{"id":7645,"date":"2019-09-06T13:00:07","date_gmt":"2019-09-06T04:00:07","guid":{"rendered":"https:\/\/www.enago.com\/academy\/jp\/?p=7645"},"modified":"2023-04-05T13:11:27","modified_gmt":"2023-04-05T04:11:27","slug":"us-univ_register-clinical-trial-results","status":"publish","type":"post","link":"https:\/\/www.enago.com\/academy\/jp\/us-univ_register-clinical-trial-results\/","title":{"rendered":"\u7c73\u56fd\u5927\u5b66\u304c\u81e8\u5e8a\u8a66\u9a13\u306e\u516c\u8868\u3067\u6cd5\u4ee4\u9055\u53cd"},"content":{"rendered":"<p>\u7814\u7a76\u4e0d\u6b63\u306f\u7814\u7a76\u8005\u3067\u306a\u304f\u3068\u3082\u898b\u9003\u305b\u306a\u3044\u554f\u984c\u3067\u3059\u3002\u3068\u304f\u306b\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308b\u4e0d\u6b63\u306f\u3001\u60a3\u8005\u306e\u5065\u5eb7\u306b\u76f4\u63a5\u7684\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u306e\u3067\u6ce8\u76ee\u3055\u308c\u307e\u3059\u304c\u3001\u533b\u85ac\u54c1\u3084\u6cbb\u7642\u6cd5\u306e\u8a55\u4fa1\u306b\u3082\u5927\u304d\u304f\u5f71\u97ff\u3057\u307e\u3059\u3002<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u306e\u516c\u8868\u306b\u3064\u3044\u3066\u306f\u3001\u591a\u304f\u306e\u56fd\u3067\u8b70\u8ad6\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u7c73\u56fd\u3067\u306f\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u306f1\u5e74\u4ee5\u5185\u306b\u516c\u958b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u6cd5\u3067\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u540c\u69d8\u306b\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u3082\u30e8\u30fc\u30ed\u30c3\u30d1\u3067\u884c\u308f\u308c\u308b\u533b\u85ac\u54c1\u958b\u767a\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u7d42\u4e86\u5f8c12\u30f6\u6708\u4ee5\u5185\u306b<a href=\"https:\/\/www.clinicaltrialsregister.eu\/\" target=\"_blank\" rel=\"noopener noreferrer\">EU Clinical Trials Register\uff08EUCTR\uff09<\/a>\u306b\u7d50\u679c\u3092\u5831\u544a\u3059\u308b\u3088\u3046\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u7814\u7a76\u8005\u306f\u502b\u7406\u7684\u8cac\u4efb\u3092\u6709\u3059\u308b\u306b\u3082\u95a2\u3089\u305a\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u304c\u5426\u5b9a\u7684\u306a\u5834\u5408\u306a\u3069\u306b\u7d50\u679c\u3092\u516c\u8868\u3057\u306a\u3044\u50be\u5411\u304c\u3042\u308b\u3053\u3068\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3067\u3059\u304c\u3001\u5b9f\u969b\u306b\u306f\u591a\u304f\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u304c\u5831\u544a\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u6307\u6458\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305d\u3057\u3066\u3001\u4eca\u5e743\u6708\u306b\u767a\u8868\u3055\u308c\u305f\u5831\u544a\u66f8\u3067\u3082\u3001\u7c73\u56fd\u306e\u5927\u5b66\u304c\u652f\u63f4\u3057\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u304c\u3001\u653f\u5e9c\u306e\u5b9a\u3081\u308b\u516c\u8868\u671f\u9650\u3092\u5b88\u3063\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<div id=\"om-wxx776qo5w3etxr3cpps-holder\"><\/div>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u6b21<\/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\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><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\" 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>\u6cd5\u4ee4\u6574\u5099\u2015FDA\u306b\u3088\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u767b\u9332\u7fa9\u52d9\u4ed8\u3051\u3068HHS\u306b\u3088\u308b\u81e8\u5e8a\u8a66\u9a13\u60c5\u5831\u958b\u793a\u898f\u5247<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.enago.com\/academy\/jp\/us-univ_register-clinical-trial-results\/#%E6%B3%95%E4%BB%A4%E9%81%95%E5%8F%8D%E2%80%95%E5%85%AC%E8%A1%A8%E3%81%95%E3%82%8C%E3%81%AA%E3%81%8B%E3%81%A3%E3%81%9F%E8%A9%A6%E9%A8%93%E7%B5%90%E6%9E%9C\" >\u6cd5\u4ee4\u9055\u53cd\u2015\u516c\u8868\u3055\u308c\u306a\u304b\u3063\u305f\u8a66\u9a13\u7d50\u679c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.enago.com\/academy\/jp\/us-univ_register-clinical-trial-results\/#%E4%B8%96%E7%95%8C%E3%81%A7%E3%82%82%E9%80%B2%E3%82%80%E6%83%85%E5%A0%B1%E5%85%AC%E9%96%8B\" 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id=\"%E6%B3%95%E4%BB%A4%E6%95%B4%E5%82%99%E2%80%95FDA%E3%81%AB%E3%82%88%E3%82%8B%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A8%93%E3%81%AE%E7%99%BB%E9%8C%B2%E7%BE%A9%E5%8B%99%E4%BB%98%E3%81%91%E3%81%A8HHS%E3%81%AB%E3%82%88%E3%82%8B%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A8%93%E6%83%85%E5%A0%B1%E9%96%8B%E7%A4%BA%E8%A6%8F%E5%89%87\"><\/span>\u6cd5\u4ee4\u6574\u5099\u2015FDA\u306b\u3088\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u767b\u9332\u7fa9\u52d9\u4ed8\u3051\u3068HHS\u306b\u3088\u308b\u81e8\u5e8a\u8a66\u9a13\u60c5\u5831\u958b\u793a\u898f\u5247<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u767b\u9332\u3001\u6709\u5bb3\u4e8b\u8c61\u3084\u526f\u4f5c\u7528\u60c5\u5831\u3001\u8a66\u9a13\u7d50\u679c\u306e\u767b\u9332\u3092\u4fc3\u3059\u305f\u3081\u306e\u6cd5\u6539\u6b63\uff08<a href=\"https:\/\/clinicaltrials.gov\/ct2\/manage-recs\/fdaaa\" target=\"_blank\" rel=\"noopener noreferrer\">FDAAA Section 801<\/a>\uff09\u3092\u884c\u3044\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u767b\u9332\u3092\u7fa9\u52d9\u4ed8\u3051\u307e\u3057\u305f\u3002\u3053\u306e\u6cd5\u4ee4\u306b\u57fa\u3065\u304d\u3001\u3055\u3089\u306b\u8a73\u7d30\u306a\u898f\u5247\u3092\u7c73\u56fd\u4fdd\u5065\u798f\u7949\u7701\uff08HHS\uff09\u304c\u4f5c\u6210\u3057\u30012016\u5e749\u670816\u65e5\u306b\u306f\u81e8\u5e8a\u8a66\u9a13\u7d50\u679c\u306e\u516c\u8868\u7bc4\u56f2\u3092\u62e1\u5927\u3059\u308b\u898f\u5247\uff08<a href=\"https:\/\/prsinfo.clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">42CFR Part11<\/a>\uff09\u3092\u767a\u884c\u3002\u3053\u306e\u65b0\u898f\u5247\u306f\u3001\u7c73\u56fd\u56fd\u7acb\u885b\u751f\u7814\u7a76\u6240\uff08NIH\uff09\u306e\u904b\u55b6\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u60c5\u5831\u306e\u30ec\u30b8\u30b9\u30c8\u30ea<a href=\"https:\/\/clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">ClinicalTrials.gov<\/a>\u306b\u516c\u958b\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u60c5\u5831\u306e\u516c\u958b\u7bc4\u56f2\u3092\u62e1\u5927\u3059\u308b\u3082\u306e\u3067\u3001\u539f\u5247\u3068\u3057\u3066\u81e8\u5e8a\u8a66\u9a13\u306e\u5b8c\u4e86\u304b\u30891\u5e74\u4ee5\u5185\u306b\u7d50\u679c\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u65b0\u898f\u5247\u306f2017\u5e741\u670818\u65e5\u304b\u3089\u65bd\u884c\u3055\u308c\u3001FDA\u3078\u306e\u4e8b\u524d\u767b\u9332\u3084\u7d50\u679c\u5831\u544a\u7fa9\u52d9\u3092\u9806\u5b88\u3057\u306a\u3044\u5834\u5408\u306b\u306f\u3001\u6700\u59271\u4e07US\u30c9\u30eb\u306e\u7f70\u91d1\u3084\u7814\u7a76\u8cc7\u91d1\u306e\u5dee\u3057\u6b62\u3081\u306a\u3069\u306e\u7f70\u5247\u304c\u8ab2\u305b\u3089\u308c\u308b\u3053\u3068\u3082\u660e\u8a18\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u4ee5\u524d\u306f\u4efb\u610f\u3067\u3042\u3063\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u60c5\u5831\u767b\u9332\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u305f\u4e0a\u3001\u533b\u85ac\u54c1\u306e\u8ca9\u58f2\u627f\u8a8d\u304c\u5f97\u3089\u308c\u306a\u304b\u3063\u305f\u3082\u306e\u3082\u542b\u3081\u3001\u3042\u3089\u3086\u308b\u7d50\u679c\u3092\u767b\u9332\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u308b\u3053\u3068\u3068\u306a\u308a\u307e\u3057\u305f\u3002\u516c\u8868\u7fa9\u52d9\u3092\u514d\u308c\u308b\u306e\u306f\u3001\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u30d5\u30a7\u30fc\u30ba\uff11\u306e\u81e8\u5e8a\u8a66\u9a13\uff08\u5c11\u4eba\u6570\u306e\u5065\u5e38\u8005\u30dc\u30e9\u30f3\u30c6\u30a3\u30a2\u3092\u5bfe\u8c61\u3068\u3059\u308b\u521d\u671f\u306e\u8a66\u9a13\uff09\u306a\u3069\u3067\u3001\u3054\u304f\u4e00\u90e8\u306b\u9650\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E6%B3%95%E4%BB%A4%E9%81%95%E5%8F%8D%E2%80%95%E5%85%AC%E8%A1%A8%E3%81%95%E3%82%8C%E3%81%AA%E3%81%8B%E3%81%A3%E3%81%9F%E8%A9%A6%E9%A8%93%E7%B5%90%E6%9E%9C\"><\/span>\u6cd5\u4ee4\u9055\u53cd\u2015\u516c\u8868\u3055\u308c\u306a\u304b\u3063\u305f\u8a66\u9a13\u7d50\u679c<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>2019\u5e743\u6708\u3001\u300c\u7c73\u56fd\u5927\u5b66\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u900f\u660e\u6027\uff08\u539f\u984c\uff1aClinical trial transparency at US universities\uff09\u300d\u3068\u984c\u3057\u3066\u81e8\u5e8a\u8a66\u9a13\u7d50\u679c\u306e\u72b6\u6cc1\u306b\u95a2\u3059\u308b\u554f\u984c\u3092<a href=\"https:\/\/www.altreroute.com\/clinicaltrials\/assets\/download\/UniversityTransparencyReport2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">\u5831\u544a<\/a>\u3057\u305f\u306e\u306f\u3001\u7814\u7a76\u306e\u900f\u660e\u6027\u306e\u4fc3\u9032\u3092\u56f3\u3063\u3066\u3044\u308b<a href=\"https:\/\/www.transparimed.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">TranspariMED<\/a>\u3068<a href=\"https:\/\/www.uaem.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Universities Allied for Essential Medicines(UAEM)<\/a>\u306e2\u7d44\u7e54\u3067\u3059\u3002\u3053\u306e\u7814\u7a76\u7d50\u679c\u306f\u3001Nature\u8a8c\u306b\u3082\u7d39\u4ecb\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>\u8abf\u67fb\u5bfe\u8c61\u306b\u306a\u3063\u305f\u306e\u306f\u3001\u7c73\u56fd\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5927\u534a\u3092\u884c\u3063\u3066\u3044\u308b40\u5927\u5b66\u304c\u30012017\u5e741\u6708\u4ee5\u964d\u306b\u5b9f\u65bd\u3057\u305f\u81e8\u5e8a\u8a66\u9a13450\u4ef6\u3067\u3059\u3002\u3053\u306e\u3046\u3061\u300125\u6821\u304c\u8a66\u9a13\u7d42\u4e86\u304b\u308912\u30f6\u6708\u4ee5\u5185\u306bClinicalTrial.gov\u306b\u7d50\u679c\u3092\u63b2\u8f09\u3059\u308b\u7fa9\u52d9\u3092\u6020\u3063\u3066\u3044\u305f\u3053\u3068\u3001140\u4ef6\uff0831\uff05\uff09\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u304c\u672a\u63b2\u8f09\u3067\u3042\u3063\u305f\u3053\u3068\u304c\u5224\u660e\u3057\u307e\u3057\u305f\u3002\u5927\u5b66\u306b\u3088\u308a\u5dee\u304c\u898b\u3089\u308c\u307e\u3057\u305f\u304c\u3001\u6cd5\u4ee4\u3092\u9806\u5b88\u3057\u3066\u671f\u9650\u5185\u306b\u5831\u544a\u3057\u3066\u3044\u305f\u306e\u306f15\u5927\u5b66\u306e\u307f\u3002\u6cd5\u4ee4\u9055\u53cd\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u3046\u3061\u7d045\u5272\u3092\u5360\u3081\u308b\u306e\u306f\u30015\u3064\u306e\u5927\u5b66\u306b\u3088\u308b\u3082\u306e\u3067\u3059\u3002\u672a\u5831\u544a\u4ef6\u6570\u304c\u6700\u591a\u3060\u3063\u305f\u306e\u306f\u30ab\u30ea\u30d5\u30a9\u30eb\u30cb\u30a2\u5927\u5b66\u30b5\u30f3\u30d5\u30e9\u30f3\u30b7\u30b9\u30b3\u6821\u306e17\u4ef6\uff08\u540c\u5927\u5b66\u304c\u5b9f\u65bd\u3057\u305f\u81e8\u5e8a\u8a66\u9a13\u5168\u4f53\u306e37\uff05\u304c\u672a\u5831\u544a\u3068\u306e\u7d50\u679c\uff09\u3001\u671f\u9650\u5185\u306b\u5831\u544a\u3057\u305f\u5272\u5408\u304c\u6700\u3082\u4f4e\u304b\u3063\u305f\uff082019\u5e742\u670828\u65e5\u6642\u70b9\uff09\u306e\u306f\u30b3\u30ed\u30f3\u30d3\u30a2\u5927\u5b66\u306e17\uff05\u3067\u3057\u305f\u3002\u5927\u5b66\u5074\u306f\u81ea\u3089\u306e\u7acb\u5834\u3092\u64c1\u8b77\u3059\u308b\u305f\u3081\u306e\u58f0\u660e\u3092\u767a\u8868\u3057\u3001\u30ab\u30ea\u30d5\u30a9\u30eb\u30cb\u30a2\u5927\u5b66\u30b5\u30f3\u30d5\u30e9\u30f3\u30b7\u30b9\u30b3\u6821\u306f\u300110\u4ef6\u306f\u81e8\u5e8a\u8a66\u9a13\u306e\u5b8c\u4e86\u304c\u9045\u308c\u305f\u305f\u3081\u3067\u3042\u308a\u3001\u6b8b\u308a\u306f\u30c7\u30fc\u30bf\u89e3\u6790\u306e\u9045\u308c\u3084\u8a66\u9a13\u5b8c\u4e86\u671f\u65e5\u304c\u5909\u66f4\u3055\u308c\u305f\u3053\u3068\u306b\u3088\u308b\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u30b3\u30ed\u30f3\u30d3\u30a2\u5927\u5b66\u3082\u300115\u4ef6\u306e\u8a66\u9a13\u304c\u9045\u5ef6\u3057\u3001\u3046\u3061\u5b8c\u4e86\u3057\u305f\u306e\u306f8\u4ef6\u3060\u3051\u3060\u3063\u305f\u3068\u91c8\u660e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%96%E7%95%8C%E3%81%A7%E3%82%82%E9%80%B2%E3%82%80%E6%83%85%E5%A0%B1%E5%85%AC%E9%96%8B\"><\/span>\u4e16\u754c\u3067\u3082\u9032\u3080\u60c5\u5831\u516c\u958b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306e\u4e8b\u524d\u767b\u9332\u3084\u60c5\u5831\u306e\u516c\u958b\u306b\u3064\u3044\u3066\u306f\u4e16\u754c\u5404\u56fd\u3067\u5236\u5ea6\u306e\u5c0e\u5165\u304c\u9032\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u30022005\u5e74\u306b\u306f\u4e16\u754c\u4fdd\u5065\u6a5f\u69cb\uff08WHO\uff09\u306f\u56fd\u969b\u81e8\u5e8a\u8a66\u9a13\u767b\u9332\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0International Clinical Trial Registry Platform\uff08ICTRP\uff09\u3092\u8a2d\u7f6e\u30fb\u516c\u958b\u3057\u307e\u3057\u305f\u30022015\u5e744\u6708\u306b\u306fWHO Statement on Public Disclosure of Clinical Trial Results\u3092\u767a\u8868\u3057\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u516c\u958b\u306e\u65b9\u6cd5\u3001\u671f\u9650\u306a\u3069\u306b\u95a2\u3059\u308b\u5177\u4f53\u7684\u306a\u52e7\u544a\u3092\u51fa\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u6b27\u7c73\u306e\u767b\u9332\u6a5f\u95a2\u306fWHO\u306e\u898f\u5b9a\u3088\u308a\u3082\u591a\u304f\u306e\u9805\u76ee\u3092\u5fc5\u9808\u3068\u3059\u308b\u306a\u3069\u3001\u81e8\u5e8a\u8a66\u9a13\u7d50\u679c\u306e\u516c\u958b\u3092\u63a8\u9032\u3059\u308b\u52d5\u304d\u304c\u9ad8\u307e\u3063\u3066\u304d\u3066\u3044\u307e\u3059\u3002\u767b\u9332\u60c5\u5831\u306e\u516c\u958b\u3001\u60c5\u5831\u691c\u7d22\u30b7\u30b9\u30c6\u30e0\u306e\u6574\u5099\u304c\u9032\u3080\u306b\u3064\u308c\u3001\u516c\u958b\u3055\u308c\u308b\u60c5\u5831\u91cf\u30fb\u7bc4\u56f2\u304c\u62e1\u5927\u3057\u3001\u7d50\u679c\u3068\u3057\u3066\u81e8\u5e8a\u8a66\u9a13\u306e\u900f\u660e\u6027\u306e\u78ba\u4fdd\u304c\u56f3\u3089\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u304d\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%A0%94%E7%A9%B6%E3%81%B8%E3%81%AE%E5%BD%B1%E9%9F%BF\"><\/span>\u7814\u7a76\u3078\u306e\u5f71\u97ff<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u671f\u9650\u5185\u306b\u81e8\u5e8a\u8a66\u9a13\u7d50\u679c\u3092\u516c\u958b\u3059\u308b\u3053\u3068\u306f\u3001\u7814\u7a76\u306b\u3068\u3063\u3066\u3082\u30e1\u30ea\u30c3\u30c8\u304c\u3042\u308a\u307e\u3059\u30021\u5e74\u3092\u671f\u9650\u3068\u3057\u3066\u3044\u308b\u306e\u306f\u3001\u8a66\u9a13\u7d50\u679c\u3092\u8fc5\u901f\u306b\u5171\u6709\u3059\u308b\u305f\u3081\u3067\u3059\u3002\u5b66\u8853\u30b8\u30e3\u30fc\u30ca\u30eb\u306b\u8ad6\u6587\u304c\u63b2\u8f09\u3055\u308c\u308b\u306e\u3092\u5f85\u305f\u305a\u306b\u7d50\u679c\u3092\u516c\u958b\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u5b66\u7814\u7a76\u306e\u9032\u6b69\u3092\u65e9\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3067\u3057\u3087\u3046\u3002\u671f\u9650\u304c\u77ed\u3044\u3053\u3068\u306f\u3001\u7814\u7a76\u304c\u300c\u7121\u99c4\u306b\u306a\u308b\u300d\u5371\u967a\u6027\u3092\u6291\u3048\u308b\u3053\u3068\u306b\u3082\u3064\u306a\u304c\u308a\u307e\u3059\u3002\u516c\u958b\u3059\u308b\u3053\u3068\u3067\u81e8\u5e8a\u8a66\u9a13\u306e\u76ee\u7684\u3092\u660e\u78ba\u306b\u3057\u3001\u7d50\u679c\u3068\u6bd4\u8f03\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u7814\u7a76\u4e0d\u6b63\u306e\u6291\u5236\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002\u307e\u305f\u3001\u8a66\u9a13\u7d50\u679c\u306e\u300c\u5dee\u3057\u66ff\u3048\u300d\u3084\u96a0\u853d\u306e\u6291\u6b62\u306b\u3082\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u3088\u3046\u306b\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u3092\u516c\u8868\u3059\u308b\u3053\u3068\u306f\u6709\u76ca\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u8a66\u9a13\u7d50\u679c\u304c\u9069\u5207\u306b\u516c\u8868\u3055\u308c\u306a\u3044\u554f\u984c\u306f\u7c73\u56fd\u4ee5\u5916\u3067\u3082\u6307\u6458\u3055\u308c\u3066\u3044\u307e\u3059\u3002EU Clinical Trials Register\uff08EUCTR\uff09 \u304c<a href=\"https:\/\/www.nature.com\/articles\/d41586-018-06676-8\" target=\"_blank\" rel=\"noopener noreferrer\">2018\u5e749\u6708\u306b\u767a\u8868\u3057\u305f\u8abf\u67fb<\/a>\u3067\u306f\u3001EU\u3067\u5b9f\u65bd\u3055\u308c\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u3046\u3061\u3001\u7d0450%\u304c12\u30f6\u6708\u4ee5\u5185\u306e\u81e8\u5e8a\u8a66\u9a13\u7d50\u679c\u306e\u516c\u8868\u3092\u5b9a\u3081\u3066\u3044\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u9806\u5b88\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u5927\u5b66\u306b\u304a\u3044\u3066\u306f\u30011\u5e74\u4ee5\u5185\u306b\u8a66\u9a13\u7d50\u679c\u3092\u516c\u8868\u3057\u306a\u304b\u3063\u305f\u30b1\u30fc\u30b9\u304c89\uff05\u306b\u3082\u9054\u3057\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E6%B1%82%E3%82%81%E3%82%89%E3%82%8C%E3%82%8B%E3%81%95%E3%82%89%E3%81%AA%E3%82%8B%E5%AF%BE%E7%AD%96\"><\/span>\u6c42\u3081\u3089\u308c\u308b\u3055\u3089\u306a\u308b\u5bfe\u7b56<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u78ba\u304b\u306b\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u767a\u4fe1\u3059\u308b<a href=\"https:\/\/www.statnews.com\" target=\"_blank\" rel=\"noopener noreferrer\">STAT<\/a>\u304c2015\u5e74\u306b\u767a\u8868\u3057\u305f<a href=\"https:\/\/www.statnews.com\/2015\/12\/13\/clinical-trials-investigation\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u8abf\u67fb<\/a>\u306b\u3088\u308c\u3070\u30012008\u5e74\u304b\u30892015\u5e74\u306b\u5b9f\u65bd\u3055\u308c\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u3046\u3061\u5b8c\u4e86\u5f8c1\u5e74\u4ee5\u5185\u306b\u7d50\u679c\u3092\u767a\u8868\u3057\u306a\u304b\u3063\u305f\u7c73\u56fd\u306e\u5b66\u8853\u6a5f\u95a2\u306f90\uff05\u3067\u3057\u305f\u3002\u3053\u308c\u306b\u6bd4\u8f03\u3059\u308c\u3070\u30012017\u5e74\u306e\u8ffd\u8de1\u8abf\u67fb\u3067\u904e\u53bb\u306e\u81e8\u5e8a\u8a66\u9a13\u306e512\u4ef6\u306e\u7d50\u679c\u304c\u516c\u8868\u3055\u308c\u3066\u3044\u305f\u3053\u3068\u306f\u6539\u5584\u3067\u3059\u3002\u305d\u308c\u3067\u3082\u3001777\u4ef6\u306f\u4f9d\u7136\u3068\u3057\u3066\u516c\u8868\u3055\u308c\u306a\u3044\u307e\u307e\u3067\u3042\u308b\u3053\u3068\u3092\u8e0f\u307e\u3048\u308c\u3070\u3001\u66f4\u306a\u308b\u5bfe\u7b56\u306e\u5f37\u5316\u304c\u5fc5\u8981\u3068\u8a00\u3048\u308b\u3067\u3057\u3087\u3046\u3002\u65b0\u3057\u3044\u6cd5\u4ee4\u30fb\u898f\u5247\u304c\u5168\u9762\u7684\u306b\u65bd\u884c\u3055\u308c\u305f2017\u5e741\u6708\u4ee5\u964d\u3001\u7814\u7a76\u8005\u306e\u610f\u8b58\u306b\u5909\u5316\u3082\u898b\u3089\u308c\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u767a\u8868\u304c\u6539\u5584\u50be\u5411\u306b\u3042\u308b\u3082\u306e\u306e\u3001\u767b\u9332\u3055\u308c\u308b\u3079\u304d\u30c7\u30fc\u30bf\u304c\u4e0d\u5b8c\u5168\u3060\u3068\u3001\u8a66\u9a13\u5bfe\u8c61\u3068\u3055\u308c\u305f\u533b\u85ac\u54c1\u3084\u533b\u7642\u6a5f\u5668\u306a\u3069\u306e\u6709\u52b9\u6027\u3092\u7684\u78ba\u306b\u5224\u65ad\u3059\u308b\u3053\u3068\u304c\u96e3\u3057\u304f\u306a\u308a\u3001\u696d\u754c\u5168\u4f53\u306b\u3082\u4e0d\u5229\u76ca\u3092\u3082\u305f\u3089\u3059\u3068\u306e\u6307\u6458\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u5927\u5b66\u3092\u542b\u3080\u7814\u7a76\u6a5f\u95a2\u306e\u591a\u304f\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u4e8b\u524d\u767b\u9332\u3057\u3001\u7d50\u679c\u3092\u516c\u8868\u3059\u308b\u53d6\u308a\u7d44\u307f\u3092\u9032\u3081\u3066\u304a\u308a\u3001\u6cd5\u7684\u6839\u62e0\u3082\u6574\u5099\u3055\u308c\u3066\u304d\u3066\u3044\u307e\u3059\u304c\u3001\u307e\u3060\u5341\u5206\u3067\u7121\u3044\u3053\u3068\u306f\u660e\u3089\u304b\u3067\u3059\u3002\u3055\u3089\u306b\u53b3\u683c\u306a\u6cd5\u4ee4\u3092\u5236\u5b9a\u3057\u3001\u5927\u5b66\u306b\u6cd5\u4ee4\u9806\u5b88\u3092\u3055\u305b\u3066\u3044\u304f\u3053\u3068\u304c\u5fc5\u8981\u3067\u306f\u306a\u3044\u3067\u3057\u3087\u3046\u304b\u3002<\/p>\n<hr 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