%\VignetteIndexEntry{Instructions for Using seqDesign and Generating the Output PDF Report} %\VignetteEngine{knitr::knitr} %\VignetteEncoding{UTF-8} \documentclass[11pt]{article} \usepackage{amsmath, amsthm, amssymb} \usepackage[cp1250]{inputenc} \usepackage[english]{babel} \usepackage{amsfonts} \usepackage{multirow} \usepackage[round,authoryear]{natbib} \usepackage{lscape} \usepackage{float} \usepackage{array} \usepackage{subfig} \usepackage{epsfig, psfrag, graphicx, lscape} \textwidth=6.5in \textheight=8.4in \setlength{\topmargin}{0.21truein} \hoffset-18mm \usepackage{parskip} \begin{document} \pagestyle{empty} \begin{center} {\LARGE \textbf{Instructions for Using `seqDesign' and Generating Output Tables and Figures Describing Operating Characteristics of the Trial Design}\bigskip\medskip\\ } \end{center} \vspace*{5mm} \textbf{Step 1.} Specify per-arm sample sizes in the placebo and vaccine arm, average VE scenarios (the length of each component of \verb+aveVElist+ equals the number of vaccine arms in a given scenario), the annual incidence in the placebo arm, the type of estimand, the logical value for whether lagged non-efficacy monitoring should be applied (and, if TRUE, the time lag in weeks for this monitoring), and the output directory: <>= N.pla <- 1900 N.vax <- 1700 aveVElist <- list(-2, -1.5, -1, -0.5, 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, c(0,0), c(0.4,0), c(0.4,0.4), c(0.4,0.2), c(0.4,0.3), c(0.5,0.3), c(0.5,0.4), c(0.6,0.3), c(0.6,0.4)) infRate <- 0.04 estimand <- "cuminc" laggedMonitoring <- TRUE lagTime <- 26 outDir <- "./" @ \textbf{Step 2.} Simulate data-sets (for each component of \verb+aveVElist+), apply the monitoring procedures, and extract results needed for generating output tables and figures: <>= for (i in 1:length(aveVElist)){ simTrial(N=c(N.pla, rep(N.vax, length(aveVElist[[i]]))), aveVE=c(0, aveVElist[[i]]), VEmodel="half", vePeriods=c(1,27,79), enrollPeriod=78, enrollPartial=13, enrollPartialRelRate=0.5, dropoutRate=0.05, infecRate=infRate, fuTime=156, visitSchedule=c(0, (13/3)*(1:4), seq(13*6/3, 156, by=13*2/3)), missVaccProb=c(0,0.05,0.1,0.15), VEcutoffWeek=26, nTrials=1000, blockSize=NULL, stage1=78, saveDir=outDir, randomSeed=9) monitorTrial(dataFile= paste0("simTrial_nPlac=",N.pla,"_nVacc=", paste(rep(N.vax, length(aveVElist[[i]])), collapse="_"), "_aveVE=",paste(aveVElist[[i]], collapse="_"),"_infRate=",infRate,".RData"), stage1=78, stage2=156, harmMonitorRange=c(10,100), alphaPerTest=NULL, nonEffStartMethod="FKG", nonEffInterval=20, lowerVEnoneff=0, upperVEnoneff=0.4, stage1VE=0, lowerVEuncPower=0, highVE=0.6, alphaNoneff=0.05, alphaStage1=0.05, alphaUncPower=0.05, alphaHigh=0.05, estimand=estimand, laggedMonitoring=laggedMonitoring, lagTime=lagTime, saveDir=outDir) censTrial(dataFile= paste0("simTrial_nPlac=",N.pla, "_nVacc=", paste(rep(N.vax, length(aveVElist[[i]])), collapse="_"),"_aveVE=", paste(aveVElist[[i]], collapse="_"),"_infRate=",infRate,".RData"), monitorFile= paste0("monitorTrial_nPlac=", N.pla, "_nVacc=", paste(rep(N.vax, length(aveVElist[[i]])), collapse="_"),"_aveVE=", paste(aveVElist[[i]], collapse="_"),"_infRate=",infRate,"_",estimand,".RData"), stage1=78, stage2=156, saveDir=outDir) if (i %in% 17:22){ rankTrial(censFile= paste0("trialDataCens_nPlac=",N.pla,"_nVacc=", paste(rep(N.vax, length(aveVElist[[i]])), collapse="_"),"_aveVE=", paste(aveVElist[[i]], collapse="_"),"_infRate=",infRate,"_",estimand,".RData"), idxHighestVE=1, headHead=matrix(1:2, nrow=1, ncol=2), lowerVE=0, stage1=78, stage2=156, alpha=0.05, saveDir=outDir) } } VEpowerPP(dataList= as.list(paste0("trialDataCens_nPlac=", N.pla, "_nVacc=", N.vax, "_aveVE=", do.call("c", aveVElist[5:13]), "_infRate=",infRate,"_",estimand,".RData")), lowerVEuncPower=0, alphaUncPower=0.05, VEcutoffWeek=26, stage1=78, outName=paste0("VEpwPP_nPlac=", N.pla, "_nVacc=", N.vax, "_infRate=",infRate,".RData"), saveDir=outDir) @ \textbf{Step 3.} Look up the vignette titled ``seqDesign's Report Template" by, e.g., calling <>= browseVignettes(package="seqDesign") @ The vignette's source contains .Rnw template code for generating the report, and the vignette's PDF is the compiled template code (note that it is a static PDF because the .Rnw source requires seqDesign's .RData output files to be compiled and those are not part of the package, the user generates them in Step~2). Update the user-specified constants in the first R chunk and compile the PDF report. Note that other changes in table/figure captions, legends and labels might be needed to reflect the specified trial design. \end{document}