{"id":5278,"date":"2022-04-05T13:37:51","date_gmt":"2022-04-05T04:37:51","guid":{"rendered":"https:\/\/clarivate.com\/ja\/?p=5278"},"modified":"2022-04-05T13:37:51","modified_gmt":"2022-04-05T04:37:51","slug":"clinical-trials-and-pregnancy-regulators-weigh-in-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/clinical-trials-and-pregnancy-regulators-weigh-in-2\/","title":{"rendered":"\u81e8\u5e8a\u8a66\u9a13\u3068\u598a\u5a20\uff1a\u898f\u5236\u5f53\u5c40\u306e\u898b\u89e3"},"content":{"rendered":"<p><a href=\"https:\/\/clarivate.com\/blog\/clinical-trials-and-pregnancy-regulators-weigh-in\/\">\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8<\/a><\/p>\n<p><span style=\"font-size: small\">\u672c\u8a18\u4e8b\u306f\u82f1\u6587\u30d6\u30ed\u30b0\u3092\u65e5\u672c\u8a9e\u306b\u7ffb\u8a33\u518d\u7de8\u96c6\uff08\u4e00\u90e8\u8ffd\u8a18\u3092\u542b\u3080\uff09\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u8a18\u4e8b\u306e\u6b63\u5f0f\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3042\u308a\u3001\u305d\u306e\u5185\u5bb9\u30fb\u89e3\u91c8\u306b\u3064\u3044\u3066\u306f\u82f1\u8a9e\u304c\u512a\u5148\u3057\u307e\u3059\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u533b\u85ac\u54c1\u306e\u958b\u767a\u8005\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3068\u598a\u5a20\u306b\u95a2\u3057\u3066\u3057\u3070\u3057\u3070\u30b8\u30ec\u30f3\u30de\u306b\u76f4\u9762\u3057\u307e\u3059\u3002<\/strong><\/p>\n<p><strong>\u81e8\u5e8a\u8a66\u9a13\u306b\u53c2\u52a0\u3057\u305f\u304f\u306a\u3044\u3001\u3042\u308b\u3044\u306f\u53c2\u52a0\u3067\u304d\u306a\u3044\u53ef\u80fd\u6027\u306e\u3042\u308b\u96c6\u56e3\u3067\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u306f\u3001\u3069\u306e\u7a0b\u5ea6\u5b9f\u73fe\u53ef\u80fd\u306a\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u6700\u8fd1\u306e\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306e\u4f1a\u8b70\u306e\u7d50\u679c\u3068\u305d\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6848\u3092\u898b\u3066\u3001\u3088\u308a\u8a73\u7d30\u306a\u60c5\u5831\u3092\u5f97\u307e\u3057\u3087\u3046\u3002<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>2021\u5e7411\u6708\u306e\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306e\u4f1a\u8b70\u3067\u3082\u3001\u5c02\u9580\u5bb6\u305f\u3061\u306f\u3053\u306e\u81e8\u5e8a\u8a66\u9a13\u3068\u598a\u5a20\u3068\u3044\u3046\u30c6\u30fc\u30de\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002<\/p>\n<p>\u6297\u83cc\u85ac\u8aee\u554f\u59d4\u54e1\u4f1a\u306f\u3001\u91cd\u5ea6\u306eCOVID-19\u304a\u3088\u3073\/\u307e\u305f\u306f\u5165\u9662\u306b\u9032\u884c\u3059\u308b\u30ea\u30b9\u30af\u306e\u3042\u308b\u6210\u4eba\u306b\u304a\u3051\u308b\u8efd\u5ea6\u304b\u3089\u4e2d\u7a0b\u5ea6\u306e<a href=\"https:\/\/clarivate.com\/blog\/five-ways-covid-19-has-changed-healthcare-provision-and-what-it-means-for-pharmas\/\">COVID-19<\/a>\u306e\u6cbb\u7642\u306b\u5bfe\u3059\u308b\u30e1\u30eb\u30af\u793e\u306e\u30e2\u30eb\u30cc\u30d4\u30e9\u30d3\u30eb\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092<a href=\"https:\/\/www.cortellis.com\/intelligence\/suite\/report\/regulatory\/338753\" target=\"_blank\" rel=\"noopener\">\u50c5\u5dee\u3067\u652f\u6301<\/a>\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u4f1a\u8b70\u306b\u5148\u7acb\u3061\u3001FDA\u306f\u30e2\u30eb\u30cc\u30d4\u30e9\u30d3\u30eb\u306e\u5909\u7570\u539f\u6027\u3001\u80da\u30fb\u80ce\u5150\u6bd2\u6027\u3001\u9aa8\u30fb\u8edf\u9aa8\u6210\u9577\u969c\u5bb3\u306a\u3069\u306e\u975e\u81e8\u5e8a\u6240\u898b\uff08\u52d5\u7269\u8a66\u9a13\uff09\u3092\u5f37\u8abf\u3057\u307e\u3057\u305f\u3002\u30d1\u30cd\u30ea\u30b9\u30c8\u306f\u3001\u598a\u5a20\u4e2d\u306e\u672c\u5264\u306e\u4f7f\u7528\u306e\u53ef\u80fd\u6027\u306b\u3064\u3044\u3066\u8b70\u8ad6\u3059\u308b\u3088\u3046\u6c42\u3081\u3089\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>11\u6708\u306e\u4f1a\u8b70\u3067FDA\u306e\u5be9\u67fb\u5b98\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u85ac\u5264\u306e\u30ea\u30b9\u30af\u8efd\u6e1b\u7b56\u306e1\u3064\u306f\u3001\u598a\u5a20\u4e2d\u306e\u4f7f\u7528\u3092\u8a31\u53ef\u3057\u306a\u3044\u3053\u3068\u3067\u3042\u308b\u3068\u8ff0\u3079\u307e\u3057\u305f\u3002\u3053\u306e\u65b9\u6cd5\u306f\u3001\u598a\u5a20\u4e2d\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u304c\u30ea\u30b9\u30af\u3092\u4e0a\u56de\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u81e8\u5e8a\u30b7\u30ca\u30ea\u30aa\u304c\u306a\u3044\u5834\u5408\u306b\u9069\u5207\u3067\u3042\u308b\u3068\u3001FDA\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u3088\u308a\u9650\u5b9a\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u3057\u3066\u306f\u3001\u598a\u5a20\u4e2d\u306e\u4f7f\u7528\u3092\u63a8\u5968\u3057\u306a\u3044\u3053\u3068\u3067\u3059\u304c\u3001\u598a\u5a20\u306f\u8a8d\u53ef\u3055\u308c\u305f\u4f7f\u7528\u306e\u5236\u9650\u3068\u306f\u307f\u306a\u3055\u308c\u307e\u305b\u3093\u3002\u598a\u5a20\u4e2d\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u304c\u30ea\u30b9\u30af\u3092\u4e0a\u56de\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u7279\u5b9a\u306e\u81e8\u5e8a\u30b7\u30ca\u30ea\u30aa\u306b\u304a\u3044\u3066\u306f\u3001\u51e6\u65b9\u8005\u306e\u88c1\u91cf\u3067\u598a\u5a20\u4e2d\u306b\u672c\u5264\u3092\u51e6\u65b9\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u598a\u5a20\u4e2d\u306e\u533b\u85ac\u54c1\u4f7f\u7528\uff1a\u30ea\u30b9\u30af\u3068\u306e\u30d0\u30e9\u30f3\u30b9<\/strong><\/h3>\n<p><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">FDA<\/a>\u306f\u6700\u8fd1\u306e\u6d3b\u52d5\u306e\u4e2d\u3067\u3001\u8868\u793a\u3084\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u306e\u5224\u65ad\u306b\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306e\u30c7\u30fc\u30bf\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3057\u3001\u598a\u5a20\u4e2d\u304a\u3088\u3073\u6388\u4e73\u4e2d\u306e\u4eba\u3005\u306e\u7814\u7a76\u3092\u4fc3\u9032\u3059\u308b\u3053\u3068\u306b\u30b3\u30df\u30c3\u30c8\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u307e\u3057\u305f\u3002FDA\u306f\u3001\u3053\u306e\u305f\u3081\u306b<a href=\"https:\/\/healthpolicy.duke.edu\/\" target=\"_blank\" rel=\"noopener\">Duke University Robert J. Margolis Center for Health Policy<\/a>\u3068\u5354\u529b\u3057\u3001<a href=\"https:\/\/clarivate.com\/blog\/digital-innovation-in-drug-development-here-to-stay-perspectives-from-pharma-tech-and-regulatory-experts\/\">\u533b\u85ac\u54c1\u958b\u767a<\/a>\u306e\u305f\u3081\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u598a\u5a20\u4e2d\u306e\u4eba\u3092\u767b\u9332\u3059\u308b\u3053\u3068\u306b\u95a2\u9023\u3059\u308b\u79d1\u5b66\u7684\u30fb\u502b\u7406\u7684\u554f\u984c\u306b\u3064\u3044\u30662021\u5e742\u6708\u306b\u516c\u958b\u4f1a\u8b70\u3092\u958b\u50ac\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u7c73\u56fd\u4fdd\u5065\u793e\u4f1a\u798f\u7949\u7701\u306f\u3001\u300c<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/common-rule\/index.html\" target=\"_blank\" rel=\"noopener\">Federal Policy for Protection of Human Research Subjects<\/a>\u300d\uff08Common Rule\u3068\u3082\u547c\u3070\u308c\u308b\uff09\u304b\u3089\u3001\u598a\u5a20\u4e2d\u306e\u4eba\u3005\u3092\u300c\u8106\u5f31\u306a\u5b58\u5728\u300d\u3068\u3059\u308b\u8a18\u8ff0\u3092\u524a\u9664\u3057\u307e\u3057\u305f\u3002FDA\u306f\u30012018\u5e7410\u6708\u306e\u300c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/impact-certain-provisions-revised-common-rule-fda-regulated-clinical-investigations\" target=\"_blank\" rel=\"noopener\">Guidance for Sponsors, Investigators, and Institutional Review Boards: Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations (Final)<\/a>\u300d\u306b\u3042\u308b\u3088\u3046\u306b\u3001Common Rule\u3068\u306e\u8abf\u548c\u3092\u56f3\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u598a\u5a20\u4e2d\u306e\u4eba\u306b\u5bfe\u3059\u308b\u30e9\u30d9\u30eb\u60c5\u5831\u306f\u3001\u901a\u5e38\u3001\u975e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001\u201cwith or without limited human safety data,\u201d\u3068\u3001FDA\u306f2018\u5e744\u6708\u306e\u300cDraft Guidance for Industry: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials\u300d\u3067\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\u60c5\u5831\u306e\u6b20\u5982\u306f\u3001\u533b\u7642\u63d0\u4f9b\u8005\u3084\u60a3\u8005\u304c\u57fa\u790e\u75be\u60a3\u306e\u6cbb\u7642\u3092\u898b\u5408\u308f\u305b\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u3001\u89aa\u3084\u80ce\u5150\u306b\u3068\u3063\u3066\u3001\u6cbb\u7642\u3092\u53d7\u3051\u305f\u5834\u5408\u3088\u308a\u3082\u300c\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3088\u308a\u5927\u304d\u306a\u5bb3\u3092\u3082\u305f\u3089\u3059\u304b\u3082\u3057\u308c\u306a\u3044\u300d\u306e\u3067\u3059\u3002\u307e\u305f\u3001\u533b\u7642\u4e0a\u5fc5\u8981\u306a\u533b\u85ac\u54c1\u3092\u4f7f\u7528\u3059\u308b\u500b\u4eba\u304c\u3001\u81ea\u5206\u81ea\u8eab\u3084\u80ce\u5150\u3078\u306e\u5229\u76ca\u3068\u30ea\u30b9\u30af\u3092\u7406\u89e3\u305b\u305a\u306b\u4f7f\u7528\u3059\u308b\u5834\u5408\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u598a\u5a20\u3068\u81e8\u5e8a\u8a66\u9a13<\/strong><\/h3>\n<p>2018\u5e744\u6708\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6848\u3067\u306f\u3001\u598a\u5a20\u4e2d\u306e\u4eba\u3092\u81e8\u5e8a\u8a66\u9a13\u306b\u542b\u3081\u308b\u3053\u3068\u3092\u6b63\u5f53\u5316\u3059\u308b\u3044\u304f\u3064\u304b\u306e\u7406\u7531\u3092\u6319\u3052\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li>\u598a\u5a20\u4e2d\u306e\u4eba\u304c\u5229\u7528\u3057\u3084\u3059\u304f\u3001\u5b89\u5168\u3067\u52b9\u679c\u7684\u306a\u6cbb\u7642\u6cd5\u306e\u9078\u629e\u80a2\u304c\u306a\u3044\u3053\u3068\u306f\u3001\u516c\u8846\u885b\u751f\u4e0a\u306e\u91cd\u5927\u306a\u554f\u984c\u3067\u3042\u308b\u3002<\/li>\n<li>\u598a\u5a20\u4e2d\u306b\u4f7f\u7528\u3055\u308c\u308b\u6cbb\u7642\u6cd5\u306e\u7528\u91cf\u30fb\u6295\u4e0e\u6cd5\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u304c\u78ba\u7acb\u3055\u308c\u3066\u3044\u306a\u3044\u3068\u3001\u598a\u5a20\u4e2d\u306e\u4eba\u3068\u305d\u306e\u80ce\u5150\u306e\u5065\u5eb7\u304c\u640d\u306a\u308f\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u598a\u5a20\u4e2d\u306e\u4eba\u3068\u305d\u306e\u80ce\u5150\u306f\u3001\u7814\u7a76\u74b0\u5883\u4ee5\u5916\u3067\u306f\u4e0d\u53ef\u80fd\u306a\u65b9\u6cd5\u3067\u3001\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u53c2\u52a0\u304b\u3089\u76f4\u63a5\u5229\u76ca\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u4e00\u7bc0\u3001\u300cFDA Regulations That Govern Research in Pregnant Women\u300d\u3067\u306f\u3001HHS\u304c\u652f\u63f4\u307e\u305f\u306f\u5b9f\u65bd\u3059\u308b\u8a66\u9a13\u3067\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3044\u304f\u3064\u304b\u306e\u6761\u4ef6\u3092\u660e\u3089\u304b\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u30012020\u5e747\u6708\u306e\u300c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/pregnancy-lactation-and-reproductive-potential-labeling-human-prescription-drug-and-biological\" target=\"_blank\" rel=\"noopener\">Draft Guidance for Industry, Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products\u2014Content and Format (Revision 1)<\/a>\u300d\u306b\u3042\u308b\u3088\u3046\u306b\u3001\u598a\u5a20\u30fb\u6388\u4e73\u671f\u306e\u8868\u793a\u898f\u5247\u3067\u306f\u3001\u30ea\u30b9\u30af\u306e\u6982\u8981\u3001\u81e8\u5e8a\u7684\u8003\u5bdf\u3001\u30d2\u30c8\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\uff08\u5165\u624b\u53ef\u80fd\u306a\u5834\u5408\uff09\u3001\u52d5\u7269\u30c7\u30fc\u30bf\u306e\u6982\u8981\u3092\u542b\u3081\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u598a\u5a20\u53ef\u80fd\u306a\u5973\u6027\u3084\u7537\u6027\u306b\u5bfe\u3057\u3066\u306f\u3001\u598a\u5a20\u691c\u67fb\u3001\u907f\u598a\u3001\u4e0d\u598a\u75c7\u306b\u95a2\u3059\u308b\u9805\u76ee\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>2\u6708\u306e\u4f1a\u8b70\u306b\u304a\u3051\u308bFDA\u306e\u8b1b\u6f14\u8005\u306f\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u8003\u616e\u306f\u3001\u8a2d\u5b9a\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3068\u8ff0\u3079\u305f\u3002\u3053\u308c\u3089\u306e\u8003\u616e\u4e8b\u9805\u306b\u306f\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u6295\u4e0e\u91cf\u3001\u598a\u5a20\u53ef\u80fd\u306a\u5e74\u9f62\u3001\u75be\u60a3\u306e\u6df1\u523b\u3055\u3001\u6cbb\u7642\u30aa\u30d7\u30b7\u30e7\u30f3\u306e\u5229\u7528\u53ef\u80fd\u6027\u306a\u3069\u3092\u793a\u3059\u30c7\u30fc\u30bf\u306e\u91cf\u304c\u542b\u307e\u308c\u308b\u3002\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u304c\u6271\u3046\u30c7\u30fc\u30bf\u304c\u8c4a\u5bcc\u306a\u305f\u3081\u3001\u5b9f\u65bd\u3057\u3084\u3059\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u53d6\u308a\u7d44\u3080\u3079\u304d\u9818\u57df\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u7279\u5b9a\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<ul>\n<li>\u898f\u5236\u8981\u4ef6\u304c\u6e80\u305f\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b<\/li>\n<li>\u201cOpportunistic\u201d\u306a\u85ac\u7269\u52d5\u614b\u8a66\u9a13\u304c\u3001\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\uff08\u4f8b\uff1a\u65e5\u5e38\u8a3a\u7642\u3067\u63a1\u53d6\u3057\u305f\u8840\u6db2\uff09<\/li>\n<li>\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u304c\u826f\u597d\u3067\u3042\u308c\u3070\u3001\u4ecb\u5165\u8a66\u9a13\u304c\u9069\u5207\u3067\u3042\u308b<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>FDA\u306f\u30012021\u5e742\u6708\u306e\u4f1a\u8b70\u304b\u3089\u306e\u610f\u898b\u3092\u30012018\u5e744\u6708\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u8349\u6848\u306e\u78ba\u5b9a\u306b\u6d3b\u7528\u3059\u308b\u610f\u5411\u3092\u8868\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u308b\u3068\u3001FDA\u306f &#8220;\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u598a\u5a66\u306e\u53c2\u52a0\u3068\u6f5c\u5728\u7684\u306a\u80ce\u5150\u30ea\u30b9\u30af\u3078\u306e\u614e\u91cd\u306a\u914d\u616e\u3092\u901a\u3058\u3066\u3001\u598a\u5a20\u4e2d\u306e\u533b\u85ac\u54c1\u304a\u3088\u3073\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3059\u308b\u305f\u3081\u306e\u60c5\u5831\u306b\u57fa\u3065\u3044\u305f\u30d0\u30e9\u30f3\u30b9\u306e\u3068\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u652f\u63f4\u3059\u308b&#8221;\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>FDA\u306e\u696d\u754c\u5411\u3051\u95a2\u9023\u51fa\u7248\u7269\u306b\u306f\u30012020\u5e7411\u6708\u306e\u6700\u7d42\u30ac\u30a4\u30c0\u30f3\u30b9\u300c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial\" target=\"_blank\" rel=\"noopener\">Enhancing the Diversity of Clinical Trial Populations \u2014 Eligibility Criteria, Enrollment Practices, and Trial Designs<\/a>\u300d\u3068\u30012019\u5e745\u6708\u306e2\u3064\u306e\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u300c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/postapproval-pregnancy-safety-studies-guidance-industry\" target=\"_blank\" rel=\"noopener\">Postapproval Pregnancy Safety Studies<\/a>\u300d\u304a\u3088\u3073\u300c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-lactation-studies-considerations-study-design\" target=\"_blank\" rel=\"noopener\">Clinical Lactation Studies: Considerations for Study Design<\/a>\u300d\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><a class=\"btn btn-primary-accessible\" href=\"https:\/\/clarivate.com\/products\/biopharma\/bioworld\/\">FDA\u3068\u696d\u754c\u306e\u6700\u65b0\u60c5\u5831\u3092\u304a\u5c4a\u3051\u3059\u308b\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u30cb\u30e5\u30fc\u30b9\u306e\u8cfc\u8aad<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>\u3053\u306e\u30d6\u30ed\u30b0\u8a18\u4e8b\u306e\u4e00\u90e8\u306f\u3001<a href=\"https:\/\/journalforclinicalstudies.com\/scientific-and-ethical-issues-surrounding-the-enrolment-of-pregnant-people-in-clinical-trials\/\" target=\"_blank\" rel=\"noopener\">Journal for Clinical Studies<\/a>, Volume 13 (Issue 5) \u306b\u63b2\u8f09\u3055\u308c\u305f\u3082\u306e\u3067\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8 \u672c\u8a18\u4e8b\u306f\u82f1\u6587\u30d6\u30ed\u30b0\u3092\u65e5\u672c\u8a9e\u306b\u7ffb\u8a33\u518d\u7de8\u96c6\uff08\u4e00\u90e8\u8ffd\u8a18\u3092\u542b\u3080\uff09\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u8a18\u4e8b\u306e\u6b63\u5f0f\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3042\u308a\u3001\u305d\u306e\u5185\u5bb9\u30fb\u89e3\u91c8\u306b\u3064\u3044\u3066\u306f\u82f1\u8a9e\u304c\u512a\u5148\u3057\u307e\u3059\u3002 &nbsp; \u533b\u85ac\u54c1\u306e\u958b\u767a\u8005\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3068\u598a\u5a20\u306b\u95a2\u3057\u3066\u3057\u3070\u3057\u3070\u30b8\u30ec\u30f3\u30de\u306b\u76f4\u9762\u3057\u307e\u3059\u3002 \u81e8\u5e8a\u8a66\u9a13\u306b\u53c2\u52a0\u3057\u305f\u304f\u306a\u3044\u3001\u3042\u308b\u3044\u306f\u53c2\u52a0\u3067\u304d\u306a\u3044\u53ef\u80fd\u6027\u306e\u3042\u308b\u96c6\u56e3\u3067\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u306f\u3001\u3069\u306e\u7a0b\u5ea6\u5b9f\u73fe\u53ef\u80fd\u306a\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u6700\u8fd1\u306e\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306e\u4f1a\u8b70\u306e\u7d50\u679c\u3068\u305d\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6848\u3092\u898b\u3066\u3001\u3088\u308a\u8a73\u7d30\u306a\u60c5\u5831\u3092\u5f97\u307e\u3057\u3087\u3046\u3002 &nbsp; 2021\u5e7411\u6708\u306e\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306e\u4f1a\u8b70\u3067\u3082\u3001\u5c02\u9580\u5bb6\u305f\u3061\u306f\u3053\u306e\u81e8\u5e8a\u8a66\u9a13\u3068\u598a\u5a20\u3068\u3044\u3046\u30c6\u30fc\u30de\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002 \u6297\u83cc\u85ac\u8aee\u554f\u59d4\u54e1\u4f1a\u306f\u3001\u91cd\u5ea6\u306eCOVID-19\u304a\u3088\u3073\/\u307e\u305f\u306f\u5165\u9662\u306b\u9032\u884c\u3059\u308b\u30ea\u30b9\u30af\u306e\u3042\u308b\u6210\u4eba\u306b\u304a\u3051\u308b\u8efd\u5ea6\u304b\u3089\u4e2d\u7a0b\u5ea6\u306eCOVID-19\u306e\u6cbb\u7642\u306b\u5bfe\u3059\u308b\u30e1\u30eb\u30af\u793e\u306e\u30e2\u30eb\u30cc\u30d4\u30e9\u30d3\u30eb\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u50c5\u5dee\u3067\u652f\u6301\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u4f1a\u8b70\u306b\u5148\u7acb\u3061\u3001FDA\u306f\u30e2\u30eb\u30cc\u30d4\u30e9\u30d3\u30eb\u306e\u5909\u7570\u539f\u6027\u3001\u80da\u30fb\u80ce\u5150\u6bd2\u6027\u3001\u9aa8\u30fb\u8edf\u9aa8\u6210\u9577\u969c\u5bb3\u306a\u3069\u306e\u975e\u81e8\u5e8a\u6240\u898b\uff08\u52d5\u7269\u8a66\u9a13\uff09\u3092\u5f37\u8abf\u3057\u307e\u3057\u305f\u3002\u30d1\u30cd\u30ea\u30b9\u30c8\u306f\u3001\u598a\u5a20\u4e2d\u306e\u672c\u5264\u306e\u4f7f\u7528\u306e\u53ef\u80fd\u6027\u306b\u3064\u3044\u3066\u8b70\u8ad6\u3059\u308b\u3088\u3046\u6c42\u3081\u3089\u308c\u307e\u3057\u305f\u3002 11\u6708\u306e\u4f1a\u8b70\u3067FDA\u306e\u5be9\u67fb\u5b98\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u85ac\u5264\u306e\u30ea\u30b9\u30af\u8efd\u6e1b\u7b56\u306e1\u3064\u306f\u3001\u598a\u5a20\u4e2d\u306e\u4f7f\u7528\u3092\u8a31\u53ef\u3057\u306a\u3044\u3053\u3068\u3067\u3042\u308b\u3068\u8ff0\u3079\u307e\u3057\u305f\u3002\u3053\u306e\u65b9\u6cd5\u306f\u3001\u598a\u5a20\u4e2d\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u304c\u30ea\u30b9\u30af\u3092\u4e0a\u56de\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u81e8\u5e8a\u30b7\u30ca\u30ea\u30aa\u304c\u306a\u3044\u5834\u5408\u306b\u9069\u5207\u3067\u3042\u308b\u3068\u3001FDA\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002 &nbsp; \u3088\u308a\u9650\u5b9a\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u3057\u3066\u306f\u3001\u598a\u5a20\u4e2d\u306e\u4f7f\u7528\u3092\u63a8\u5968\u3057\u306a\u3044\u3053\u3068\u3067\u3059\u304c\u3001\u598a\u5a20\u306f\u8a8d\u53ef\u3055\u308c\u305f\u4f7f\u7528\u306e\u5236\u9650\u3068\u306f\u307f\u306a\u3055\u308c\u307e\u305b\u3093\u3002\u598a\u5a20\u4e2d\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u304c\u30ea\u30b9\u30af\u3092\u4e0a\u56de\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u7279\u5b9a\u306e\u81e8\u5e8a\u30b7\u30ca\u30ea\u30aa\u306b\u304a\u3044\u3066\u306f\u3001\u51e6\u65b9\u8005\u306e\u88c1\u91cf\u3067\u598a\u5a20\u4e2d\u306b\u672c\u5264\u3092\u51e6\u65b9\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\u3002 &nbsp; \u598a\u5a20\u4e2d\u306e\u533b\u85ac\u54c1\u4f7f\u7528\uff1a\u30ea\u30b9\u30af\u3068\u306e\u30d0\u30e9\u30f3\u30b9 FDA\u306f\u6700\u8fd1\u306e\u6d3b\u52d5\u306e\u4e2d\u3067\u3001\u8868\u793a\u3084\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u306e\u5224\u65ad\u306b\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306e\u30c7\u30fc\u30bf\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3057\u3001\u598a\u5a20\u4e2d\u304a\u3088\u3073\u6388\u4e73\u4e2d\u306e\u4eba\u3005\u306e\u7814\u7a76\u3092\u4fc3\u9032\u3059\u308b\u3053\u3068\u306b\u30b3\u30df\u30c3\u30c8\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u307e\u3057\u305f\u3002FDA\u306f\u3001\u3053\u306e\u305f\u3081\u306bDuke University Robert J. Margolis Center for Health Policy\u3068\u5354\u529b\u3057\u3001\u533b\u85ac\u54c1\u958b\u767a\u306e\u305f\u3081\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u598a\u5a20\u4e2d\u306e\u4eba\u3092\u767b\u9332\u3059\u308b\u3053\u3068\u306b\u95a2\u9023\u3059\u308b\u79d1\u5b66\u7684\u30fb\u502b\u7406\u7684\u554f\u984c\u306b\u3064\u3044\u30662021\u5e742\u6708\u306b\u516c\u958b\u4f1a\u8b70\u3092\u958b\u50ac\u3057\u307e\u3057\u305f\u3002 &nbsp; \u7c73\u56fd\u4fdd\u5065\u793e\u4f1a\u798f\u7949\u7701\u306f\u3001\u300cFederal Policy for Protection of Human Research&#8230;<\/p>\n","protected":false},"author":161,"featured_media":2675,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1297,1300,1228],"tags":[],"class_list":["post-5278","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-cortellis","category-life-sciences-healthcare","clarivate-industry-life-sciences-and-healthcare","clarivate-product-biopharma"],"acf":[],"lang":"ja","translations":{"ja":5278},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/5278","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/161"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=5278"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/5278\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/2675"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=5278"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=5278"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=5278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}