAT research programme, of which the following are key outputs. Several of these citations have accompanying online resources such as web applications. For the key references, lay explanations are available.