{"id":5793,"date":"2019-07-30T10:22:32","date_gmt":"2019-07-30T10:22:32","guid":{"rendered":"https:\/\/blog.kolabtree.com\/?p=5793"},"modified":"2022-01-06T14:01:52","modified_gmt":"2022-01-06T14:01:52","slug":"how-freelance-statisticians-can-improve-research","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/how-freelance-statisticians-can-improve-research\/","title":{"rendered":"\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5bb6\u304c\u7814\u7a76\u3092\u6539\u5584\u3059\u308b\u65b9\u6cd5"},"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-69f33dd75e5d6\" 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-69f33dd75e5d6\"><\/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-freelance-statisticians-can-improve-research\/#1_Clinical_Trial_Design\" title=\"1.\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\">1.\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3<\/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-freelance-statisticians-can-improve-research\/#2_Regulatory_Planning\" title=\"2.\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30d7\u30e9\u30f3\u30cb\u30f3\u30b0\">2.\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30d7\u30e9\u30f3\u30cb\u30f3\u30b0<\/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-freelance-statisticians-can-improve-research\/#3_Risk_Monitoring\" title=\"3.\u30ea\u30b9\u30af\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\">3.\u30ea\u30b9\u30af\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/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-freelance-statisticians-can-improve-research\/#4_Effective_Communication_of_Results\" title=\"4.\u7d50\u679c\u306e\u52b9\u679c\u7684\u306a\u4f1d\u9054\">4.\u7d50\u679c\u306e\u52b9\u679c\u7684\u306a\u4f1d\u9054<\/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-freelance-statisticians-can-improve-research\/#5_Finalization_of_Clinical_Study_Report_NDA_Preparation\" title=\"5.\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u6700\u7d42\u4f5c\u6210\u3068NDA\u306e\u6e96\u5099\">5.\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u6700\u7d42\u4f5c\u6210\u3068NDA\u306e\u6e96\u5099<\/a><\/li><\/ul><\/nav><\/div>\n<p>\u3068\u3044\u3046\u7a7a\u524d\u306e\u9700\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/services\/statistical-analysis\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Freelance-Statisticians-Research\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5bb6<\/a>\u00a0\u3067 <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>, especially in clinical research, However, as the progress towards real-world data &amp; real-world evidence continues, there is more and more emphasis on how a statistician\u2019s expertise cannot be limited to just the knowledge of statistical methods.<\/p>\n<p>\u516c\u8846\u885b\u751f\u3084\u75ab\u5b66\u306e\u7814\u7a76\u306f\u6025\u901f\u306b\u767a\u5c55\u3057\u3066\u304a\u308a\u3001\u79d1\u5b66\u8005\u305f\u3061\u306f\u81e8\u5e8a\u8a66\u9a13\u3092\u30c7\u30b6\u30a4\u30f3\u3057\u3001\u3088\u308a\u826f\u3044\u7814\u7a76\u7d50\u679c\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5bb6\u3092\u96c7\u3046\u3053\u3068\u3092\u9078\u629e\u3057\u3066\u3044\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u306f\u3001\u7d71\u8a08\u5bb6\u306f\u3088\u308a\u591a\u304f\u306e\u60c5\u5831\u3092\u5f97\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<a href=\"https:\/\/www.nature.com\/articles\/d41586-019-02084-8\">\u5b9f\u9a13\u306b\u3055\u3089\u3055\u308c\u308b<\/a>.<\/p>\n<p>\u81e8\u5e8a\u7814\u7a76\u306b\u643a\u308f\u3063\u3066\u3044\u308b\u9593\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5bb6\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u76ee\u7684\u3092\u5185\u5305\u3057\u3001\u3055\u307e\u3056\u307e\u306a\u5f62\u5f0f\u306e\u30c7\u30fc\u30bf\u3092\u4fdd\u5b58\u3057\u3001\u30c7\u30fc\u30bf\u306e\u9650\u754c\u306b\u3064\u3044\u3066\u6307\u5c0e\u3057\u3001\u6700\u5f8c\u306b\u53ce\u96c6\u3057\u305f\u30c7\u30fc\u30bf\u306e\u5206\u6790\u3092\u884c\u3046\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u81e8\u5e8a\u7d71\u8a08\u5bb6\u306f\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u7406\u89e3\u3059\u308b\u4e0a\u3067\u5927\u304d\u306a\u5f79\u5272\u3092\u62c5\u3063\u3066\u304a\u308a\u3001\u6700\u3082\u91cd\u8981\u306a\u306e\u306f\u3001\u898f\u5236\u5f53\u5c40\u3084\u696d\u754c\u5168\u4f53\u306b\u7d50\u679c\u3092\u63d0\u793a\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n<p>\u3053\u3053\u3067\u306f\u3001\u81e8\u5e8a\u958b\u767a\u3084\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u3055\u307e\u3056\u307e\u306a\u6bb5\u968e\u306b\u304a\u3051\u308b\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5bb6\u306e\u5f79\u5272\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Clinical_Trial_Design\"><\/span>1.\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6cbb\u7642\u88fd\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u306f\u3001\u7b2cI\u76f8\u3001\u7b2cII\u76f8\u3001\u7b2cIII\u76f8\u3001\u7b2cIV\u76f8\u306e4\u3064\u306e\u30d5\u30a7\u30fc\u30ba\u304c\u3042\u308a\u307e\u3059\u3002\u5f93\u6765\u3001\u7b2cI\u76f8\u3068\u7b2cII\u76f8\u306f\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u7d50\u8ad6\u304c\u51fa\u306a\u3044\u3068\u8003\u3048\u3089\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u6642\u4ee3\u306f\u5909\u5316\u3057\u3066\u304a\u308a\u3001\u521d\u671f\u306e\u6bb5\u968e\u3067\u751f\u7269\u7d71\u8a08\u5b66\u7684\u5206\u6790\u3092\u53ce\u96c6\u3059\u308b\u3053\u3068\u306f\u3001\u5f8c\u671f\u306e\u6bb5\u968e\u3067\u5b9f\u9a13\u306e\u7cbe\u5ea6\u3068\u901f\u5ea6\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306e\u6709\u52b9\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u3057\u3066\u8003\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u30d5\u30a7\u30fc\u30baI\u3068\u30d5\u30a7\u30fc\u30baII\u306e\u7d50\u679c\u3092\u8a73\u7d30\u306b\u751f\u7269\u7d71\u8a08\u5b66\u7684\u306b\u5206\u6790\u3057\u305f\u7d50\u679c\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u306b\u6700\u3082\u91cd\u8981\u3068\u8003\u3048\u3089\u308c\u308b\u30d5\u30a7\u30fc\u30baIII\u306b\u5fc5\u8981\u306a\u7cbe\u5ea6\u3092\u9054\u6210\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u79d1\u5b66\u8005\u306f\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5b66\u8005\u3068\u30c1\u30fc\u30e0\u3092\u7d44\u307f\u3001\u7b2c3\u76f8\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u884c\u3046\u524d\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u30d7\u30ed\u30bb\u30b9\u306b\u5f7c\u3089\u3092\u53c2\u52a0\u3055\u305b\u308b\u306e\u304c\u826f\u3044\u6bb5\u968e\u3067\u3059\u3002<\/p>\n<p>A <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Freelance-Statisticians-Research\"><strong>\u30d0\u30a4\u30aa\u30b9\u30bf\u30c6\u30a3\u30b7\u30e3\u30f3<\/strong><\/a> \u306f\u3001\u81e8\u5e8a\u958b\u767a\u306e5\u3064\u306e\u30b9\u30c6\u30c3\u30d7\uff08\u69cb\u60f3\u3001\u8a2d\u8a08\u3001\u5b9f\u65bd\u3001\u5206\u6790\u3001\u88ab\u9a13\u8005\u306e\u85ac\u7269\u6d3b\u52d5\u60c5\u5831\u306e\u5831\u544a\uff09\u3092\u901a\u3058\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u7d71\u8a08\u7684\u306b\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\u69cb\u60f3\u306e\u6bb5\u968e\u3067\u306f\u3001\u751f\u7269\u7d71\u8a08\u5bb6\u306f\u6cbb\u7642\u9069\u5fdc\u75c7\u306b\u5fdc\u3058\u305f\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u3092\u63a8\u5b9a\u3057\u3001\u305d\u308c\u306b\u5fdc\u3058\u3066\u7d44\u307f\u5165\u308c\u57fa\u6e96\u3092\u6c7a\u5b9a\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306f\u3001\u30c7\u30fc\u30bf\u306e\u7121\u4f5c\u70ba\u5316\u3084\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u8a18\u9332\u3059\u308b\u305f\u3081\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u306e\u8a2d\u5b9a\u306a\u3069\u3067\u7814\u7a76\u8005\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u3067\u3001\u6b63\u78ba\u306a\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u5b8c\u5168\u306b\u6587\u66f8\u5316\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>\u3092\u96c7\u3046\u306e\u304c\u4e00\u822c\u7684\u306b\u306a\u3063\u3066\u304d\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Freelance-Statisticians-Research\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u751f\u7269\u7d71\u8a08\u5b66\u8005<\/a> \u306f\u3001\u3042\u308b\u7279\u5b9a\u306e\u533b\u85ac\u54c1\u3084\u9069\u5fdc\u75c7\u306b\u95a2\u3059\u308b\u3059\u3079\u3066\u306e\u7d71\u8a08\u4f5c\u696d\u3092\u88fd\u85ac\u696d\u754c\u3067\u884c\u3063\u3066\u304d\u307e\u3057\u305f\u3002\u3053\u306e\u3088\u3046\u306a\u7d4c\u9a13\u8c4a\u5bcc\u306a\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u4e88\u7b97\u914d\u5206\u3084\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306b\u57fa\u3065\u3044\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u4e2d\u9593\u5831\u544a\u4f1a\u306e\u5b9f\u65bd\u3084\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u306e\u8a55\u4fa1\u306a\u3069\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/p>\n<p>\u7d71\u8a08\u62c5\u5f53\u8005\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\uff08\u4e00\u6b21\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001\u4e8c\u6b21\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001\u30b5\u30ed\u30b2\u30fc\u30c8\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306e\u3044\u305a\u308c\u306b\u3059\u3079\u304d\u304b\uff09\u3001\u8a66\u9a13\u306e\u4e2d\u9593\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u6c7a\u5b9a\u3059\u308b\u4f1a\u8b70\u306b\u53c2\u52a0\u3057\u3001\u8a66\u9a13\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3082\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u30c7\u30fc\u30bf\u306b\u9069\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3084\u7d71\u8a08\u624b\u6cd5\u3092\u9078\u629e\u3057\u305f\u308a\u3001\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30a8\u30e9\u30fc\u306e\u57fa\u6e96\u3092\u6c7a\u5b9a\u3057\u305f\u308a\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Regulatory_Planning\"><\/span>2.\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30d7\u30e9\u30f3\u30cb\u30f3\u30b0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u7d71\u8a08\u5bb6\u306f\u3001FDA\u3001EMA\u3001MHRA\u3001CFDA\u3001TGA\u3001ICH\u3001WHO\u306a\u3069\u306e\u898f\u5236\u6a5f\u95a2\u304c\u767a\u884c\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3063\u3066\u3001\u8a66\u9a13\u76e3\u7763\u8005\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3001\u8a66\u9a13\u76e3\u8996\u59d4\u54e1\u4f1a\u3068\u5bc6\u63a5\u306b\u9023\u643a\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e-3-structure-content-clinical-study-reports-step-5_en.pdf\">\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8<\/a> \u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u30d1\u30e9\u30e1\u30fc\u30bf\u306b\u5f93\u3063\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u8a08\u753b\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u3001\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u63d0\u4f9b\u3055\u308c\u308b\u3002\u81e8\u5e8a\u8a66\u9a13\u3092\u8a08\u753b\u3059\u308b\u969b\u306b\u53c2\u7167\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306f\u3001\u6700\u65b0\u306e\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u76ee\u7684\u3092\u52b9\u679c\u7684\u306b\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u5341\u5206\u306b\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a66\u9a13\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u59d4\u54e1\u4f1a\u304c\u85ac\u4e8b\u6226\u7565\u3092\u7acb\u6848\u3059\u308b\u969b\u306e\u57fa\u790e\u8cc7\u6599\u3068\u306a\u308a\u307e\u3059\u3002\u751f\u7269\u7d71\u8a08\u5bb6\u304c\u3053\u308c\u3089\u306e\u30b9\u30c6\u30c3\u30d7\u306b\u95a2\u4e0e\u3057\u3001\u5f8c\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3067\u4e0d\u53ef\u6b20\u3068\u306a\u308b\u6709\u52b9\u6027\u3068\u5b89\u5168\u6027\u306e\u30c7\u30fc\u30bf\u306e\u5206\u6790\u306b\u53d6\u308a\u7d44\u3080\u4f59\u5730\u306f\u975e\u5e38\u306b\u5927\u304d\u3044\u3002<\/p>\n<p>\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u30bd\u30d5\u30c8\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/spss?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Freelance-Statisticians-Research\">SPSS<\/a> \u3068SAS\u3092\u4f7f\u3063\u3066\u3001\u8aa4\u5dee\u304c\u751f\u3058\u3084\u3059\u3044\u30c6\u30b9\u30c8\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3001\u305d\u308c\u3092\u9632\u3050\u305f\u3081\u306e\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u8003\u6848\u3057\u307e\u3059\u3002SPSS\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u7d71\u8a08\u5b66\u8005\u304c\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.hindawi.com\/journals\/jbe\/2014\/298140\/\">\u89e3\u8aad\u3059\u308b\u533b\u5e2b<\/a> \u81a8\u5927\u306a\u91cf\u306e\u75ab\u5b66\u30c7\u30fc\u30bf\u3084\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u60a3\u8005\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3092\u884c\u3044\u307e\u3059\u3002\u591a\u304f\u306e\u81e8\u5e8a\u7d71\u8a08\u5b66\u8005\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u5206\u6790\u306b\u3088\u304f\u4f7f\u308f\u308c\u308b\u50be\u5411\u30b9\u30b3\u30a2\u30de\u30c3\u30c1\u30f3\u30b0\u309295% CI\uff08\u4fe1\u983c\u533a\u9593\uff09\u3067\u5b9f\u884c\u3059\u308bR\u3092\u597d\u3093\u3067\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Risk_Monitoring\"><\/span>3.\u30ea\u30b9\u30af\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a13\u3067\u306f\u3001\u3042\u3089\u3086\u308b\u6bb5\u968e\u3067\u30a8\u30e9\u30fc\u304c\u767a\u751f\u3059\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u304f\u3001\u7279\u306b\u4f55\u5e74\u3082\u304b\u3051\u3066\u884c\u308f\u308c\u308b\u305f\u3081\u3001\u305d\u306e\u53ef\u80fd\u6027\u306f\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u59d4\u54e1\u4f1a\u304c\u3001\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306e\u30c1\u30fc\u30e0\u304c\u81e8\u5e8a\u8a66\u9a13\u306e\u6b63\u5e38\u306a\u6a5f\u80fd\u306b\u95a2\u4e0e\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308c\u3070\u3001\u30a8\u30e9\u30fc\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002\u81e8\u5e8a\u7d71\u8a08\u5b66\u8005\u306e\u30c1\u30fc\u30e0\u306f\u3001\u53ce\u96c6\u3055\u308c\u305f\u30c7\u30fc\u30bf\u304c\u30c7\u30fc\u30bf\u306e\u6b63\u5e38\u306a\u5206\u5e03\u3092\u793a\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u30c7\u30fc\u30bf\u306e\u5206\u5e03\u304c\u518d\u73fe\u53ef\u80fd\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b\u3053\u3068\u3067\u3001\u7cbe\u5bc6\u3067\u6b63\u78ba\u306a\u30c7\u30fc\u30bf\u53ce\u96c6\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002\u8aa4\u3063\u305f\u30c7\u30fc\u30bf\u304c\u767a\u898b\u3055\u308c\u305f\u5834\u5408\u3001\u8a66\u9a13\u76e3\u8996\u59d4\u54e1\u4f1a\u306f\u52b9\u679c\u7684\u306b\u610f\u601d\u6c7a\u5b9a\u3092\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u3001\u66d6\u6627\u306a\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u3092\u9632\u3050\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u7d71\u8a08\u62c5\u5f53\u8005\u306f\u3001\u898f\u5236\u62c5\u5f53\u30c1\u30fc\u30e0\u3084\u81e8\u5e8a\u6587\u66f8\u4f5c\u6210\u62c5\u5f53\u8005\u306b\u63d0\u51fa\u3059\u308b\u524d\u306b\u3001\u30c7\u30fc\u30bf\u306e\u5909\u52d5\u6027\u3084\u5206\u6790\u306e\u6b63\u78ba\u6027\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b\u4e3b\u8981\u306a\u8cac\u4efb\u3092\u8ca0\u3063\u3066\u3044\u308b\u3002<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u308f\u308b\u7d71\u8a08\u5bb6\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3054\u3068\u306b\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u7528\u3044\u3066\u7d71\u8a08\u7684\u30a2\u30af\u30b7\u30e7\u30f3\u30d7\u30e9\u30f3\u3092\u4f1d\u3048\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u304c\u5fc5\u8981\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\">\u30d0\u30a4\u30aa\u30b9\u30bf\u30c6\u30a3\u30b7\u30e3\u30f3<\/a> 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class=\"ez-toc-section\" id=\"4_Effective_Communication_of_Results\"><\/span>4.\u7d50\u679c\u306e\u52b9\u679c\u7684\u306a\u4f1d\u9054<span 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class=\"ez-toc-section\" id=\"5_Finalization_of_Clinical_Study_Report_NDA_Preparation\"><\/span>5.\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u6700\u7d42\u4f5c\u6210\u3068NDA\u306e\u6e96\u5099<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5f93\u6765\u3001\u7d71\u8a08\u5b66\u8005\u306f\u65b0\u85ac\u7533\u8acb\uff08NDA\uff09\u306b\u95a2\u308f\u308b\u8b70\u8ad6\u304b\u3089\u9664\u5916\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u3053\u306e10\u5e74\u9593\u3067\u3001NDA\u3092\u4f5c\u6210\u3059\u308b\u969b\u306b\u7d71\u8a08\u5b66\u8005\u3092\u52a0\u3048\u308b\u3068\u3044\u3046\u524d\u5411\u304d\u306a\u5909\u5316\u304c\u898b\u3089\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u5909\u5316\u306f\u3001\u30c7\u30fc\u30bf\u306e\u30af\u30ec\u30f3\u30b8\u30f3\u30b0\u3001\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u3001\u6574\u7406\u306a\u3069\u306e\u5c02\u9580\u6027\u304c\u9ad8\u307e\u3063\u305f\u3053\u3068\u3067\u3001\u81e8\u5e8a\u7d71\u8a08\u5bb6\u304c\u81e8\u5e8a\u8a66\u9a13\u306e\u5831\u544a\u30d7\u30ed\u30bb\u30b9\u306b\u6b20\u304b\u305b\u306a\u3044\u5b58\u5728\u3068\u306a\u3063\u305f\u3053\u3068\u304c\u4e00\u56e0\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u7d71\u8a08\u5b66\u8005\u3068\u81e8\u5e8a\u30d7\u30ed\u30b0\u30e9\u30de\u30fc\u304c\u9023\u643a\u3057\u3001\u30c7\u30fc\u30bf\u306e\u5197\u9577\u6027\u3001\u975e\u66d6\u6627\u6027\u3001\u6709\u52b9\u6027\u306e\u4f4e\u6e1b\u306b\u91cd\u70b9\u3092\u7f6e\u304d\u306a\u304c\u3089\u3001\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u305f\u3081\u306e\u30c7\u30fc\u30bf\u306e\u6b63\u898f\u5316\u3001\u5206\u5e03\u3001\u8996\u899a\u5316\u3092\u884c\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u30c7\u30fc\u30bf\u3092\u793a\u3057\u305f\u4ed8\u5c5e\u306e\u81e8\u5e8a\u5831\u544a\u66f8\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u5be9\u67fb\u4f1a\u306e\u8981\u6c42\u306b\u5fdc\u3058\u3066\u6700\u7d42\u7684\u306b\u4f5c\u6210\u3055\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u7d71\u8a08\u5b66\u8005\u306f\u3001\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u305f\u610f\u601d\u6c7a\u5b9a\u306e\u6839\u62e0\u3092\u78ba\u7acb\u3057\u3001\u30c7\u30fc\u30bf\u306e\u8aac\u5f97\u529b\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/p>\n<p><strong>\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u81e8\u5e8a\u73fe\u5834\u306e\u96f0\u56f2\u6c17\u304c\u6f02\u3046\u73fe\u5728\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5bb6\u306f\u3001\u533b\u85ac\u54c1\u3084\u30c7\u30d0\u30a4\u30b9\u306e\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u5927\u91cf\u306e\u30d3\u30c3\u30b0\u30c7\u30fc\u30bf\u3092\u89e3\u8aad\u3057\u3001\u6709\u7528\u306a\u30d3\u30b8\u30e5\u30a2\u30eb\u306b\u5909\u63db\u3057\u3066\u898f\u5236\u6a5f\u95a2\u306b\u63d0\u793a\u3059\u308b\u3068\u3044\u3046\u5927\u304d\u306a\u4efb\u52d9\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n<p>\u6700\u8fd1\u3067\u306f\u3001\u81e8\u5e8a\u7d71\u8a08\u5b66\u8005\u304c\u3001\u78ba\u7387\u5206\u5e03\u30e2\u30c7\u30eb\u3092\u542b\u3080\u7d71\u8a08\u624b\u6cd5\u3092\u533b\u7642\u30c7\u30fc\u30bf\u306b\u5b9f\u7528\u7684\u306b\u9069\u7528\u3059\u308b\u7cbe\u5ea6\u3092\u793a\u3057\u59cb\u3081\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u75ab\u5b66\u7814\u7a76\u8005\u306f\u3001\u75c5\u6c17\u306e\u9032\u884c\u3001\u75c5\u6c17\u306e\u6709\u75c5\u7387\u3084\u7f79\u60a3\u7387\u3092\u4ee5\u524d\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u6df1\u304f\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<p>\u7d71\u8a08\u3068\u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\u304c\u533b\u7642\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u652f\u914d\u3057\u7d9a\u3051\u308b\u4e2d\u3067\u3001\u3053\u306e\u4e0a\u6607\u50be\u5411\u306f\u591a\u304f\u306e\u4eba\u306b\u3068\u3063\u3066\u660e\u308b\u3044\u5146\u3057\u3067\u3042\u308b\u3053\u3068\u306f\u9593\u9055\u3044\u3042\u308a\u307e\u305b\u3093\u3002\u79d1\u5b66\u8005\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u4e16\u754c\u306e\u898f\u5236\u6a5f\u95a2\u304c\u65b0\u85ac\u7533\u8acb\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3084\u63d0\u51fa\u57fa\u6e96\u3092\u6539\u8a02\u3057\u7d9a\u3051\u3066\u3044\u308b\u4e2d\u3067\u3001\u5b9a\u671f\u7684\u306b\u767a\u8868\u3055\u308c\u308b\u5909\u66f4\u70b9\u3084\u958b\u767a\u72b6\u6cc1\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u307e\u3059\u307e\u3059\u591a\u304f\u306e\u4f01\u696d\u304c\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u4e0d\u5099\u306b\u3088\u308b\u62d2\u7d76\u3084CRL\uff08Complete Response Letter\uff09\u306b\u76f4\u9762\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u85ac\u4e8b\u627f\u8a8d\u306e\u8fc5\u901f\u5316\u3092\u6c42\u3081\u308b\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u65b9\u306f\u3001\u305c\u3072 <a href=\"https:\/\/www.kolabtree.com\/services\/statistical-analysis\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Freelance-Statisticians-Research\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30fb\u30b9\u30bf\u30c6\u30a3\u30b7\u30e3\u30f3<\/a> \u7dfb\u5bc6\u306a\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u305f\u81e8\u5e8a\u958b\u767a\u306e\u9053\u7b4b\u3092\u8a2d\u8a08\u3057\u3066\u304f\u308c\u308b\u4eba\u304c\u3044\u307e\u3059\u3002<\/p>\n<p><strong>\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5b66\u8005\u3092\u304a\u63a2\u3057\u3067\u3059\u304b\uff1fKolabtree\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u308b\u6570\u591a\u304f\u306e\u751f\u7269\u7d71\u8a08\u5b66\u8005\u306e\u4e2d\u304b\u3089\u9078\u3076\u304b\u3001\u3042\u308b\u3044\u306f\u5358\u306b <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Freelance-Statisticians-Research#create-project\">\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u7121\u6599\u3067\u6295\u7a3f\u3067\u304d\u307e\u3059\u3002<\/a>.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>There is an unprecedented demand for freelance statisticians\u00a0in research, especially in clinical research, However, as the progress towards real-world data &amp; real-world evidence continues, there is more and more emphasis on how a statistician\u2019s expertise cannot be limited to just the knowledge of statistical methods. Research in public health and epidemiology has been growing rapidly, and scientists are choosing to hire freelance statisticians to design clinical trials and get better results of their research. Successful design and performance of clinical trials require statisticians to get more\u00a0exposed to laboratory experiments. While working on clinical research, freelance statisticians are expected to internalize the objectives of the clinical trial, store different forms of<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-freelance-statisticians-can-improve-research\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":32,"featured_media":5847,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[305,398,443,435],"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 Freelance Statisticians Can Improve Research - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"The role of freelance statisticians in research is paramount: they help design clinical trials, conduct surveys, verify research results and minimize errors in research studies.\" \/>\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-freelance-statisticians-can-improve-research\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How Freelance Statisticians Can Improve Research\" \/>\n<meta property=\"og:description\" content=\"The role of freelance statisticians in research is paramount: they help design clinical trials, conduct surveys, verify research results and minimize errors in research studies.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-freelance-statisticians-can-improve-research\/\" \/>\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=\"2019-07-30T10:22:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-01-06T14:01:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/07\/freelance-statisticians-research.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1267\" \/>\n\t<meta property=\"og:image:height\" content=\"950\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mahasweta Pal\" \/>\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=\"Mahasweta Pal\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"7\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How Freelance Statisticians Can Improve Research - 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