# --------------------------------------------
# CITATION file created with {cffr} R package
# See also: https://docs.ropensci.org/cffr/
# --------------------------------------------
 
cff-version: 1.2.0
message: 'To cite package "monitOS" in publications use:'
type: software
license: MIT
title: 'monitOS: Monitoring Overall Survival in Pivotal Trials in Indolent Cancers'
version: 0.2.0
doi: 10.1080/19466315.2024.2365648
identifiers:
- type: doi
  value: 10.32614/CRAN.package.monitOS
abstract: '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.'
authors:
- family-names: Hampson
  given-names: Lisa
  email: lisa.hampson@novartis.com
- family-names: Coroller
  given-names: Thibaud
  email: thibaud.coroller@novartis.com
- family-names: Koukouli
  given-names: Evanthia
  email: evanthia.koukouli@novartis.com
preferred-citation:
  type: article
  title: Monitoring Overall Survival in Pivotal Trials in Indolent Cancers
  authors:
  - family-names: Fleming
    given-names: Thomas R.
  - family-names: Hampson
    given-names: Lisa V.
  - family-names: Bharani-Dharan
    given-names: Bharani
  - family-names: Bretz
    given-names: Frank
  - family-names: Chakravartty
    given-names: Arunava
  - family-names: Coroller
    given-names: Thibaud
    email: thibaud.coroller@novartis.com
  - family-names: Koukouli
    given-names: Evanthia
    email: evanthia.koukouli@novartis.com
  - family-names: Wittes
    given-names: Janet
  - family-names: Yateman
    given-names: Nigel
  - family-names: Zuber
    given-names: Emmanuel
  journal: Statistics in Biopharmaceutical Research
  year: '2025'
  volume: '17'
  issue: '2'
  doi: 10.1080/19466315.2024.2365648
  url: https://www.tandfonline.com/doi/full/10.1080/19466315.2024.2365648
  start: '161'
  end: '172'
repository: https://novartis.r-universe.dev
repository-code: https://github.com/Novartis/monitOS
commit: 7095b3f3d1676c041afc0138de8ec05ddbb95a11
url: https://opensource.nibr.com/monitOS/
date-released: '2026-04-15'
contact:
- family-names: Coroller
  given-names: Thibaud
  email: thibaud.coroller@novartis.com