Package: monitOS Title: Monitoring Overall Survival in Pivotal Trials in Indolent Cancers URL: https://opensource.nibr.com/monitOS/, https://github.com/Novartis/monitOS BugReports: https://github.com/Novartis/monitOS/issues Version: 0.2.0 Authors@R: c( person("Thomas", "Fleming", email = "fleming@seattlebiostat.com", role ="ctb"), person("Lisa", "Hampson", email = "lisa.hampson@novartis.com", role ="aut"), person("Bharani", "Bharani-Dharan", email = "bharani.bharani-dharan@novartis.com", role ="ctb"), person("Frank", "Bretz", email = "frank.bretz@novartis.com", role = "ctb"), person("Arunava", "Chakravartty", email = "arunava.chakravartty@novartis.com", role = "ctb"), person("Thibaud", "Coroller", email = "thibaud.coroller@novartis.com", role = c("aut", "cre")), person("Evanthia", "Koukouli", email = "evanthia.koukouli@novartis.com", role = "aut"), person("Janet", "Wittes", email = "janet@wittesllc.com", role = "ctb"), person("Nigel", "Yateman", email = "nigel.yateman@novartis.com", role = "ctb"), person("Emmanuel", "Zuber", email = "emmanuel.zuber@novartis.com", role = "ctb"), person("Novartis", "Pharma AG", role = "cph") ) Description: These guidelines are meant to provide a pragmatic, yet rigorous, help to drug developers and decision makers, since they are shaped by three fundamental ingredients: the clinically determined margin of detriment on OS that is unacceptably high (delta null); the benefit on OS that is plausible given the mechanism of action of the novel intervention (delta alt); and the quantity of information (i.e. survival events) it is feasible to accrue given the clinical and drug development setting. The proposed guidelines facilitate transparent discussions between stakeholders focusing on the risks of erroneous decisions and what might be an acceptable trade-off between power and the false positive error rate. License: MIT + file LICENSE Maintainer: Thibaud Coroller Encoding: UTF-8 Roxygen: list(markdown = TRUE) RoxygenNote: 7.3.2 Imports: bslib, stats, glue, shiny, Suggests: testthat (>= 3.0.0), knitr, rmarkdown, pkgdown, shinylive VignetteBuilder: knitr Language: en-US Config/pak/sysreqs: cmake make libuv1-dev zlib1g-dev Repository: https://novartis.r-universe.dev Date/Publication: 2026-04-15 19:17:12 UTC RemoteUrl: https://github.com/novartis/monitos RemoteRef: HEAD RemoteSha: 7095b3f3d1676c041afc0138de8ec05ddbb95a11 NeedsCompilation: no Packaged: 2026-06-14 08:15:20 UTC; root Author: Thomas Fleming [ctb], Lisa Hampson [aut], Bharani Bharani-Dharan [ctb], Frank Bretz [ctb], Arunava Chakravartty [ctb], Thibaud Coroller [aut, cre], Evanthia Koukouli [aut], Janet Wittes [ctb], Nigel Yateman [ctb], Emmanuel Zuber [ctb], Novartis Pharma AG [cph]