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.