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# CITATION file created with {cffr} R package
# See also: https://docs.ropensci.org/cffr/
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cff-version: 1.2.0
message: 'To cite package "seqDesign" in publications use:'
type: software
license: GPL-2.0-only
title: 'seqDesign: Simulation and Group-Sequential Monitoring of Randomized Treatment
  Efficacy Trials with Time-to-Event Endpoints'
version: '1.3'
doi: 10.32614/CRAN.package.seqDesign
abstract: 'A broad spectrum of both event-driven and fixed follow-up preventive vaccine
  efficacy trial designs, including designs of Gilbert, Grove et al. (2011, Statistical
  Communications in Infectious Diseases), are implemented, with application generally
  to individual-randomized clinical trials with multiple active treatment groups and
  a shared control group, and a study endpoint that is a time-to-event endpoint subject
  to right-censoring. The design accommodates the following features: (1) the possibility
  that the efficacy of the treatment/vaccine groups may take time to accrue while
  the multiple treatment administrations/vaccinations are given, (2) hazard ratio
  and cumulative incidence-based treatment/vaccine efficacy parameters and multiple
  estimation/hypothesis testing procedures are available, (3) interim/group-sequential
  monitoring of each treatment group for potential harm, non-efficacy (lack of benefit),
  efficacy (benefit), and high efficacy, (3) arbitrary alpha spending functions for
  different monitoring outcomes, (4) arbitrary timing of interim looks, separate for
  each monitoring outcome, in terms of either event accrual or calendar time, (5)
  flexible analysis cohort characterization (intention-to-treat vs. per-protocol/as-treated;
  counting only events for analysis that occur after a specific point in study time),
  and (6) division of the trial into two stages of time periods where each treatment
  is first evaluated for efficacy in the first stage of follow-up, and, if and only
  if it shows significant treatment efficacy in stage one, it is evaluated for longer-term
  durability of efficacy in stage two. The package produces plots and tables describing
  operating characteristics of a specified design including a description of monitoring
  boundaries on multiple scales for the different outcomes; event accrual since trial
  initiation; probabilities of stopping early for potential harm, non-efficacy, etc.;
  an unconditional power for intention-to-treat and per-protocol analyses; calendar
  time to crossing a monitoring boundary or reaching the target number of endpoints
  if no boundary is crossed; trial duration; unconditional power for comparing treatment
  efficacies; and the distribution of the number of endpoints within an arbitrary
  study time interval (e.g., events occurring after the treatments/vaccinations are
  given), useful as input parameters for the design of studies of the association
  of biomarkers with a clinical outcome (surrogate endpoint problem). The code can
  be used for a single active treatment versus control design and for a single-stage
  design.'
authors:
- family-names: Juraska
  given-names: Michal
  email: mjuraska@fredhutch.org
- family-names: Grove
  given-names: Doug
  email: dgrove@scharp.org
repository: https://mjuraska.r-universe.dev
repository-code: https://github.com/mjuraska/seqDesign
commit: 23965224e807e5512f3a6c75c008ab02f490e9e5
url: https://github.com/mjuraska/seqDesign
date-released: '2020-08-13'
contact:
- family-names: Juraska
  given-names: Michal
  email: mjuraska@fredhutch.org