{"id":4710,"date":"2026-08-09T13:40:56","date_gmt":"2026-08-09T04:40:56","guid":{"rendered":"https:\/\/best-biostatistics.com\/toukei-er\/?p=4710"},"modified":"2026-08-09T13:40:57","modified_gmt":"2026-08-09T04:40:57","slug":"p-0-05-means-non-inferiority-will-get-rejected-immediately-valid-non-inferiority-survival-analysis-and-ich-e9-guidelines-2","status":"publish","type":"post","link":"https:\/\/best-biostatistics.com\/toukei-er\/entry\/p-0-05-means-non-inferiority-will-get-rejected-immediately-valid-non-inferiority-survival-analysis-and-ich-e9-guidelines-2\/","title":{"rendered":"P > 0.05\u3060\u304b\u3089\u975e\u52a3\u6027\u300d\u306f\u67fb\u8aad\u3067\u5373\u5374\u4e0b\uff01Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u306b\u3088\u308b\u975e\u52a3\u6027\u751f\u5b58\u6642\u9593\u89e3\u6790\u3068ICH-E9\u6e96\u62e0\u306e\u6b63\u653b\u6cd5"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\u300c\u5148\u751f\uff01\u4f4e\u4fb5\u8972\u306a\u65b0\u624b\u8853\u3068\u6a19\u6e96\u624b\u8853\u306e\u5168\u751f\u5b58\u671f\u9593\uff08OS\uff09\u3092\u6bd4\u8f03\u3057\u305f\u3068\u3053\u308d\u3001$P = 0.32$ \u3067\u6709\u610f\u5dee\u306a\u3057\u3067\u3057\u305f\uff01\u3064\u307e\u308a\u3001\u65b0\u624b\u8853\u306e\u975e\u52a3\u6027\u304c\u8a3c\u660e\u3055\u308c\u305f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3088\u306d\uff1f\u65e9\u901f\u8ad6\u6587\u3092\u66f8\u3053\u3046\u3068\u601d\u3044\u307e\u3059\uff01\u300d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2026\u2026\u3061\u3087\u3063\u3068\u5f85\u3063\u3066\u307b\u3057\u3044\u3002\u305d\u308c\u306f\u8ad6\u6587\u67fb\u8aad\uff08Peer Review\uff09\u306b\u304a\u3044\u3066\u3001\u67fb\u8aad\u8005\u304b\u3089\u4e00\u767a\u3067\u5374\u4e0b\u3055\u308c\u308b\u6700\u3082\u5371\u967a\u306a\u8aa4\u7528\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u81e8\u5e8a\u73fe\u5834\u3084\u5b66\u4f1a\u767a\u8868\u306b\u304a\u3044\u3066\u3001\u300c$P &gt; 0.05$\uff08\u6709\u610f\u5dee\u306a\u3057\uff09\uff1d \u5dee\u304c\u306a\u3044 \uff1d \u975e\u52a3\u6027\u3067\u3042\u308b\u300d\u3068\u89e3\u91c8\u3057\u3066\u3057\u307e\u3046\u30b1\u30fc\u30b9\u306f\u5f8c\u3092\u7d76\u305f\u306a\u3044\u3002\u3057\u304b\u3057\u3001\u4eee\u8aac\u691c\u5b9a\u306e\u8ad6\u7406\u69cb\u9020\u4e0a\u3001\u901a\u5e38\u306e\u512a\u8d8a\u6027\u8a66\u9a13\u306b\u304a\u3051\u308b\u300c\u6709\u610f\u5dee\u306a\u3057\u300d\u306f\u6c7a\u3057\u3066\u975e\u52a3\u6027\u306e\u8a3c\u660e\u306b\u306f\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u8a18\u4e8b\u3067\u306f\u3001\u751f\u5b58\u6642\u9593\u89e3\u6790\u306b\u304a\u3044\u3066<strong>\u306a\u305c <\/strong>$P &gt; 0.05$<strong> \u3067\u306f\u975e\u52a3\u6027\u3092\u4e3b\u5f35\u3067\u304d\u306a\u3044\u306e\u304b<\/strong>\u3068\u3044\u3046\u7406\u8ad6\u7684\u80cc\u666f\u304b\u3089\u3001\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08ICH-E9\uff09\u306b\u6e96\u62e0\u3057\u305f<strong>95%\u4fe1\u983c\u533a\u9593\u4e0a\u9650\uff08<\/strong>$\\text{CI}_{\\text{upper}}$<strong>\uff09\u3068\u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3\uff08<\/strong>$\\Delta$<strong>\uff09\u306b\u3088\u308b\u6b63\u5f53\u306a\u5224\u5b9a\u30eb\u30fc\u30eb<\/strong>\u3001<strong>ITT\u89e3\u6790\u3068PP\u89e3\u6790\u306e\u4e8c\u91cd\u691c\u8a3c<\/strong>\u3001\u305d\u3057\u3066<strong>R\u3067\u306e\u5b9f\u8df5\u30b3\u30fc\u30c9<\/strong>\u304a\u3088\u3073<strong>\u8ad6\u6587\u3067\u305d\u306e\u307e\u307e\u4f7f\u3048\u308b\u82f1\u6587\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/strong>\u307e\u3067\u3092\u5fb9\u5e95\u7684\u306b\u89e3\u8aac\u3059\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c1\u7ae0\uff1a\u306a\u305c\u300cP &gt; 0.05\uff08\u6709\u610f\u5dee\u306a\u3057\uff09\u300d\u3067\u975e\u52a3\u6027\u3092\u4e3b\u5f35\u3057\u3066\u306f\u3044\u3051\u306a\u3044\u306e\u304b\uff1f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">\u4eee\u8aac\u691c\u5b9a\u306e\u8ad6\u7406\u7684\u9650\u754c\uff1a\u300c\u8a3c\u660e\u306e\u4e0d\u5728\u300d\u3068\u300c\u4e0d\u5728\u306e\u8a3c\u660e\u300d<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u901a\u5e38\u306e\u512a\u8d8a\u6027\u8a66\u9a13\uff08Superiority trial\uff09\u3067\u8a2d\u5b9a\u3055\u308c\u308b\u5e30\u7121\u4eee\u8aac\u306f\u3001\u300c\u4e21\u7fa4\u306e\u30cf\u30b6\u30fc\u30c9\u306b\u5dee\u304c\u306a\u3044\uff08\u30cf\u30b6\u30fc\u30c9\u6bd4 $\\text{HR} = 1.0$\uff09\u300d\u3068\u3044\u3046\u3082\u306e\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u691c\u5b9a\u306b\u304a\u3044\u3066 $P &gt; 0.05$ \u3068\u306a\u308a\u5e30\u7121\u4eee\u8aac\u304c\u68c4\u5374\u3067\u304d\u306a\u304b\u3063\u305f\u5834\u5408\u3001\u5f97\u3089\u308c\u305f\u7d50\u8ad6\u306f\u300c\u4e21\u7fa4\u306b\u5dee\u304c\u3042\u308b\u3068\u306f\u8a00\u3044\u5207\u308c\u306a\u304b\u3063\u305f\u300d\u306b\u904e\u304e\u306a\u3044\u3002\u3053\u308c\u306f\u300c\u5dee\u304c\u306a\u3044\u3053\u3068\u304c\u8a3c\u660e\u3055\u308c\u305f\uff08Proof of Absence\uff09\u300d\u306e\u3067\u306f\u306a\u304f\u3001\u5358\u306b\u300c\u5dee\u304c\u3042\u308b\u8a3c\u62e0\u304c\u5f97\u3089\u308c\u306a\u304b\u3063\u305f\uff08Absence of Proof\uff09\u300d\u72b6\u614b\u3092\u793a\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f8b\u3048\u3070\u3001<strong>\u5358\u306b\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\uff08\u691c\u51fa\u529b\u304c\u4f4e\u3044\uff09\u4e0d\u5341\u5206\u306a\u81e8\u5e8a\u7814\u7a76\u3067\u3042\u3063\u3066\u3082\u3001<\/strong>$P &gt; 0.05$<strong> \u3068\u3044\u3046\u7d50\u679c\u306f\u5bb9\u6613\u306b\u5f97\u3089\u308c\u3066\u3057\u307e\u3046<\/strong>\u3002\u30c7\u30fc\u30bf\u304c\u4e0d\u5341\u5206\u3067\u7cbe\u5ea6\u304c\u4f4e\u3044\u3060\u3051\u306e\u89e3\u6790\u3092\u300c\u5dee\u304c\u306a\u3044\uff08\u975e\u52a3\u6027\u3067\u3042\u308b\uff09\u300d\u3068\u89e3\u91c8\u3057\u3066\u3057\u307e\u3046\u3053\u3068\u304c\u3001\u3069\u308c\u307b\u3069\u5371\u967a\u304b\u7406\u89e3\u3067\u304d\u308b\u3060\u308d\u3046\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u975e\u52a3\u6027\u8a66\u9a13\u306b\u304a\u3051\u308b\u6b63\u5f53\u306a\u4eee\u8aac\u8a2d\u5b9a<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u975e\u52a3\u6027\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u300c\u5dee\u304c\u306a\u3044\u300d\u3053\u3068\u3092\u5e30\u7121\u4eee\u8aac\u306b\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001<strong>\u300c\u8a31\u5bb9\u3067\u304d\u306a\u3044\u307b\u3069\u60aa\u5316\u3057\u3066\u3044\u308b\uff08\u52a3\u6027\u3067\u3042\u308b\uff09\u300d\u3053\u3068\u3092\u5e30\u7121\u4eee\u8aac\u306b\u8a2d\u5b9a\u3059\u308b<\/strong>\u5fc5\u8981\u304c\u3042\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65b0\u6cbb\u7642\u7fa4\u306e\u30a4\u30d9\u30f3\u30c8\u767a\u751f\u30cf\u30b6\u30fc\u30c9\u304c\u6a19\u6e96\u6cbb\u7642\u7fa4\u306b\u5bfe\u3057\u3066\u4f4e\u304f\u306a\u308b\u3053\u3068\uff08$\\text{HR} &lt; 1.0$\uff09\u3092\u300c\u81e8\u5e8a\u7684\u306b\u671b\u307e\u3057\u3044\uff08\u30ea\u30b9\u30af\u4f4e\u4e0b\uff09\u300d\u3068\u3059\u308b\u5834\u5408\u3001\u81e8\u5e8a\u7684\u306b\u300c\u3053\u308c\u4ee5\u4e0a\u306e\u60aa\u5316\u3067\u3042\u308c\u3070\u8a31\u5bb9\u3067\u304d\u308b\u300d\u3068\u3044\u3046\u9650\u754c\u5024\u3068\u3057\u3066\u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3 $\\Delta$\uff08\u901a\u5e38 $\\Delta &gt; 1.0$\uff09\u3092\u8a2d\u5b9a\u3059\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u3068\u304d\u3001\u975e\u52a3\u6027\u8a66\u9a13\u306e\u4eee\u8aac\u8a2d\u5b9a\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u53b3\u683c\u306b\u5b9a\u7fa9\u3055\u308c\u308b\u3002$$H_0: \\text{HR} \\ge \\Delta \\quad \\text{vs} \\quad H_1: \\text{HR} &lt; \\Delta$$<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u5e30\u7121\u4eee\u8aac\uff08<\/strong>$H_0$<strong>\uff09<\/strong>: \u52a3\u6027\u3067\u3042\u308b\uff08\u65b0\u6cbb\u7642\u306e\u30cf\u30b6\u30fc\u30c9\u304c\u8a31\u5bb9\u9650\u754c $\\Delta$ \u4ee5\u4e0a\u306b\u60aa\u5316\u3057\u3066\u3044\u308b\uff09<\/li>\n\n\n\n<li><strong>\u5bfe\u7acb\u4eee\u8aac\uff08<\/strong>$H_1$<strong>\uff09<\/strong>: \u975e\u52a3\u6027\u3067\u3042\u308b\uff08\u65b0\u6cbb\u7642\u306e\u30cf\u30b6\u30fc\u30c9\u60aa\u5316\u306f\u8a31\u5bb9\u9650\u754c $\\Delta$ \u672a\u6e80\u306b\u3068\u3069\u307e\u3063\u3066\u3044\u308b\uff09<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u5e30\u7121\u4eee\u8aac $H_0$ \u3092\u7d71\u8a08\u7684\u306b\u68c4\u5374\u3067\u304d\u3066\u521d\u3081\u3066\u3001\u300c\u975e\u52a3\u6027\u304c\u8a3c\u660e\u3055\u308c\u305f\u300d\u3068\u80f8\u3092\u5f35\u3063\u3066\u4e3b\u5f35\u3067\u304d\u308b\u306e\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c2\u7ae0\uff1a\u975e\u52a3\u6027\u5224\u5b9a\u306e\u7d76\u5bfe\u30eb\u30fc\u30eb\u300c95%\u4fe1\u983c\u533a\u9593\u4e0a\u9650\u300d\u3068\u300c\u30de\u30fc\u30b8\u30f3 $\\Delta$\u300d<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">95%\u4fe1\u983c\u533a\u9593\u6cd5\uff08Confidence Interval approach\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u751f\u5b58\u6642\u9593\u89e3\u6790\u306b\u304a\u3051\u308b\u975e\u52a3\u6027\u306e\u5224\u5b9a\u306f\u3001$P$ \u5024\u3067\u306f\u306a\u304f\u3001<strong>Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u304b\u3089\u7b97\u51fa\u3055\u308c\u308b\u30cf\u30b6\u30fc\u30c9\u6bd4\u306e\u4e21\u507495%\u4fe1\u983c\u533a\u9593\u306e\u4e0a\u9650\u5024\uff08<\/strong>$\\text{CI}_{\\text{upper}}$<strong>\uff09\u304c\u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3 <\/strong>$\\Delta$<strong> \u3092\u4e0b\u56de\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b<\/strong>\u3067\u5224\u65ad\u3059\u308b\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u975e\u52a3\u6027\u6210\u7acb\u306e\u5224\u5b9a\u6761\u4ef6<\/strong>: $\\text{CI}_{\\text{upper}} &lt; \\Delta$<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">\u8996\u899a\u7684\u30a4\u30e1\u30fc\u30b8\uff08\u5224\u5b9a\u306e3\u30d1\u30bf\u30fc\u30f3\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3\u3092 $\\Delta = 1.30$\uff08\u6a19\u6e96\u6cbb\u7642\u306b\u5bfe\u3057\u3066\u30cf\u30b6\u30fc\u30c9\u306e30%\u5897\u52a0\u307e\u3067\u8a31\u5bb9\uff09\u3068\u8a2d\u5b9a\u3057\u305f\u5834\u5408\u306e\u3001\u4fe1\u983c\u533a\u9593\u306b\u3088\u308b\u5224\u5b9a\u30d1\u30bf\u30fc\u30f3\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code>                      &#91;\u6a19\u6e96\u6cbb\u7642\u6709\u5229]       &#91;\u65b0\u6cbb\u7642\u4e0d\u5229]\n                                    |\n(1) \u975e\u52a3\u6027\u6210\u7acb         |--- Point ---||       (CI upper &lt; 1.30)\n                                    |        \n(2) \u975e\u52a3\u6027\u4e0d\u6210\u7acb        |------ Point ------| (CI upper >= 1.30)\n                                    |        \n(3) \u975e\u52a3\u6027\uff0b\u512a\u8d8a\u6027\u6210\u7acb |--Point--|     |       (CI upper &lt; 1.0)\n                                    |\n                          HR=1.0  \u0394=1.30\n<\/code><\/pre>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u975e\u52a3\u6027\u6210\u7acb\uff08Non-inferiority\uff09<\/strong>:\n<ul class=\"wp-block-list\">\n<li>\u6761\u4ef6: $\\text{CI}_{\\text{upper}} &lt; \\Delta$\uff08\u304b\u3064 $\\text{CI}_{\\text{upper}} \\ge 1.0$\uff09<\/li>\n\n\n\n<li>\u89e3\u91c8: 95%\u4fe1\u983c\u533a\u9593\u306e\u4e0a\u9650\u304c\u30de\u30fc\u30b8\u30f3 $\\Delta$ \u3092\u4e0b\u56de\u3063\u3066\u3044\u308b\u3002\u4eee\u306b\u65b0\u6cbb\u7642\u3067\u30cf\u30b6\u30fc\u30c9\u304c\u60aa\u5316\u3057\u3066\u3044\u305f\u3068\u3057\u3066\u3082\u3001\u305d\u306e\u7a0b\u5ea6\u306f\u8a31\u5bb9\u9650\u754c\uff0830%\u5897\uff09\u672a\u6e80\u3067\u3042\u308b\u3053\u3068\u304c\u7d71\u8a08\u7684\u306b\u793a\u3055\u308c\u305f\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u975e\u52a3\u6027\u4e0d\u6210\u7acb\uff08Inconclusive for Non-inferiority\uff09<\/strong>:\n<ul class=\"wp-block-list\">\n<li>\u6761\u4ef6: $\\text{CI}_{\\text{upper}} \\ge \\Delta$<\/li>\n\n\n\n<li>\u89e3\u91c8: \u305f\u3068\u3048\u70b9\u63a8\u5b9a\u5024\uff08HR\uff09\u304c $1.0$ \u672a\u6e80\uff08\u4f8b: $\\text{HR} = 0.95$\uff09\u3067\u3042\u3063\u3066\u3082\u3001$\\text{CI}_{\\text{upper}}$ \u304c $1.35$ \u306a\u3069\u3067\u30de\u30fc\u30b8\u30f3\u3092\u8d85\u3048\u3066\u3044\u308b\u5834\u5408\u3001<strong>\u975e\u52a3\u6027\u306f\u8a3c\u660e\u3055\u308c\u306a\u3044<\/strong>\u3002\u300c\u8a31\u5bb9\u3067\u304d\u306a\u3044\u307b\u3069\u60aa\u5316\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u300d\u3092\u6392\u9664\u3057\u5207\u308c\u3066\u3044\u306a\u3044\u305f\u3081\u3067\u3042\u308b\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u975e\u52a3\u6027 \uff0b \u512a\u8d8a\u6027\u306e\u6210\u7acb\uff08Superiority\uff09<\/strong>:\n<ul class=\"wp-block-list\">\n<li>\u6761\u4ef6: $\\text{CI}_{\\text{upper}} &lt; 1.0$<\/li>\n\n\n\n<li>\u89e3\u91c8: 95%\u4fe1\u983c\u533a\u9593\u306e\u4e0a\u9650\u304c $1.0$ \u3059\u3089\u4e0b\u56de\u3063\u3066\u3044\u308b\u3002\u65b0\u6cbb\u7642\u304c\u6a19\u6e96\u6cbb\u7642\u306b\u5bfe\u3057\u3066\u975e\u52a3\u6027\u3067\u3042\u308b\u3070\u304b\u308a\u304b\u3001\u7d71\u8a08\u7684\u306b\u6709\u610f\u306b\u512a\u308c\u3066\u3044\u308b\uff08\u512a\u8d8a\u6027\uff09\u3053\u3068\u304c\u540c\u6642\u306b\u8a3c\u660e\u3055\u308c\u305f\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">\u30b9\u30a4\u30c3\u30c1\u30f3\u30b0\uff081\/2\u30b9\u30c6\u30c3\u30d7\uff09\u30eb\u30fc\u30eb<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u3042\u3089\u304b\u3058\u3081\u4e8b\u524d\u898f\u5b9a\uff08Pre-specification\uff09\u3055\u308c\u3066\u3044\u308c\u3070\u3001\u975e\u52a3\u6027\u8a66\u9a13\u3068\u3057\u3066\u30c7\u30b6\u30a4\u30f3\u30fb\u89e3\u6790\u3092\u884c\u3063\u305f\u30c7\u30fc\u30bf\u306b\u304a\u3044\u3066\u975e\u52a3\u6027\u304c\u8a3c\u660e\u3055\u308c\u305f\uff08$\\text{CI}_{\\text{upper}} &lt; \\Delta$\uff09\u5f8c\u3001\u540c\u3058\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u512a\u8d8a\u6027\uff08$\\text{CI}_{\\text{upper}} &lt; 1.0$\uff09\u306e\u8a55\u4fa1\u3078\u79fb\u884c\u3059\u308b\u3053\u3068\u304c\u81e8\u5e8a\u8a66\u9a13\u306e\u30eb\u30fc\u30eb\u4e0a\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u969b\u3001\u591a\u91cd\u6027\uff08Multiplicity\uff09\u304c\u751f\u3058\u306a\u3044\u305f\u3081\u3001<strong>\u7b2c\u4e00\u7a2e\u306e\u8aa4\u308a\u7387\uff08<\/strong>$\\alpha$<strong> \u30a8\u30e9\u30fc\uff09\u306e\u8abf\u6574\u3092\u884c\u3046\u3053\u3068\u306a\u304f\u3001\u305d\u306e\u307e\u307e\u512a\u8d8a\u6027\u3092\u8a55\u4fa1\u30fb\u4e3b\u5f35\u3057\u3066\u5dee\u3057\u652f\u3048\u306a\u3044<\/strong>\u3002<\/p>\n\n\n\n<div id=\"biost-3868511244\" class=\"biost- biost-entity-placement\"><p style=\"text-align: center;\"><span style=\"font-size: 20px;\"><strong><a href=\"https:\/\/best-biostatistics.com\/kmhl\">\uff1e\uff1e\u3082\u3046\u7d71\u8a08\u3067\u60a9\u3080\u306e\u306f\u7d42\u308f\u308a\u306b\u3057\u307e\u305b\u3093\u304b\uff1f\u00a0<\/a><\/strong><\/span><\/p>\r\n<a href=\"https:\/\/best-biostatistics.com\/kmhl\"><img class=\"aligncenter wp-image-2794 size-full\" src=\"https:\/\/best-biostatistics.com\/wp\/wp-content\/uploads\/2023\/11\/bn_r_03.png\" alt=\"\" width=\"500\" height=\"327\" \/><\/a>\r\n<p style=\"text-align: center;\"><span style=\"color: #ff0000; font-size: 20px;\"><strong><span class=\"marker2\">\u21911\u4e07\u4eba\u4ee5\u4e0a\u306e\u533b\u7642\u5f93\u4e8b\u8005\u304c\u8cfc\u8aad\u4e2d<\/span><\/strong><\/span><\/p><\/div><h2 class=\"wp-block-heading\">\u7b2c3\u7ae0\uff1a\u975e\u52a3\u6027\u8a66\u9a13\u306b\u304a\u3051\u308b\u300cITT\u89e3\u6790\u300d\u306e\u7f60\u3068\u300cPP\u89e3\u6790\u300d\u306e\u5fc5\u9808\u6027\uff08ICH-E9\uff09<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">\u512a\u8d8a\u6027\u8a66\u9a13\u3068\u975e\u52a3\u6027\u8a66\u9a13\u3067\u306e\u30d0\u30a4\u30a2\u30b9\u306e\u5411\u304d<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u81e8\u5e8a\u8a66\u9a13\u306e\u89e3\u6790\u5bfe\u8c61\u96c6\u56e3\u306b\u306f\u3001\u5272\u4ed8\u901a\u308a\u306b\u5168\u75c7\u4f8b\u3092\u89e3\u6790\u3059\u308b <strong>ITT\uff08Intention-to-Treat\uff09\u96c6\u56e3<\/strong> \u3068\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u9055\u53cd\u8005\u3092\u9664\u5916\u3057\u305f <strong>PP\uff08Per-Protocol\uff09\u96c6\u56e3<\/strong> \u304c\u5b58\u5728\u3059\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e21\u8a66\u9a13\u306b\u304a\u3051\u308b\u30d0\u30a4\u30a2\u30b9\u306e\u50cd\u304f\u65b9\u5411\u306e\u9055\u3044\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u512a\u8d8a\u6027\u8a66\u9a13\u306b\u304a\u3051\u308bITT\u89e3\u6790<\/strong>: \u670d\u85ac\u4e0d\u9075\u5b88\u3084\u30c9\u30ed\u30c3\u30d7\u30a2\u30a6\u30c8\u306a\u3069\u306e\u30ce\u30a4\u30ba\u304c\u542b\u307e\u308c\u308b\u305f\u3081\u3001\u4e21\u7fa4\u9593\u306e\u5dee\u304c\u8584\u307e\u308b\u65b9\u5411\uff08$\\text{HR} \\to 1.0$\uff09\u3078\u50cd\u304f\u3002\u3053\u308c\u306f\u300c\u5dee\u304c\u3042\u308b\u300d\u3068\u4e3b\u5f35\u3057\u305f\u3044\u512a\u8d8a\u6027\u8a66\u9a13\u306b\u304a\u3044\u3066\u306f\u7d50\u679c\u3092\u4fdd\u5b88\u7684\uff08Safe\u5074\uff09\u306b\u3059\u308b\u305f\u3081\u3001\u512a\u8d8a\u6027\u8a66\u9a13\u3067\u306fITT\u89e3\u6790\u304c\u4e3b\u89e3\u6790\uff08Primary Analysis\uff09\u3068\u3055\u308c\u308b\u3002<\/li>\n\n\n\n<li><strong>\u975e\u52a3\u6027\u8a66\u9a13\u306b\u304a\u3051\u308bITT\u89e3\u6790<\/strong>: \u4e21\u7fa4\u9593\u306e\u5dee\u304c\u8584\u307e\u308b\u65b9\u5411\uff08$\\text{HR} \\to 1.0$\uff09\u306b\u50cd\u304f\u3053\u3068\u306f\u3001\u300c\u4e21\u7fa4\u306b\u5dee\u304c\u306a\u3044\uff1d\u975e\u52a3\u6027\u3067\u3042\u308b\u300d\u3068\u3044\u3046\u7d50\u8ad6\u3092\u5c0e\u304d\u3084\u3059\u304f\u3059\u308b\u3002\u3064\u307e\u308a\u3001ITT\u89e3\u6790\u306f\u975e\u52a3\u6027\u8a66\u9a13\u306b\u304a\u3044\u3066<strong>\u7d50\u679c\u3092\u975e\u4fdd\u5b88\u7684\uff08Unsafe\u5074 \/ \u975e\u52a3\u6027\u3092\u793a\u3057\u3084\u3059\u304f\u3059\u308b\u65b9\u5411\uff09\u306b\u30d0\u30a4\u30a2\u30b9\u3055\u305b\u308b<\/strong>\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">ICH-E9\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u57fa\u3065\u304f\u4e8c\u91cd\u691c\u8a3c\uff08Dual Evaluation\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u65e5\u7c73EU\u533b\u85ac\u54c1\u898f\u5236\u8abf\u548c\u56fd\u969b\u4f1a\u8b70\uff08ICH-E9\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u3067\u306f\u3001\u975e\u52a3\u6027\u8a66\u9a13\u306b\u304a\u3051\u308b\u3053\u306e\u30d0\u30a4\u30a2\u30b9\u30ea\u30b9\u30af\u3092\u9632\u6b62\u3059\u308b\u305f\u3081\u3001ITT\u89e3\u6790\u3068PP\u89e3\u6790\u306e\u4e21\u65b9\u3092\u5b9f\u65bd\u3057\u3001\u53cc\u65b9\u306e\u89e3\u6790\u3067\u4e00\u8cab\u3057\u3066\u975e\u52a3\u6027\u304c\u793a\u3055\u308c\u308b\u3053\u3068\uff08Dual Evaluation\uff09\u3092\u5f37\u304f\u6c42\u3081\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3b\u89e3\u6790\u3092ITT\u3067\u884c\u3046\u5834\u5408\u3067\u3082\u3001\u5fc5\u305aPP\u96c6\u56e3\u306b\u3088\u308b\u611f\u5ea6\u5206\u6790\uff08Sensitivity Analysis\uff09\u3092\u884c\u3044\u3001\u7d50\u8ad6\u304c\u63fa\u308b\u304c\u306a\u3044\u3053\u3068\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c4\u7ae0\uff1a\u3010\u5b9f\u8df5R\u30b3\u30fc\u30c9\u3011Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u306b\u3088\u308b\u975e\u52a3\u6027\u89e3\u6790\uff08Step by Step\uff09<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u3053\u304b\u3089\u306f\u3001R\u3092\u7528\u3044\u3066Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u306b\u3088\u308b\u975e\u52a3\u6027\u751f\u5b58\u6642\u9593\u89e3\u6790\u3092\u5b9f\u884c\u3059\u308b\u624b\u9806\u3092\u89e3\u8aac\u3059\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Step 1: \u7591\u4f3c\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u4f5c\u6210\u3068\u78ba\u8a8d<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><code>survival<\/code> \u30d1\u30c3\u30b1\u30fc\u30b8\u304a\u3088\u3073 <code>tidyverse<\/code> \u3092\u4f7f\u7528\u3057\u3001\u65b0\u6cbb\u7642\u7fa4\uff08New\uff09\u3068\u6a19\u6e96\u6cbb\u7642\u7fa4\uff08Standard\uff09\u306e\u751f\u5b58\u6642\u9593\u30c7\u30fc\u30bf\u3092\u751f\u6210\u3059\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code>library(survival)\nlibrary(tidyverse)\n\n# \u4e71\u6570\u30b7\u30fc\u30c9\u306e\u8a2d\u5b9a\nset.seed(123)\nn &lt;- 400\n\n# \u7591\u4f3c\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u4f5c\u6210\ndf &lt;- tibble(\n  id = 1:n,\n  group = factor(rep(c(\"Standard\", \"New\"), each = n \/ 2), levels = c(\"Standard\", \"New\")),\n  # \u751f\u5b58\u6642\u9593\uff08\u6708\uff09\u306e\u751f\u6210\n  futime = round(rexp(n, rate = if_else(rep(c(\"Standard\", \"New\"), each = n \/ 2) == \"Standard\", 0.03, 0.032)) * 12, 1),\n  event = rbinom(n, size = 1, prob = 0.7),\n  itt = 1,\n  # 10%\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u9055\u53cd\u8005\uff08PP\u304b\u3089\u9664\u5916\uff09\n  pp = if_else(runif(n) &gt; 0.10, 1, 0)\n) %&gt;%\n  mutate(\n    status = if_else(futime &gt; 60, 0, event),\n    time = if_else(futime &gt; 60, 60, futime)\n  )\n\n# \u30c7\u30fc\u30bf\u306e\u5148\u982d\u3092\u78ba\u8a8d\nhead(df)\n<\/code><\/pre>\n\n\n\n<h3 class=\"wp-block-heading\">Step 2: Kaplan-Meier\u66f2\u7dda\u306e\u63cf\u753b<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u751f\u5b58\u66f2\u7dda\u306e\u8996\u899a\u7684\u63a8\u79fb\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\"><strong>\u203b\u88dc\u8db3\uff08\u95a2\u9023\u8a18\u4e8b\uff09<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u306a\u304a\u3001Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u306e\u524d\u63d0\u6761\u4ef6\u3067\u3042\u308b\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u6027\u306e\u78ba\u8a8d\uff08Schoenfeld\u6b8b\u5dee\u30d7\u30ed\u30c3\u30c8\uff09\u306b\u3064\u3044\u3066\u306f\u3001[\u904e\u53bb\u8a18\u4e8b\uff1a<a href=\"https:\/\/best-biostatistics.com\/toukei-er\/entry\/handling-non-proportional-hazards-in-cox-regression-with-r-a-guide-to-rmst-stratification-and-time-varying-models\/\" data-type=\"link\" data-id=\"https:\/\/best-biostatistics.com\/toukei-er\/entry\/handling-non-proportional-hazards-in-cox-regression-with-r-a-guide-to-rmst-stratification-and-time-varying-models\/\">Cox\u56de\u5e30\u3067\u306e\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u6027\u7834\u7dbb\u3068RMST<\/a>] \u3092\u53c2\u7167\u3055\u308c\u305f\u3044\u3002<\/p>\n<\/blockquote>\n\n\n\n<pre class=\"wp-block-code\"><code>library(survminer)\n\n# ITT\u96c6\u56e3\u3067\u306eKaplan-Meier\u66f2\u7dda\u306e\u4f5c\u6210\nfit_km &lt;- survfit(Surv(time, status) ~ group, data = df)\n\n# \u30b0\u30e9\u30d5\u63cf\u753b\nggsurvplot(\n  fit_km,\n  data = df,\n  pval = FALSE, # \u901a\u5e38\u306eP\u5024\uff08H0: HR=1.0\uff09\u306f\u63cf\u753b\u3057\u306a\u3044\n  conf.int = TRUE,\n  risk.table = TRUE,\n  legend.labs = c(\"Standard\", \"New\"),\n  palette = c(\"#2E9FDF\", \"#E7B800\"),\n  title = \"Overall Survival (ITT Population)\",\n  xlab = \"Time (Months)\",\n  ylab = \"Survival Probability\"\n)\n<\/code><\/pre>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"575\" height=\"483\" src=\"https:\/\/best-biostatistics.com\/toukei-er\/wp-content\/uploads\/2026\/08\/image-6.png\" alt=\"\" class=\"wp-image-4711\" srcset=\"https:\/\/best-biostatistics.com\/toukei-er\/wp-content\/uploads\/2026\/08\/image-6.png 575w, https:\/\/best-biostatistics.com\/toukei-er\/wp-content\/uploads\/2026\/08\/image-6-300x252.png 300w\" sizes=\"(max-width: 575px) 100vw, 575px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">Step 3: Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u306e\u5b9f\u884c\u306895% CI\u4e0a\u9650\u306e\u7b97\u51fa<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><code>survival::coxph<\/code> \u95a2\u6570\u3092\u7528\u3044\u3066Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u3092\u69cb\u7bc9\u3057\u3001\u30cf\u30b6\u30fc\u30c9\u6bd4\uff08HR\uff09\u3068\u305d\u306e\u4e21\u507495%\u4fe1\u983c\u533a\u9593\u306e\u4e0a\u9650\u5024\u3092\u53d6\u5f97\u3059\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code># ITT\u96c6\u56e3\u306b\u5bfe\u3059\u308bCox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\ncox_itt &lt;- coxph(Surv(time, status) ~ group, data = df)\nsum_itt &lt;- summary(cox_itt)\n\n# \u30cf\u30b6\u30fc\u30c9\u6bd4\u3001\u6a19\u6e96\u8aa4\u5dee\u3001\u4e21\u507495%\u4fe1\u983c\u533a\u9593\u306e\u53d6\u5f97\nhr_itt &lt;- sum_itt$coefficients&#91;\"groupNew\", \"exp(coef)\"]\nse_itt &lt;- sum_itt$coefficients&#91;\"groupNew\", \"se(coef)\"]\nci_lower_itt &lt;- sum_itt$conf.int&#91;\"groupNew\", \"lower .95\"]\nci_upper_itt &lt;- sum_itt$conf.int&#91;\"groupNew\", \"upper .95\"]\n\ncat(sprintf(\"ITT Population Results:\\n\"))\ncat(sprintf(\"HR: %.3f (95%% CI: %.3f - %.3f)\\n\", hr_itt, ci_lower_itt, ci_upper_itt))\n<\/code><\/pre>\n\n\n\n<p class=\"wp-block-paragraph\">\u7d50\u679c\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a 95% \u4fe1\u983c\u533a\u9593\u4e0a\u9650\u5024\u306f\u30011.884 \u3068\u306a\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code>> cat(sprintf(\"ITT Population Results:\\n\"))\nITT Population Results:\n> cat(sprintf(\"HR: %.3f (95%% CI: %.3f - %.3f)\\n\", hr_itt, ci_lower_itt, ci_upper_itt))\nHR: 1.013 (95% CI: 0.545 - 1.884)<\/code><\/pre>\n\n\n\n<h3 class=\"wp-block-heading\">Step 4: \u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3\uff08$\\Delta = 1.30$\uff09\u3068\u306e\u6bd4\u8f03\u304a\u3088\u3073\u7247\u5074 P \u5024\u306e\u7b97\u51fa<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3\u3092 $\\Delta = 1.30$ \u3068\u8a2d\u5b9a\u3059\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7247\u5074Wald\u691c\u5b9a\u306b\u3088\u308b\u975e\u52a3\u6027\u306e $P$ \u5024\uff08$P_{\\text{NI}}$\uff09\u306f\u3001\u4ee5\u4e0b\u306e\u6570\u5f0f\u3067\u5f97\u3089\u308c\u308b $Z$ \u30b9\u30b3\u30a2\u3092\u7528\u3044\u3066\u7b97\u51fa\u3059\u308b\u3002$$Z = \\frac{\\ln(\\text{HR}) &#8211; \\ln(\\Delta)}{\\text{SE}(\\ln(\\text{HR}))}$$<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e $Z$ \u30b9\u30b3\u30a2\u304b\u3089\u6a19\u6e96\u6b63\u898f\u5206\u5e03\u306e\u7d2f\u7a4d\u78ba\u7387\uff08R\u306e <code>pnorm<\/code> \u95a2\u6570\uff09\u3092\u6c42\u3081\u308b\u3053\u3068\u3067\u3001\u7247\u5074\u975e\u52a3\u6027 $P$ \u5024\u304c\u8a08\u7b97\u3067\u304d\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code># \u30de\u30fc\u30b8\u30f3\u306e\u8a2d\u5b9a\nmargin &lt;- 1.30\n\n# \u7247\u5074\u691c\u5b9a\u7d71\u8a08\u91cf Z \u304a\u3088\u3073 P\u5024\u306e\u8a08\u7b97\nz_ni_itt &lt;- (log(hr_itt) - log(margin)) \/ se_itt\np_ni_itt &lt;- pnorm(z_ni_itt)\n\ncat(sprintf(\"One-sided P-value for Non-Inferiority: %.4f\\n\", p_ni_itt))\n\n# \u975e\u52a3\u6027\u306e\u5224\u5b9a\nif (ci_upper_itt &lt; margin) {\n  cat(\"Conclusion: Non-inferiority is ESTABLISHED (CI upper &lt; Margin)\\n\")\n} else {\n  cat(\"Conclusion: Non-inferiority is NOT established (CI upper &gt;= Margin)\\n\")\n}\n<\/code><\/pre>\n\n\n\n<p class=\"wp-block-paragraph\">\u7d50\u679c\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3001\u975e\u52a3\u6027\u78ba\u8a8d\u3067\u304d\u305a\u3001\u3068\u306a\u308b\u30021.30 \u304c\u975e\u52a3\u6027\u306e\u9650\u754c\u5024\u3068\u8003\u3048\u305f\u3068\u304d\u30011.884 \u304c 95% \u4fe1\u983c\u533a\u9593\u4e0a\u9650\u3068\u306a\u308b\u3068\u3001\u52a3\u308b\u3053\u3068\u304c\u3042\u308a\u3046\u308b\u3068\u3044\u3046\u7d50\u8ad6\u3067\u3001\u975e\u52a3\u6027\u306f\u78ba\u8a8d\u3067\u304d\u306a\u3044\u308f\u3051\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code>One-sided P-value for Non-Inferiority: 0.2155\nConclusion: Non-inferiority is NOT established (CI upper >= Margin)<\/code><\/pre>\n\n\n\n<h3 class=\"wp-block-heading\">Step 5: ITT\u96c6\u56e3 vs PP\u96c6\u56e3\u306e\u611f\u5ea6\u5206\u6790\uff08Sensitivity Analysis\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ICH-E9\u306b\u5247\u308a\u3001PP\u96c6\u56e3\u3067\u3082\u540c\u69d8\u306e\u89e3\u6790\u3092\u884c\u3044\u3001\u7d50\u8ad6\u306e\u4e00\u8cab\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code># PP\u96c6\u56e3\uff08pp == 1\uff09\u306b\u5bfe\u3059\u308bCox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\ncox_pp &lt;- coxph(Surv(time, status) ~ group, data = df, subset = (pp == 1))\nsum_pp &lt;- summary(cox_pp)\n\nhr_pp &lt;- sum_pp$coefficients&#91;\"groupNew\", \"exp(coef)\"]\nse_pp &lt;- sum_pp$coefficients&#91;\"groupNew\", \"se(coef)\"]\nci_lower_pp &lt;- sum_pp$conf.int&#91;\"groupNew\", \"lower .95\"]\nci_upper_pp &lt;- sum_pp$conf.int&#91;\"groupNew\", \"upper .95\"]\n\nz_ni_pp &lt;- (log(hr_pp) - log(margin)) \/ se_pp\np_ni_pp &lt;- pnorm(z_ni_pp)\n\ncat(sprintf(\"\\nPP Population Results:\\n\"))\ncat(sprintf(\"HR: %.3f (95%% CI: %.3f - %.3f)\\n\", hr_pp, ci_lower_pp, ci_upper_pp))\ncat(sprintf(\"One-sided P-value for Non-Inferiority: %.4f\\n\", p_ni_pp))\n<\/code><\/pre>\n\n\n\n<p class=\"wp-block-paragraph\">PP\u96c6\u56e3\u3067\u3082\u540c\u69d8\u306e\u7d50\u679c\u3067\u3042\u3063\u305f\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code>PP Population Results:\nHR: 1.052 (95% CI: 0.552 - 2.005)\nOne-sided P-value for Non-Inferiority: 0.2600<\/code><\/pre>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c5\u7ae0\uff1a\u8ad6\u6587\u3067\u305d\u306e\u307e\u307e\u4f7f\u3048\u308b\u82f1\u6587\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08Methods &amp; Results\uff09<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8ad6\u6587\uff08Methods\u304a\u3088\u3073Results\u30bb\u30af\u30b7\u30e7\u30f3\uff09\u306b\u8a18\u8f09\u3059\u308b\u969b\u306e\u6a19\u6e96\u7684\u306a\u82f1\u6587\u8868\u73fe\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u793a\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Methods \u30bb\u30af\u30b7\u30e7\u30f3\u82f1\u6587\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/h3>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">&#8220;The primary objective of this study was to evaluate the non-inferiority of [New Treatment] compared to [Standard Treatment] in terms of overall survival (OS). The non-inferiority margin for the hazard ratio (HR) was pre-specified at$\\Delta = 1.30$. Hazard ratios and their 95% confidence intervals (CIs) were estimated using a Cox proportional hazards model. Non-inferiority was declared if the upper bound of the two-sided 95% CI for HR was less than 1.30, corresponding to a one-sided significance level of$\\alpha = 0.025$. In accordance with the ICH-E9 guidelines, non-inferiority analyses were performed on both the intention-to-treat (ITT) and per-protocol (PP) populations to ensure consistency of the findings.&#8221;<\/p>\n<\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">Results \u30bb\u30af\u30b7\u30e7\u30f3\u82f1\u6587\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/h3>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">&#8220;In the ITT population, the hazard ratio for overall survival in the [New Treatment] group relative to the [Standard Treatment] group was [0.98] (95% CI, [0.75] to [1.24]). The upper bound of the 95% CI ([1.24]) was below the pre-specified non-inferiority margin of 1.30 (one-sided$P$for non-inferiority = [0.012]). Consistent results were observed in the per-protocol analysis (HR [0.96], 95% CI [[0.73] to [1.22]], one-sided$P$for non-inferiority = [0.008]). Thus, [New Treatment] was demonstrated to be non-inferior to [Standard Treatment].&#8221;<\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\">\u307e\u3068\u3081\uff06\u4e00\u62ec\u30b3\u30d4\u30da\u7528R\u30b9\u30af\u30ea\u30d7\u30c8<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">\u672c\u8a18\u4e8b\u306e\u30dd\u30a4\u30f3\u30c8\u307e\u3068\u3081<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>$P > 0.05$<strong>\uff08\u6709\u610f\u5dee\u306a\u3057\uff09\u306f\u975e\u52a3\u6027\u306e\u8a3c\u660e\u3067\u306f\u306a\u3044<\/strong>: \u5358\u306a\u308b\u691c\u51fa\u529b\u4e0d\u8db3\u3067\u3082 $P > 0.05$ \u306b\u306a\u308b\u3002\u300c\u5dee\u304c\u3042\u308b\u3068\u8a00\u3044\u5207\u308c\u306a\u3044\u300d\u3053\u3068\u3068\u300c\u5dee\u304c\u306a\u3044\u300d\u3053\u3068\u306f\u5168\u304f\u5225\u7269\u3067\u3042\u308b\u3002<\/li>\n\n\n\n<li><strong>\u8a55\u4fa1\u57fa\u6e96\u306f95%\u4fe1\u983c\u533a\u9593\u306e\u4e0a\u9650\uff08<\/strong>$\\text{CI}_{\\text{upper}}$<strong>\uff09<\/strong>: \u70b9\u63a8\u5b9a\u5024\u3067\u306f\u306a\u304f\u3001$\\text{CI}_{\\text{upper}} &lt; \\Delta$\uff08\u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3\uff09\u3092\u6e80\u305f\u3059\u304b\u3069\u3046\u304b\u3067\u5224\u5b9a\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>ITT\u89e3\u6790\u3068PP\u89e3\u6790\u306e\u4e8c\u91cd\u691c\u8a3c\u304c\u5fc5\u9808\uff08ICH-E9\uff09<\/strong>: \u975e\u52a3\u6027\u8a66\u9a13\u3067\u306fITT\u89e3\u6790\u304c\u7d50\u679c\u3092\u300c\u975e\u52a3\u6027\u5074\u300d\u3078\u30d0\u30a4\u30a2\u30b9\u3055\u305b\u308b\u30ea\u30b9\u30af\u304c\u3042\u308b\u305f\u3081\u3001PP\u89e3\u6790\u3067\u306e\u7d50\u679c\u306e\u4e00\u81f4\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">\u4e00\u62ec\u5b9f\u884c\u7528R\u30b9\u30af\u30ea\u30d7\u30c8<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u306e\u30b3\u30fc\u30c9\u3092\u30b3\u30d4\u30fc\uff06\u30da\u30fc\u30b9\u30c8\u3059\u308b\u3053\u3068\u3067\u3001\u30c7\u30fc\u30bf\u4f5c\u6210\u304b\u3089Cox\u6bd4\u4f8b\u30cf\u30b6\u30fc\u30c9\u30e2\u30c7\u30eb\u5b9f\u884c\u3001\u975e\u52a3\u6027\u5224\u5b9a\u3001\u7247\u5074 $P$ \u5024\u7b97\u51fa\u3001ITT\/PP\u6bd4\u8f03\u51fa\u529b\u307e\u3067\u3092\u4e00\u62ec\u3057\u3066\u5b9f\u884c\u3067\u304d\u308b\u3002<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code># ==============================================================================\n# \u975e\u52a3\u6027\u751f\u5b58\u6642\u9593\u89e3\u6790\uff08Non-inferiority Survival Analysis\uff09\u4e00\u62ec\u5b9f\u884c\u30b9\u30af\u30ea\u30d7\u30c8\n# ==============================================================================\n\nlibrary(survival)\nlibrary(tidyverse)\n\n# 1. \u7591\u4f3c\u30c7\u30fc\u30bf\u306e\u751f\u6210\nset.seed(123)\nn &lt;- 400\ndf &lt;- tibble(\n  id = 1:n,\n  group = factor(rep(c(\"Standard\", \"New\"), each = n \/ 2), levels = c(\"Standard\", \"New\")),\n  futime = round(rexp(n, rate = if_else(rep(c(\"Standard\", \"New\"), each = n \/ 2) == \"Standard\", 0.03, 0.032)) * 12, 1),\n  event = rbinom(n, size = 1, prob = 0.7),\n  itt = 1,\n  pp = if_else(runif(n) > 0.10, 1, 0)\n) %>%\n  mutate(\n    status = if_else(futime > 60, 0, event),\n    time = if_else(futime > 60, 60, futime)\n  )\n\n# 2. \u89e3\u6790\u8a2d\u5b9a\nmargin &lt;- 1.30 # \u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3 \u0394\n\n# 3. \u89e3\u6790\u95a2\u6570\u5b9a\u7fa9\nanalyze_non_inferiority &lt;- function(data, pop_name, subset_condition = NULL) {\n  if (!is.null(subset_condition)) {\n    sub_data &lt;- data %>% filter(eval(parse(text = subset_condition)))\n  } else {\n    sub_data &lt;- data\n  }\n\n  fit &lt;- coxph(Surv(time, status) ~ group, data = sub_data)\n  s &lt;- summary(fit)\n\n  hr &lt;- s$coefficients&#91;\"groupNew\", \"exp(coef)\"]\n  se &lt;- s$coefficients&#91;\"groupNew\", \"se(coef)\"]\n  ci_lower &lt;- s$conf.int&#91;\"groupNew\", \"lower .95\"]\n  ci_upper &lt;- s$conf.int&#91;\"groupNew\", \"upper .95\"]\n\n  # \u7247\u5074P\u5024\u306e\u7b97\u51fa\n  z &lt;- (log(hr) - log(margin)) \/ se\n  p_val &lt;- pnorm(z)\n\n  ni_status &lt;- if_else(ci_upper &lt; margin, \"Non-inferiority Established\", \"NOT Established\")\n\n  return(tibble(\n    Population = pop_name,\n    N = nrow(sub_data),\n    HR = round(hr, 3),\n    `95% CI Lower` = round(ci_lower, 3),\n    `95% CI Upper` = round(ci_upper, 3),\n    `Margin (Delta)` = margin,\n    `One-sided P (NI)` = round(p_val, 4),\n    `Conclusion` = ni_status\n  ))\n}\n\n# 4. ITT\u304a\u3088\u3073PP\u89e3\u6790\u306e\u5b9f\u884c\u3068\u7d50\u679c\u8868\u793a\nresults_itt &lt;- analyze_non_inferiority(df, \"ITT Population\")\nresults_pp &lt;- analyze_non_inferiority(df, \"PP Population\", subset_condition = \"pp == 1\")\n\nfinal_summary &lt;- bind_rows(results_itt, results_pp)\n\ncat(\"\\n==============================================================================\\n\")\ncat(\"                       NON-INFERIORITY ANALYSIS SUMMARY                       \\n\")\ncat(\"==============================================================================\\n\\n\")\nprint(as.data.frame(final_summary))\ncat(\"\\n==============================================================================\\n\")\n<\/code><\/pre>\n\n\n\n<h2 class=\"wp-block-heading\">\u304a\u3059\u3059\u3081\u66f8\u7c4d<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/amzn.to\/4fYNJYx\">\u8ab0\u3082\u6559\u3048\u3066\u304f\u308c\u306a\u304b\u3063\u305f\u3000\u533b\u7642\u7d71\u8a08\u306e\u4f7f\u3044\u5206\u3051\u301c\u8ff7\u3044\u3084\u3059\u3044\u89e3\u6790\u624b\u6cd5\u306e\u9078\u3073\u65b9\u304c\uff0cR\u3067\u5b9f\u611f\u3057\u306a\u304c\u3089\u308f\u304b\u308b\uff01<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u300c\u5148\u751f\uff01\u4f4e\u4fb5\u8972\u306a\u65b0\u624b\u8853\u3068\u6a19\u6e96\u624b\u8853\u306e\u5168\u751f\u5b58\u671f\u9593\uff08OS\uff09\u3092\u6bd4\u8f03\u3057\u305f\u3068\u3053\u308d\u3001$P = 0.32$ \u3067\u6709\u610f\u5dee\u306a\u3057\u3067\u3057\u305f\uff01\u3064\u307e\u308a\u3001\u65b0\u624b\u8853\u306e\u975e\u52a3\u6027\u304c\u8a3c\u660e\u3055\u308c\u305f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3088\u306d\uff1f\u65e9\u901f\u8ad6\u6587\u3092\u66f8\u3053\u3046\u3068\u601d\u3044\u307e\u3059\uff01\u300d \u2026\u2026\u3061\u3087\u3063\u3068\u5f85\u3063\u3066\u307b\u3057 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4712,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"swell_btn_cv_data":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[21],"tags":[],"class_list":["post-4710","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-21"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/best-biostatistics.com\/toukei-er\/wp-content\/uploads\/2026\/08\/\u975e\u52a3\u6027\u751f\u5b58\u6642\u9593\u89e3\u6790-scaled.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/posts\/4710","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/comments?post=4710"}],"version-history":[{"count":4,"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/posts\/4710\/revisions"}],"predecessor-version":[{"id":4716,"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/posts\/4710\/revisions\/4716"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/media\/4712"}],"wp:attachment":[{"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/media?parent=4710"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/categories?post=4710"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/best-biostatistics.com\/toukei-er\/wp-json\/wp\/v2\/tags?post=4710"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}