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

seqDesign is a versatile R package implementing a spectrum of event-driven and fixed follow-up preventive vaccine efficacy trial designs including designs 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):1037.

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).