{"id":8735,"date":"2021-02-08T12:30:24","date_gmt":"2021-02-08T12:30:24","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8735"},"modified":"2022-11-14T07:12:33","modified_gmt":"2022-11-14T07:12:33","slug":"how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/","title":{"rendered":"How to Develop a Statistical Analysis Plan (SAP) For Clinical Trials"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f229a8a78b1\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f229a8a78b1\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/#1_Statistical_Analysis_Plan_SAP_in_a_Clinical_Trial_CT\" title=\"1.\u81e8\u5e8a\u8a66\u9a13(CT)\u306b\u304a\u3051\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b(SAP)\">1.\u81e8\u5e8a\u8a66\u9a13(CT)\u306b\u304a\u3051\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b(SAP)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/#2_Importance_of_the_Statistical_Analysis_Plan_in_Clinical_Trials\" title=\"2.\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b\u306e\u91cd\u8981\u6027\">2.\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b\u306e\u91cd\u8981\u6027<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/#3_Detailed_checklistguidelines_for_SAPs_in_clinical_trials\" title=\"3.\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308bSAP\u306e\u8a73\u7d30\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\/\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\">3.\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308bSAP\u306e\u8a73\u7d30\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\/\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/#4_What_does_an_SAP_consist_of\" title=\"4.SAP\u306f\u4f55\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u308b\u306e\u3067\u3059\u304b\uff1f\">4.SAP\u306f\u4f55\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u308b\u306e\u3067\u3059\u304b\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/#5_Hiring_a_freelance_clinical_statistician_for_help_with_SAPs\" title=\"5.\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u7d71\u8a08\u5bb6\u3092\u96c7\u3063\u3066SAP\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u3057\u3066\u3082\u3089\u3046\">5.\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u7d71\u8a08\u5bb6\u3092\u96c7\u3063\u3066SAP\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u3057\u3066\u3082\u3089\u3046<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Kolabtree freelance <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\">biostatistician consultant<\/a>, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/paresh-patel\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=SAP\">\u30eb\u30c9\u30e9\u30fb\u30d1\u30c6\u30eb<\/a> \u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u7d71\u8a08\u89e3\u6790\u8a08\u753b\uff08SAP\uff09\u3092\u3069\u306e\u3088\u3046\u306b\u4f5c\u6210\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u306e\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 <\/em>\u00a0<strong>\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Statistical_Analysis_Plan_SAP_in_a_Clinical_Trial_CT\"><\/span><strong>1.\u81e8\u5e8a\u8a66\u9a13(CT)\u306b\u304a\u3051\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b(SAP)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3092\u9ad8\u3081\u308b\u305f\u3081\u306b\u306f\u3001\u3088\u304f\u66f8\u304b\u308c\u305f\u5b8c\u5168\u306a\u7d71\u8a08\u5206\u6790\u8a08\u753b\uff08SAP\uff09\u304c\u91cd\u8981\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=SAP\">\u81e8\u5e8a\u8a66\u9a13\u306e\u8cea<\/a> \u3068\u3001\u3088\u308a\u6709\u52b9\u3067\u4e00\u822c\u5316\u3055\u308c\u305f\u3082\u306e\u306b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<aside class=\"modern-quote pull alignleft\"><strong>\"\u30d7\u30e9\u30f3\u30cb\u30f3\u30b0\u3068\u306f\u3001\u672a\u6765\u3092\u73fe\u5728\u306b\u6301\u3063\u3066\u304d\u3066\u3001\u4eca\u305d\u308c\u306b\u5bfe\u3057\u3066\u4f55\u304b\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u3060\" - \u30a2\u30e9\u30f3\u30fb\u30ec\u30fc\u30ad\u30f3<\/strong><\/aside>\n<p>SAP\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5206\u6790\u306e\u305f\u3081\u306b\u8a08\u753b\u3055\u308c\u305f\u7d71\u8a08\u5b66\u7684\u306a\u57fa\u672c\u7684\/\u767a\u5c55\u7684\u306a\u65b9\u6cd5\u306e\u5b9a\u7fa9\u3055\u308c\u305f\u6982\u8981\u3067\u3042\u308a\u3001\u8a66\u9a13\u8a08\u753b\u66f8\u306e\u4e2d\u306b\u8a18\u8ff0\u3055\u308c\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u500b\u5225\u306b\u8a18\u8ff0\u3055\u308c\u307e\u3059\u3002  SAP\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3042\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u958b\u767a\u306b\u304a\u3051\u308b\u91cd\u8981\u306a\u898f\u5236\u4e0a\u306e\u6a5f\u5bc6\u6587\u66f8\u306e1\u3064\u3067\u3059\u3002SAP\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u958b\u767a\u306e\u4e2d\u3067\u3082\u3001\u7d71\u8a08\u5b66\u7684\u624b\u6cd5\u3001\u533b\u5b66\u7528\u8a9e\u3001\u8996\u899a\u5316\u80fd\u529b\u306b\u7cbe\u901a\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u96e3\u6613\u5ea6\u306e\u9ad8\u3044\u30bf\u30b9\u30af\u3067\u3059\u3002SAP\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u7d71\u8a08\u7684\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u3068\u7d50\u679c\u306e\u30d7\u30ec\u30bc\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u3059\u308b\u660e\u78ba\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u3067\u306f\u3001\u4ee5\u4e0b\u306e4\u3064\u306e\u91cd\u8981\u306a\u30bf\u30a4\u30d7\u306eSAP\u304c\u4f7f\u7528\u3055\u308c\u307e\u3059\uff08\u56f31\uff09\u3002<\/p>\n<ul>\n<li>\u30c7\u30fc\u30bf\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/li>\n<li>\u4e2d\u9593\u7d71\u8a08\u89e3\u6790<\/li>\n<li>\u7d71\u5408\u7d71\u8a08\u89e3\u6790\u8a08\u753b<\/li>\n<li>\u81e8\u5e8a\u8a66\u9a13\u306e\u7d71\u8a08\u89e3\u6790\u8a08\u753b<\/li>\n<\/ul>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8738\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap1.jpg\" alt=\"\" width=\"424\" height=\"273\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap1.jpg 780w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap1-300x193.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap1-768x494.jpg 768w\" sizes=\"(max-width: 424px) 100vw, 424px\" \/><\/p>\n<p><strong>\u56f31\uff1aCT\u3067\u306f4\u3064\u306e\u91cd\u8981\u306a\u30bf\u30a4\u30d7\u306eSAP\u304c\u4f7f\u308f\u308c\u3066\u3044\u308b<\/strong><\/p>\n<p>SAP\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u5834\u5408\u3001\u72ec\u7acb\u3057\u305f\u6587\u66f8\u3068\u3057\u3066\u4f5c\u6210\u3055\u308c\u308b\u304b\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u7d71\u8a08\u7684\u90e8\u5206\u3092\u6271\u3046\u305f\u3081\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u3068\u3057\u3066CT\u8a66\u9a13\u8a08\u753b\u66f8\u306b\u542b\u307e\u308c\u3066\u3044\u308b\u3002\u30c1\u30fc\u30e0\u533b\u7642\u7d71\u8a08\u5b66\u8005\uff0f\u751f\u7269\u7d71\u8a08\u5b66\u8005\u304c\u3001CT\u8a66\u9a13\u306e\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3068\u9023\u643a\u3057\u3066SAP\u306e\u4f5c\u6210\u3092\u62c5\u5f53\u3059\u308b\u3002\u3053\u306e\u6587\u66f8\u306f\u3001\u5be9\u67fb\u59d4\u54e1\u4f1a\u3084\u898f\u5236\u5f53\u5c40\u306b\u63d0\u51fa\u3059\u308b\u524d\u306b\u3001Senior Biostatistician\u306e\u30ec\u30d3\u30e5\u30fc\u3092\u53d7\u3051\u3001\u6700\u7d42\u6c7a\u5b9a\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u304c\u4fee\u6b63\u3055\u308c\u305f\u5834\u5408\u306b\u306f\u3001SAP \u3082\u4fee\u6b63\u3055\u308c\u308b\u3002<\/p>\n<p>SAP \u306f\u3001\u76ee\u7684\u304a\u3088\u3073\u4e3b\u8981\u76ee\u7684\u3001\u526f\u6b21\u7684\u76ee\u7684\u3001\u63a2\u7d22\u7684\u76ee\u7684\u3001\u4e3b\u8981\uff0f\u526f\u6b21\uff0f\u63a2\u7d22\u7684\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001\u8a66\u9a13\u96c6\u56e3\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3001\u6b63\u5f53\u5316\uff0f\u524d\u63d0\u6761\u4ef6\u3092\u4f34\u3046\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u306e\u8a08\u7b97\u3001\u304a\u3088\u3073\u7121\u4f5c\u70ba\u5316\u65b9\u6cd5\u306b\u3064\u3044\u3066\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u9069\u5207\u306b\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3055\u3089\u306b\u3001SAP\u306f\u7d71\u8a08\u7684\u624b\u6cd5\uff08\u6709\u52b9\u6027\u89e3\u6790\u3001\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u89e3\u6790\u3001\u5831\u544a\u898f\u5247\u306a\u3069\uff09\u3092\u8a73\u7d30\u306b\u8a18\u8ff0\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u56f32\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u8a66\u9a13\u8a08\u753b\u66f8\u3067SAP\u3092\u4f5c\u6210\u3059\u308b\u969b\u306b\u8003\u616e\u3059\u3079\u304d\u6700\u3082\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8739\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap2.jpg\" alt=\"\" width=\"433\" height=\"407\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap2.jpg 566w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap2-300x282.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap2-24x24.jpg 24w\" sizes=\"(max-width: 433px) 100vw, 433px\" \/><\/p>\n<p><strong>\u56f32\uff1aCT\u30d7\u30ed\u30c8\u30b3\u30eb\u3067SAP\u3092\u958b\u767a\u3059\u308b\u969b\u306b\u8003\u616e\u3059\u3079\u304d\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u306e\u8a73\u7d30\u3002<\/strong><\/p>\n<p>\u4f5c\u6210\u3055\u308c\u305f\u89e3\u6790\u8a08\u753b\u306f\u3001\u5f53\u5c40\u306b\u3088\u308b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u306e\u524d\u306b\u3001\u7279\u5225\u306a\u6ce8\u610f\u3092\u6255\u3063\u3066\u691c\u8a0e\u3055\u308c\u3001\u4e0a\u7d1a\u76f2\u691c\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002 <a href=\"https:\/\/www.phusewiki.org\/wiki\/index.php?title=Review_of_Statistical_Analysis_Plans%20\">Ahrweiler et al.<\/a> \u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u767a\u8868\u3055\u308c\u305f\u5b66\u4f1a\u8ad6\u6587\u3067\u306f\u3001\u7d71\u8a08\u89e3\u6790\u8a08\u753b\u306e\u898b\u76f4\u3057\u306e\u91cd\u8981\u6027\u304c\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002CT\u30d7\u30ed\u30c8\u30b3\u30eb\u3067SAP\u3092\u4f5c\u6210\u3059\u308b\u969b\u306b\u8003\u616e\u3059\u3079\u304d\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3092\u4ee5\u4e0b\u306b\u8a73\u8ff0\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u7d71\u8a08\u89e3\u6790\u306e\u8a73\u7d30<\/li>\n<li>\u30c6\u30af\u30cb\u30ab\u30eb\u5206\u6790\u306e\u4e3b\u306a\u7279\u5fb4\u3092\u8a73\u3057\u304f\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>\u8a66\u9a13\u306e\u76ee\u7684<\/li>\n<li>\u30c7\u30fc\u30bf\u30bd\u30fc\u30b9<\/li>\n<li>\u8abf\u67fb\u5bfe\u8c61\u8005<\/li>\n<li>\u8a66\u9a13\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8<\/li>\n<li>\u7d71\u8a08\u624b\u6cd5<\/li>\n<li>\u611f\u5ea6\u89e3\u6790\u3068\u6b20\u640d\u30c7\u30fc\u30bf<\/li>\n<\/ul>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306eSAP\u306f\u3001\u8a66\u9a13\u8cac\u4efb\u8005\u3068\u7d71\u8a08\u62c5\u5f53\u8005\u306e\u9593\u3067\u7dbf\u5bc6\u306a\u8a71\u3057\u5408\u3044\u3092\u3057\u306a\u304c\u3089\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4ee5\u4e0b\u306f\u3001\u7d71\u8a08\u62c5\u5f53\u8005\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3067\u3042\u308b\u3002<\/p>\n<ul>\n<li>\u3092\u66f8\u304f\u3053\u3068\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> statement or hypothesis of the clinical trial study.<\/li>\n<li>\u30d7\u30e9\u30a4\u30de\u30ea\u30fc\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3068\u30bb\u30ab\u30f3\u30c0\u30ea\u30fc\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3092\u6c7a\u5b9a\u3059\u308b\u3002<\/li>\n<li>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30d0\u30a4\u30a2\u30b9\u3068\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u306e\u9078\u629e\u3092\u6e1b\u3089\u3059\u305f\u3081\u306e\u6226\u7565\u3092\u898b\u3064\u3051\u51fa\u3057\u3001\u958b\u767a\u3059\u308b\u3002<\/li>\n<li>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u89e3\u6790\u306e\u305f\u3081\u306e\u9069\u5207\u306a\u7d71\u8a08\u624b\u6cd5\u3092\u3059\u3079\u3066\u5b9a\u7fa9\u3059\u308b\u3053\u3068<\/li>\n<\/ul>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308bSAP\u306e\u958b\u767a\u3067\u306f\u3001\u8a73\u7d30\u306a\u30ad\u30fc\u30cf\u30a4\u30e9\u30a4\u30c8\u30dd\u30a4\u30f3\u30c8\u3092\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002Yuan et al.2019\u3067\u306f\u3001\u7279\u96c6\u8a18\u4e8b\u3068\u3057\u3066\"<a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/abs\/10.1111\/pan.13576\">\u7d71\u8a08\u89e3\u6790\u30d7\u30e9\u30f3\u306e\u3054\u6848\u5185<\/a>\"[\u56f32]\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u306e\u8ad6\u6587\u3067\u306f\u3001\u5b9f\u969b\u306e\u81e8\u5e8a\u8a66\u9a13\u7814\u7a76\u306eSAP\u3092\u8a73\u7d30\u306b\u8aac\u660e\u3057\u3001\u52b9\u679c\u7684\u306aSAP\u3092\u66f8\u304f\u305f\u3081\u306e\u5b9f\u8df5\u7684\u306a\u8a73\u7d30\u30ac\u30a4\u30c9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u540c\u8ad6\u6587\u3067\u306f\u3001SAP\u306e\u3069\u3053\u306b\u3001\u4f55\u3092\u3001\u306a\u305c\u3001\u3044\u3064\u3001\u8ab0\u304c\u3001\u305d\u3057\u3066SAP\u306e\u91cd\u8981\u306a\u5185\u5bb9\u3092\u5f37\u8abf\u3059\u308b\u306e\u304b\u306b\u3064\u3044\u3066\u3082\u8ad6\u3058\u3066\u3044\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u7814\u7a76\u3067\u306f\u3001\u7279\u306b\u898f\u5236\u5f53\u5c40\u306e\u7814\u7a76\u306e\u305f\u3081\u306b\u3001\u3088\u304f\u66f8\u304b\u308c\u3001\u6587\u66f8\u5316\u3055\u308c\u305fSAP\u306e\u5fc5\u8981\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Importance_of_the_Statistical_Analysis_Plan_in_Clinical_Trials\"><\/span><strong>2.\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b\u306e\u91cd\u8981\u6027<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CT\u306f\u3001\u3059\u3079\u3066\u306e\u65b0\u3057\u3044\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u5b9f\u65bd\u3055\u308c\u307e\u3059\u3002\u3053\u306e10\u5e74\u9593\u3067\u3001\u533b\u85ac\u54c1\u958b\u767a\u306e\u305f\u3081\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u63a1\u7528\u3055\u308c\u308b\u60a3\u8005\u306e\u5272\u5408\u306f\u3001\u6b27\u7c73\u3060\u3051\u3067\u306a\u304f\u3001\u767a\u5c55\u9014\u4e0a\u56fd\u304b\u3089\u3082\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u3001SAP\u306f\u975e\u5e38\u306b\u91cd\u8981\u306a\u6587\u66f8\u306e\u4e00\u3064\u3067\u3059\u3002SAP\u306f\u3001\u4e8b\u524d\u306b\u8a08\u753b\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u8a66\u9a13\u4eee\u8aac\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u5206\u6790\u304c\u3001\u79d1\u5b66\u7684\u306b\u59a5\u5f53\u306a\u65b9\u6cd5\u3067\u5b9f\u65bd\u3055\u308c\u3001\u3059\u3079\u3066\u306e\u6c7a\u5b9a\u304c\u6587\u66f8\u5316\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u7d50\u679c\u3092\u3069\u306e\u3088\u3046\u306b\u767a\u8868\u3057\u3001CT\u3067\u5831\u544a\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u3082\u8a73\u7d30\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u533b\u7642\u30d8\u30eb\u30b9\u30b1\u30a2\u306b\u304a\u3051\u308b\u8ffd\u52a0\u7684\u306a\u5229\u76ca\u3092\u8a55\u4fa1\u3057\u3001\u4ecb\u5165\u3092\u6539\u5584\u3059\u308b\u305f\u3081\u306b\u884c\u308f\u308c\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u969b\u306b\u8003\u616e\u3059\u3079\u304d\u91cd\u8981\u306a\u70b9\u306f\u3001\u30d0\u30a4\u30a2\u30b9\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u3066\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u5404\u81e8\u5e8a\u8a66\u9a13\u3067\u306f\u3001\u518d\u73fe\u6027\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306e\u660e\u78ba\u3067\u8a73\u7d30\u306aSAP\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002CT\u79d1\u5b66\u7814\u7a76\u306e\u6700\u826f\u306e\u5b9f\u8df5\u3001\u7814\u7a76\u306e\u518d\u73fe\u6027\u3001\u305d\u3057\u3066\u81e8\u5e8a\u7814\u7a76\u306e\u60aa\u7528\u306e\u61f8\u5ff5\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u3068\u5831\u544a\u3092\u6539\u5584\u3059\u308b\u305f\u3081\u306b\u3001\u660e\u78ba\u3067\u8a73\u7d30\u306a\u3001\u975e\u5e38\u306b\u900f\u660e\u6027\u306e\u9ad8\u3044SAP\u304c\u5fc5\u8981\u3067\u3059\u3002\u4ee5\u4e0b\u306f\u3001CT\u3092\u5b9f\u65bd\u3059\u308b\u4e0a\u3067\u7dad\u6301\u3059\u3079\u304dSAP\u306e3\u3064\u306e\u91cd\u8981\u306a\u5f79\u5272\u3067\u3042\u308b\u3002<\/p>\n<ul>\n<li><strong>\u900f\u660e\u6027\u3002 <\/strong>\u9069\u7528\u3055\u308c\u308b\u624b\u6cd5\u3092\u4e8b\u524d\u306b\u660e\u793a\u3059\u308b\u3053\u3068\u3067\u3001\u5206\u6790\u306e\u9032\u3081\u65b9\u3092\u900f\u660e\u5316\u3059\u308b\u3053\u3068<\/li>\n<\/ul>\n<ul>\n<li><strong>\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3067\u3059\u3002 <\/strong>\u7814\u7a76\u306e\u9032\u3081\u65b9\u306b\u3064\u3044\u3066\u3001\u7814\u7a76\u306b\u95a2\u308f\u308b\u3059\u3079\u3066\u306e\u4eba\u306b\u660e\u78ba\u306b\u4f1d\u3048\u308b\u3053\u3068<\/li>\n<\/ul>\n<ul>\n<li><strong>\u30ec\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3067\u3059\u3002 <\/strong>\u8907\u88fd\u3092\u5bb9\u6613\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u5c06\u6765\u306e\u7814\u7a76\u30c1\u30fc\u30e0\u304c\u540c\u3058\u30b9\u30c6\u30c3\u30d7\u3092\u8e0f\u3093\u3067\u3001\u540c\u3058\u30b5\u30f3\u30d7\u30eb\u307e\u305f\u306f\u65b0\u3057\u3044\u30b5\u30f3\u30d7\u30eb\u3067\u7d50\u679c\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>\u6a19\u6e96\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306b\u5f93\u3063\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u7d71\u8a08\u62c5\u5f53\u8005\/\u751f\u7269\u7d71\u8a08\u62c5\u5f53\u8005\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u958b\u59cb\u524d\u306b\u3001\u8a08\u753b\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u5206\u6790\u3001\u5206\u6790\u30bb\u30c3\u30c8\u306e\u5b9a\u7fa9\u3092\u542b\u3080\u8a66\u9a13\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u57fa\u672c\u7684\/\u9ad8\u5ea6\u306a\u7d71\u8a08\u624b\u6cd5\u3092\u8a73\u7d30\u306b\u8a18\u8f09\u3057\u305f\u8a66\u9a13SAP\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n<p>\u307e\u305f\u3001CT\u306eSAP\u306b\u95a2\u9023\u3059\u308b\u305d\u306e\u4ed6\u306e\u91cd\u8981\u306a\u691c\u8a0e\u4e8b\u9805\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n<ul>\n<li>\u30d0\u30a4\u30a2\u30b9\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u65b9\u6cd5\u306e\u4e00\u3064\u3068\u3057\u3066\u3001Biostatistician\u306e\u76ee\u3092\u3064\u3076\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>SAP\u306f\u3001\u5b9f\u884c\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u64cd\u4f5c\u3068\u5206\u6790\u3092\u518d\u73fe\u3067\u304d\u308b\u3088\u3046\u306b\u6587\u66f8\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>Trial Master File\u306f\u3001Biostatistician\u306b\u3088\u3063\u3066\u3001\u8a66\u9a13\u7d42\u4e86\u6642\u306b\u3059\u3079\u3066\u306e\u95a2\u9023\u6587\u66f8\u3068\u3068\u3082\u306b\u7dad\u6301\u3055\u308c\u308b\u3053\u3068\u304c\u8981\u6c42\u3055\u308c\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>\u4f53\u7cfb\u7684\u306b\u914d\u7f6e\u3055\u308c\u305f\u5206\u6790\u8a08\u753b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u304c\u4e00\u7dd2\u306b\u540c\u3058\u30da\u30fc\u30b8\u3092\u898b\u3066\u3044\u308b\u3053\u3068\u3092\u52a9\u3051\u3001CT\u306b\u3082\u3046\u4e00\u3064\u306e\u5177\u4f53\u6027\u3092\u52a0\u3048\u307e\u3059\u3002SAP\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u7814\u7a76\u306e\u4f53\u7cfb\u7684\u306b\u8a08\u753b\u3055\u308c\u305f\u7d71\u8a08\u624b\u6cd5\u3092\u8a18\u8ff0\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u3002\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u6bd4\u8f03\u3057\u3066\u3001SAP\u306f\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3068\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u5206\u6790\u306e\u305f\u3081\u306e\u8a73\u7d30\u306a\u7d71\u8a08\u624b\u6cd5\u3092\u8a18\u8f09\u3057\u305f\u8a73\u7d30\u306a\u6280\u8853\u6587\u66f8\u3067\u3059\u3002SAP\u3092\u4f5c\u6210\u3059\u308b\u969b\u306b\u306f\u3001\u4e00\u822c\u7684\u306bICH E3\u304a\u3088\u3073E9\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001SAP\u306e\u5404\u30bb\u30af\u30b7\u30e7\u30f3\u306e\u5185\u5bb9\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3057\u304b\u3057\u3001E3\u3068E9\u306b\u306f\u7279\u5b9a\u306e\u7d71\u8a08\u624b\u6cd5\u306f\u660e\u8a18\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u518d\u73fe\u6027\u3001\u900f\u660e\u6027\u3001\u59a5\u5f53\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306b\u7c73\u56fd\u56fd\u7acb\u885b\u751f\u7814\u7a76\u6240(<a href=\"https:\/\/www.federalregister.gov\/documents\/2016\/09\/21\/2016%20-22129\/clinical%20-trials%20-registration%20-and%20-%20results%20-information%20\u2013submission\">NIH<\/a>)\u306f\u3001\u300c\u81e8\u5e8a\u8a66\u9a13\u306e\u767b\u9332\u304a\u3088\u3073\u7d50\u679c\u60c5\u5831\u306e\u63d0\u51fa\u306b\u95a2\u3059\u308b\u898f\u5247\u300d\u3092\u767a\u8868\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u767b\u9332\u3001ClinicalTrials.gov\u3078\u306e\u81e8\u5e8a\u8a66\u9a13\u4e2d\u306e\u52df\u96c6\u3084\u7d50\u679c\u306e\u63b2\u8f09\u3001\u81e8\u5e8a\u8a66\u9a13\u7814\u7a76\u8a08\u753b\u66f8\u3068\u306f\u5225\u306e\u30aa\u30ea\u30b8\u30ca\u30eb\u6587\u66f8\u3067\u3042\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b\u66f8(SAP)\u306e\u63d0\u51fa\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u533b\u7642\u7d71\u8a08\u5bb6\/\u751f\u7269\u7d71\u8a08\u5bb6\u306e\u5927\u304d\u306a\u8ca2\u732e\u306f\u3001\u6a19\u6e96\u7684\u306aSAP\u306e\u958b\u767a\u306e\u4ed6\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u8a2d\u8a08\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u5206\u6790\u306b\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Detailed_checklistguidelines_for_SAPs_in_clinical_trials\"><\/span><strong>3.\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308bSAP\u306e\u8a73\u7d30\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\/\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CT\u306eSAP\u3092\u958b\u767a\u3059\u308b\u969b\u306b\u306f\u3001\u8a73\u7d30\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3084\u6a19\u6e96\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u3059\u3079\u3066\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002SAP\u306e\u958b\u767a\u306b\u4f7f\u7528\u3055\u308c\u308b\u91cd\u8981\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001ICH E9\uff08International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use\uff09\u304a\u3088\u3073SPIRIT\uff08Standard Protocol Items: Recommendations for Interventional Trials\uff09\u3067\u3042\u308b\u3002<\/p>\n<p>\u900f\u660e\u6027\u3068\u518d\u73fe\u6027\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u4fa1\u5024\u3092\u9ad8\u3081\u308b\u57fa\u672c\u7684\u306a\u7528\u8a9e\u3067\u3042\u308b\u3002\u3057\u304b\u3057\u3001\u7d71\u8a08\u7684\u624b\u6cd5\u306e\u5f71\u97ff\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u610f\u601d\u6c7a\u5b9a\u306b\u76f4\u63a5\u5f71\u97ff\u3059\u308b\u305f\u3081\u3001\u6587\u66f8\u5316\u3055\u308c\u3001\u6a5f\u5bc6\u6027\u304c\u4fdd\u305f\u308c\u3001\u900f\u660e\u6027\u306e\u3042\u308b\u7d71\u8a08\u7684\u884c\u70ba\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u5c02\u9580\u5bb6\u3067\u3042\u308b\u533b\u5b66\u7d71\u8a08\u5b66\u8005\/\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306f\u3001\u6a19\u6e96\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6cbf\u3063\u305fSAP\u306e\u958b\u767a\u3092\u652f\u63f4\u3057\u307e\u3059\u3002<\/p>\n<p>ICH E9\u3067\u306f\u3001SAP\u306f\u901a\u5e38\u5831\u544a\u5206\u6790\u8a08\u753b\u3068\u3057\u3066\u77e5\u3089\u308c\u3066\u3044\u308b\u304c\u3001\u4ed6\u306e\u7d44\u7e54\u3067\u306f\u30c7\u30fc\u30bf\u5206\u6790\u8a08\u753b\uff08DAP\uff09\u307e\u305f\u306f\u7d71\u8a08\u5206\u6790\u8a08\u753b\uff08SAP\uff09\u3068\u547c\u3070\u308c\u308b\u3053\u3068\u3082\u3042\u308b\u3002ICH E9\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\"\u6700\u7d42\u7684\u306a\u30c7\u30fc\u30bf\u306eSAP\u306e\u4e3b\u306a\u7279\u5fb4\u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u7d71\u8a08\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u8a18\u8f09\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b \"\u3068\u3055\u308c\u3066\u3044\u308b\u3002\u3057\u304b\u3057\u3001SPIRIT\uff08Standard Protocol Items: Recommendations for Interventional Trials\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u5225\u500b\u306eSAP\u306b\u3064\u3044\u3066\u8a00\u53ca\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>SAP\u306f\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u5831\u544a\u304c\u5fc5\u8981\u306aCT\u306b\u304a\u3044\u3066\u3001\u6700\u3082\u91cd\u8981\u306a\u6587\u66f8\u3067\u3059\u3002<a href=\"https:\/\/www.fda.gov\/home\">FDA<\/a>)\u3001\u6b27\u5dde\u533b\u85ac\u54c1\u5e81(European Medicines Agency)<a href=\"https:\/\/www.ema.europa.eu\/en\">EMA<\/a>)).\u6a19\u6e96\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001SAP\u306f\u6a5f\u5bc6\u6027\u306e\u9ad8\u3044\u81e8\u5e8a\u8a66\u9a13\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u5b58\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u3055\u308c\u3066\u304a\u308a\u3001\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u76e3\u67fb\u306e\u969b\u306b\u3001\u7d71\u8a08\u6587\u66f8\u304c\u6a19\u6e96\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6b63\u78ba\u306b\u5f93\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>SAP\u306f\u3001\u7d71\u8a08\u5bb6\u3092\u6307\u5c0e\u3059\u308b\u305f\u3081\u306e\u6700\u3082\u4e00\u822c\u7684\u306a\u6587\u66f8\u3067\u3042\u308b\u3002\u4e00\u822c\u7684\u306b\u3001SAP\u306b\u306f\u4ee5\u4e0b\u306e\u9805\u76ee\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff08\u56f33\uff09\u3002<\/p>\n<p>\u7d71\u8a08\u62c5\u5f53\u8005\u3092\u7d39\u4ecb\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<a href=\"http:\/\/www.consort-statement.org\/\">\u306e\u3067\u3059\u3002\u00a0<\/a> <a href=\"http:\/\/www.consort-statement.org\/\">CONSORT\u58f0\u660e<\/a> (\u304a\u3088\u3073\u4efb\u610f\u306e\u62e1\u5f35\u5b50)\u3001\u3055\u3089\u306b\u00a0<a href=\"http:\/\/www.emea.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500002928.pdf\">ICH E9 \u81e8\u5e8a\u8a66\u9a13\u306e\u7d71\u8a08\u7684\u539f\u5247 (PDF, 325 KB)<\/a>.<\/p>\n<ul>\n<li><a href=\"https:\/\/www.ct-toolkit.ac.uk\/routemap\/trial-planning-and-design\/\">\u30c8\u30e9\u30a4\u30a2\u30eb\u30d7\u30e9\u30f3\u30cb\u30f3\u30b0\uff06\u30c7\u30b6\u30a4\u30f3\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3<\/a><\/li>\n<li><a href=\"http:\/\/www.equator-network.org\/\">EQUATOR\u30cd\u30c3\u30c8\u30ef\u30fc\u30af<\/a>- \u5065\u5eb7\u8abf\u67fb\u7814\u7a76\u306e\u512a\u308c\u305f\u5831\u544a\u306e\u305f\u3081\u306e\u30ea\u30bd\u30fc\u30b9\u30bb\u30f3\u30bf\u30fc\u3067\u3059\u3002<\/li>\n<li><a href=\"http:\/\/www.consort-statement.org\/\">CONSORT\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8<\/a><\/li>\n<li>2017\u5e74\u306b\u767a\u8868\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2666509\">Gamble et al<\/a>.2017\u5e74\u3001\u3053\u308c\u3089\u306e\u8ad6\u6587\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001SAP\u306e\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u3092\u5c55\u958b\u3059\u308b\u969b\u306b\u8003\u616e\u3059\u3079\u304d\u91cd\u8981\u306a\u9805\u76ee\u3068\u3057\u3066\u3001\u6700\u4f4e55\u9805\u76ee\u3092\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>\u30bf\u30a4\u30c8\u30eb\u3068\u767b\u9332<\/li>\n<li>\u306f\u3058\u3081\u306b<\/li>\n<li>\u8abf\u67fb\u65b9\u6cd5<\/li>\n<li>\u7d71\u8a08\u7684\u539f\u7406<\/li>\n<li>\u8a66\u9a13\u5bfe\u8c61\u8005<\/li>\n<li>\u5206\u6790<\/li>\n<\/ul>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8741\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap4.jpg\" alt=\"\" width=\"422\" height=\"365\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap4.jpg 780w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap4-300x259.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap4-768x663.jpg 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap4-110x96.jpg 110w\" sizes=\"(max-width: 422px) 100vw, 422px\" \/><\/p>\n<p><strong>\u56f33\uff0e \u00a0<\/strong><a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2666509\">Gamble et al<\/a><strong>.2017\u5e74\u7248\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u5927\u304d\u304f6\u3064\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u5206\u304b\u308c\u3066\u3044\u307e\u3059\u3002 <\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_What_does_an_SAP_consist_of\"><\/span>4.SAP\u306f\u4f55\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u308b\u306e\u3067\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A\u00a0<a href=\"https:\/\/lctc.org.uk\/Content\/SAP%202019%20Checklist.docx\">\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a>\u00a0\u3092\u958b\u767a\u3059\u308b\u305f\u3081\u306e32\u306e\u8a73\u7d30\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e <a href=\"http:\/\/lctc.org.uk\/Content\/SAP%202019%20Checklist.docx\">\u7d71\u8a08\u89e3\u6790\u8a08\u753b(SAP)\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8(Word)<\/a>.\u5f8c\u671f\u7121\u4f5c\u70ba\u5316CT\u3060\u3051\u3067\u306a\u304f\u3001CT\u306e\u6700\u7d42\u89e3\u6790\u306b\u3082\u3088\u308a\u9069\u7528\u3067\u304d\u308b\u3053\u3068\u3092\u7b2c\u4e00\u306e\u610f\u56f3\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u304c\u4f5c\u6210\u3057\u305f\u6700\u3082\u91cd\u8981\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001FDA\u306e\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/e9-statistical-principles-clinical-trials\">\u30ac\u30a4\u30c0\u30f3\u30b9\u30fb\u30d5\u30a9\u30fc\u30fb\u30a4\u30f3\u30c0\u30b9\u30c8\u30ea\u30fc\u81e8\u5e8a\u8a66\u9a13\u306e\u7d71\u8a08\u7684\u539f\u5247<\/a>.<\/p>\n<p>SAP\u306e\u5185\u5bb9\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u63a8\u5968\u4e8b\u9805\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>SAP\u306f\u5358\u72ec\u306e\u6587\u66f8\u3067\u306f\u306a\u304f\u3001\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u4f75\u305b\u3066\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002<\/li>\n<li>\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u4ee5\u4e0b\u306e\u539f\u5247\u306b\u6cbf\u3063\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u00a0<a href=\"https:\/\/www.spirit-statement.org\/\">SPIRIT 2013\u5e74\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8<\/a>.<\/li>\n<li>SAP\u306f\u3001\u5206\u6790\u306e\u305f\u3081\u306e\u30af\u30ea\u30fc\u30f3\u306a\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u307e\u305f\u306f\u691c\u8a3c\u6e08\u307f\u306e\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>\u8cc7\u91d1\u63d0\u4f9b\u8005\u3001\u898f\u5236\u5f53\u5c40\u3001\u30b8\u30e3\u30fc\u30ca\u30eb\u3001\u696d\u754c\u306e\u4ee3\u8868\u8005\u3068\u306e\u9593\u3067\u4f5c\u6210\u3055\u308c\u305f\u8a73\u7d30\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3002\u00a0<a href=\"https:\/\/www.ukcrc-ctu.org.uk\/\">UK\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30ea\u30b5\u30fc\u30c1\u30fb\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u767b\u9332\u81e8\u5e8a\u8a66\u9a13\u30e6\u30cb\u30c3\u30c8<\/a>\u00a0(UKCRC CTU)\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002The Guidelines for the Content of Statistical Analysis Plans in Clinical Trials\uff08\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u7d71\u8a08\u89e3\u6790\u8a08\u753b\u306e\u5185\u5bb9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u306e\u8a73\u7d30\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002\u00a0<a href=\"https:\/\/doi.org\/10.1001\/jama.2017.18556\">JAMA<\/a>.\u305f\u3060\u3057\u3001\u5404\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u9805\u76ee\u3054\u3068\u306e\u3088\u308a\u8a73\u7d30\u306a\u8a73\u7d30\u8aac\u660e\u306f\u00a0<a href=\"https:\/\/lctc.org.uk\/Content\/SAP%20Statement_%20Elaboration%20Document%20v1.0.pdf\">\u63a8\u6572\u8cc7\u6599<\/a>.\u307e\u305f\u3001SAP\u306e\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3082\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<a href=\"https:\/\/www.equator-network.org\/reporting-guidelines\/guidelines-for-the-content-of-statistical-analysis-plans-in-clinical-trials\/\">\u30a8\u30af\u30a8\u30fc\u30bf\u30fc\u30cd\u30c3\u30c8\u30ef\u30fc\u30af<\/a> \u305d\u3057\u3066 <a href=\"https:\/\/www.methodologyhubs.mrc.ac.uk\/about\/tmrp\">MRC-NIHR \u30c8\u30e9\u30a4\u30a2\u30eb\u65b9\u6cd5\u8ad6\u7814\u7a76\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\uff08TMRP<\/a>.\u4ee5\u4e0b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3067SAP\u3092\u958b\u767a\u3059\u308b\u969b\u306b\u4f7f\u7528\u3055\u308c\u305f\u4e3b\u8981\u6587\u66f8\u3068\u4e3b\u8981\u30ea\u30f3\u30af\u3067\u3059\uff08\u56f34\uff09\u3002<\/p>\n<ul>\n<li><strong>\u30ad\u30fc\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8 <\/strong>\n<ul>\n<li>\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/li>\n<li>\u7cbe\u7dfb\u5316<\/li>\n<li>JAMA\u8ad6\u6587<\/li>\n<li><strong>\u4e3b\u306a\u30ea\u30f3\u30af<\/strong>\n<ul>\n<li><a href=\"https:\/\/www.equator-network.org\/reporting-guidelines\/guidelines-for-the-content-of-statistical-analysis-plans-in-clinical-trials\/\">\u30a8\u30af\u30a8\u30fc\u30bf\u30fc\u30cd\u30c3\u30c8\u30ef\u30fc\u30af<\/a><\/li>\n<li><a href=\"https:\/\/www.methodologyhubs.mrc.ac.uk\/about\/tmrp\">MRC-NIHR \u30c8\u30e9\u30a4\u30a2\u30eb\u65b9\u6cd5\u8ad6\u7814\u7a76\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\uff08TMRP<\/a><\/li>\n<li><a href=\"https:\/\/www.ukcrc-ctu.org.uk\/\">UK\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30ea\u30b5\u30fc\u30c1\u30fb\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u767b\u9332\u81e8\u5e8a\u8a66\u9a13\u30e6\u30cb\u30c3\u30c8<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8742\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap5.jpg\" alt=\"\" width=\"593\" height=\"273\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap5.jpg 780w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap5-300x138.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/01\/sap5-768x353.jpg 768w\" sizes=\"(max-width: 593px) 100vw, 593px\" \/><\/p>\n<p><strong>\u56f34\uff1a\u81e8\u5e8a\u8a66\u9a13\u3067SAP\u3092\u958b\u767a\u3059\u308b\u969b\u306b\u4f7f\u7528\u3057\u305f\u4e3b\u8981\u6587\u66f8\u3068\u4e3b\u8981\u30ea\u30f3\u30af<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Hiring_a_freelance_clinical_statistician_for_help_with_SAPs\"><\/span>5.\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u7d71\u8a08\u5bb6\u3092\u96c7\u3063\u3066SAP\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u3057\u3066\u3082\u3089\u3046<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>SAP\u306e\u958b\u767a\u306b\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u7d71\u8a08\u5bb6\u306e\u30b5\u30dd\u30fc\u30c8\u304c\u5fc5\u8981\u3067\u3059\u3002\u7d4c\u9a13\u8c4a\u5bcc\u306a\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306e\u52a9\u3051\u3092\u501f\u308a\u308c\u3070\u3001\u5b8c\u5168\u3067\u30a8\u30e9\u30fc\u306e\u306a\u3044SAP\u3092\u958b\u767a\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u8cea\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><strong>\u95b2\u89a7 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=SAP\">\u81e8\u5e8a\u8a66\u9a13\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u4eca\u3059\u3050Kolabtree\u306b\u30a2\u30af\u30bb\u30b9\u3057\u3066\u3001\u5c02\u9580\u5bb6\u3068\u76f4\u63a5\u9023\u7d61\u3092\u53d6\u3063\u3066\u307f\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Kolabtree freelance biostatistician consultant, Rudra Patel provides a comprehensive guide on how to develop a Statistical Analysis Plan (SAP) for Clinical Trials. \u00a0\u00a0 1. Statistical Analysis Plan (SAP) in a Clinical Trial (CT) A well-written and complete Statistical Analysis Plan (SAP) is important to increase the quality of clinical trials and make it more valid and generalized. \u201cPlanning is bringing the future into the present so that you can do something about it now\u201d \u00a0&#8211; Alan Lakein. SAP is a defined outline of the planned statistical basic\/advance methods for the analyses for a clinical trial and is written in study protocol as well as separately.\u00a0 SAP is crucial and is<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8764,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,435],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How to Develop a Statistical Analysis Plan (SAP) For Clinical Trials<\/title>\n<meta name=\"description\" content=\"An expert&#039;s guide to writing a statistician analysis plan (SAP) for clinical trials. Includes overall structure and detailed checklist.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Develop a Statistical Analysis Plan (SAP) For Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"An expert&#039;s guide to writing a statistician analysis plan (SAP) for clinical trials. Includes overall structure and detailed checklist.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2021-02-08T12:30:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-14T07:12:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/02\/Statistical-Analysis-Plan-Clinical-Trials.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"782\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"9\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How to Develop a Statistical Analysis Plan (SAP) For Clinical Trials","description":"An expert's guide to writing a statistician analysis plan (SAP) for clinical trials. 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