{ "_id": "6ae196ac3d0f299392dce602", "Package": "bbssr", "Type": "Package", "Title": "Blinded Sample Size Re-Estimation for Binary Endpoints", "Version": "3.0.0", "Authors@R": "person(\"Gosuke\", \"Homma\", email = \"my.name.is.gosuke@gmail.com\", \nrole = c(\"aut\", \"cre\"))", "Description": "Tools for blinded sample size re-estimation (BSSR) in\ntwo-arm clinical trials with binary endpoints, together with\nthe exact power and sample size calculations that the\nre-estimation relies on, for two independent groups, for\nmatched pairs and for stratified designs. For two independent\ngroups seven statistical tests are implemented: Pearson\nchi-squared, Fisher exact, Fisher mid-p, Z-pooled exact\nunconditional, the exact unconditional test of Boschloo (1970)\n, and the tests of\nnon-inferiority and equivalence of Blackwelder (1982)\n and of Farrington and\nManning (1990) , with a margin on\nthe scale of the risk difference or the risk ratio. Each test\nis available with a one-sided or a two-sided alternative, and\nthe exact unconditional tests can be combined with the\nBerger-Boos procedure. For matched pairs the McNemar tests and\nthe score test of Nam (1997) are\nimplemented, and for stratified designs the\nCochran-Mantel-Haenszel test, Cochran's test with the sample\nsize formulas of Woolson et al. (1986) \nand Nam (1992) , and the stratified exact\nconditional test of Jung (2014) .\nThe power, the distribution of the final sample size and the\ntype I error rate of a re-estimation design are computed\nexactly, by simulation for three or more strata and as averages\nover simulated allocation sequences for random stratum and\ngroup sizes, the significance level can be adjusted so that the\ntype I error rate is controlled, and the sample size can be\nre-estimated from the blinded data of a trial that is under\nway. Statistical methods based on Mehrotra et al. (2003)\n, Berger and Boos (1994)\n, Friede and Kieser (2004)\n, Friede et al. (2007)\n and Kieser (2020)\n.", "License": "MIT + file LICENSE", "URL": "https://gosukehommaex.github.io/bbssr/,\nhttps://github.com/gosukehommaEX/bbssr", "BugReports": "https://github.com/gosukehommaEX/bbssr/issues", "VignetteBuilder": "knitr", "Encoding": "UTF-8", "Language": "en-GB", "Roxygen": "list(markdown = TRUE)", "Config/testthat/edition": "3", "Config/roxygen2/version": "8.0.0", "Repository": "https://gosukehommaex.r-universe.dev", "Date/Publication": "2026-10-28 00:26:39 UTC", "RemoteUrl": "https://github.com/gosukehommaex/bbssr", "RemoteRef": "HEAD", "RemoteSha": "976931545a22d5628200e12f7584c3f1d7d8c875", "NeedsCompilation": "yes", "Packaged": { "Date": "2026-10-28 06:09:57 UTC", "User": "root" }, "Author": "Gosuke Homma [aut, cre]", "Maintainer": "Gosuke Homma ", "_user": "gosukehommaex", "_type": "src", "_file": "bbssr_3.0.0.tar.gz", "_fileid": "https://r2.ropensci.org/d4944a33d168cdb3978c9bd7bb186fded56e3cf027c099e723736270f5e6cf9a", "_filesize": 5335463, "_sha256": "d4944a33d168cdb3978c9bd7bb186fded56e3cf027c099e723736270f5e6cf9a", "_expires": "2027-02-05T06:20:30.000Z", "_created": "2026-10-28T06:09:57.000Z", "_published": "2026-10-28T06:31:08.066Z", "_upstream": "https://github.com/gosukehommaex/bbssr", "_status": "success", "_maintainer": { "name": "Gosuke Homma", "email": "my.name.is.gosuke@gmail.com", "login": "gosukehommaex", "description": "Biostatistician in a statistical methodology group at a pharmaceutical company. Dagashi (traditional Japanese snacks) enthusiast.", "uuid": 210875127 }, "_jobs": [ { "job": 122663000152, "time": 200, "config": "linux-devel-arm64", "r": "4.7.0", "check": "OK", "artifact": "12796093560" }, { "job": 122663000164, "time": 237, "config": "linux-devel-x86_64", "r": "4.7.0", "check": "OK", "artifact": "12795428741" }, { "job": 122663000124, "time": 197, "config": "linux-release-arm64", "r": "4.6.1", "check": "OK", "artifact": "12795509941" }, { "job": 122663000122, "time": 257, "config": "linux-release-x86_64", "r": "4.6.1", "check": "OK", "artifact": "12796530468" }, { "job": 122663000215, "time": 219, "config": "macos-oldrel-arm64", "r": "4.5.3", "check": "OK", "artifact": "12796456422" }, { "job": 122663000127, "time": 322, "config": "macos-oldrel-x86_64", "r": "4.5.3", "check": "OK", "artifact": "12796580223" }, { "job": 122663000158, "time": 497, "config": "macos-release-arm64", "r": "4.6.1", "check": "OK", "artifact": "12796760284" }, { "job": 122663000193, "time": 475, "config": "macos-release-x86_64", "r": "4.6.1", "check": "OK", "artifact": "12796785470" }, { "job": 122661259004, "time": 324, "config": "source", "r": "4.6.1", "check": "OK", "artifact": "12796117881" }, { "job": 122663000113, "time": 127, "config": "wasm-release", "r": "4.6.0", "check": "OK", "artifact": "12795399768" }, { "job": 122663000129, "time": 330, "config": "windows-devel-arm64", "r": "4.7.0", "check": "OK", "artifact": "12795734764" }, { "job": 122663000192, "time": 267, "config": "windows-devel-x86_64", "r": "4.7.0", "check": "OK", "artifact": "12795699655" }, { "job": 122663000181, "time": 212, "config": "windows-oldrel-x86_64", "r": "4.5.3", "check": "OK", "artifact": "12796340952" }, { "job": 122663000099, "time": 329, "config": "windows-release-arm64", "r": "4.6.1", "check": "OK", "artifact": "12796161991" }, { "job": 122663000123, "time": 206, "config": "windows-release-x86_64", "r": "4.6.1", "check": "OK", "artifact": "12795533387" } ], "_buildurl": "https://github.com/r-universe/gosukehommaex/actions/runs/40641728124", "_commit": { "id": "976931545a22d5628200e12f7584c3f1d7d8c875", "author": "Gosuke Homma ", "committer": "Gosuke Homma ", "message": "Record the win-builder results of R-devel and R-release in cran-comments.md\n", "time": 1793147199 }, "_distro": "resolute", "_host": "GitHub-Actions", "_registered": true, "_dependencies": [ { "package": "R", "version": ">= 3.5.0", "role": "Depends" }, { "package": "Rcpp", "role": "LinkingTo" }, { "package": "fpCompare", "role": "Imports" }, { "package": "ggplot2", "version": ">= 3.4.0", "role": "Imports" }, { "package": "Rcpp", "role": "Imports" }, { "package": "stats", "role": "Imports" }, { "package": "utils", "role": "Imports" }, { "package": "testthat", "version": ">= 3.1.7", "role": "Suggests" }, { "package": "knitr", "role": "Suggests" }, { "package": "rmarkdown", "role": "Suggests" }, { "package": "Exact", "role": "Suggests" }, { "package": "exact2x2", "role": "Suggests" }, { "package": "microbenchmark", "role": "Suggests" } ], "_owner": "gosukehommaex", "_selfowned": true, "_usedby": 0, "_updates": [ { "week": "2026-33", "n": 7 }, { "week": "2026-34", "n": 3 }, { "week": "2026-40", "n": 3 }, { "week": "2026-41", "n": 26 }, { "week": "2026-43", "n": 16 }, { "week": "2026-44", "n": 7 } ], "_tags": [ { "name": "v2.0.0", "date": "2026-08-20" } ], "_topics": [ "binary-endpoints", "clinical-trials", "power-calculation", "sample-size-calculation", "cpp" ], "_stars": 2, "_contributors": [ { "user": "gosukehommaex", "count": 109, "uuid": 210875127 } ], "_userbio": { "uuid": 210875127, "type": "user", "name": "Gosuke Homma PhD", "followers": 4, "description": "Biostatistician in a statistical methodology group at a pharmaceutical company. 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Method for bbssr_spowerbssr Objects", "topics": [ "summary.bbssr_spowerbssr" ] } ], "_pkglogo": "https://github.com/gosukehommaex/bbssr/raw/HEAD/man/figures/logo.png", "_readme": "https://github.com/gosukehommaex/bbssr/raw/HEAD/README.md", "_rundeps": [ "cli", "cpp11", "farver", "fpCompare", "ggplot2", "glue", "gtable", "isoband", "labeling", "lifecycle", "R6", "RColorBrewer", "Rcpp", "rlang", "S7", "scales", "vctrs", "viridisLite", "withr" ], "_sysdeps": [ { "shlib": "libstdc++", "package": "libstdc++6", "source": "gcc", "version": "16-20260322-1ubuntu1", "name": "c++", "homepage": "http://gcc.gnu.org/", "description": "GNU Standard C++ Library v3" } ], "_vignettes": [ { "source": "bbssr-design-grid.Rmd", "filename": "bbssr-design-grid.html", "title": "Comparing Designs with BinaryGridBSSR", "author": "Gosuke Homma", "engine": "knitr::rmarkdown", "headings": [ "One data frame for many designs", "Summaries and plots", "Initial sample sizes from a planning proportion", "Designs 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tests", "Two-sided conventions", "Unconditional tests", "Refining the maximum between the grid points", "Ties in the ordering statistic", "The Berger-Boos procedure", "Relationships between the tests", "Blinded sample size re-estimation", "The largest type I error rate", "Choosing a test", "References" ], "created": "2025-06-13 16:10:35", "modified": "2026-10-24 08:11:14", "commits": 11 }, { "source": "bbssr-stratified.Rmd", "filename": "bbssr-stratified.html", "title": "Stratified Designs", "author": "Gosuke Homma", "engine": "knitr::rmarkdown", "headings": [ "Design and notation", "Tests", "Power and sample size", "Blinded sample size re-estimation", "Type I error rate", "Analyses that ignore the strata", "Random stratum and group sizes", "Several designs", "Three or more strata", "References" ], "created": "2026-10-23 04:55:47", "modified": "2026-10-27 01:09:19", "commits": 9 }, { "source": "bbssr-type1-error.Rmd", "filename": "bbssr-type1-error.html", "title": "Type I Error Rate of 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