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seqDesign: Simulation and Group Sequential Monitoring of Randomized Two-Stage Treatment Efficacy Trials with Time-to-Event Endpoints

seqDesign is an R package implementing a modification of the preventive vaccine efficacy trial design of Gilbert P. B., Grove D. et al. (2011), A Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens, Statistical Communications in Infectious Diseases, 3:1, Article 4.

Check out the following two vignettes, in this order, for a brief introduction to the package:

  • Instructions for Using seqDesign and Generating the Output PDF Report, and
  • seqDesign's Report Template.

The latter includes a report template PDF as well as the underlying code (Latex + R included in an Rnw file).

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Install

install.packages('seqDesign')

Monthly Downloads

178

Version

1.2

License

GPL-2

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Last Published

May 22nd, 2019

Functions in seqDesign (1.2)

VEpowerPP

Unconditional Power to Detect Positive Treatment Efficacy in a Per-Protocol Cohort
rankTrial

Ranking and Selection, and Head-to-Head Comparison of Individual and Pooled Treatment Arms
simTrial

Simulation of Multi-Arm Randomized Phase IIb/III Efficacy Trials with Time-to-Event Endpoints
censTrial

Generation of Pre-Unblinded Follow-Up Data-Sets by Applying the Monitoring Outcomes
getBlockSize

Determine block size for use in blocked randomization
monitorTrial

Group Sequential Monitoring of Simulated Efficacy Trials for the Event of Potential Harm, Non-Efficacy, and High Efficacy