{"id":1706,"date":"2020-10-21T14:25:33","date_gmt":"2020-10-21T05:25:33","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/%e5%8c%bb%e8%96%ac%e5%93%81%e9%96%8b%e7%99%ba%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e3%83%87%e3%82%b8%e3%82%bf%e3%83%ab%e3%82%a4%e3%83%8e%e3%83%99%e3%83%bc%e3%82%b7%e3%83%a7%e3%83%b3%e3%81%af%e4%bb%8a\/?lang=ja"},"modified":"2024-10-24T00:27:01","modified_gmt":"2024-10-24T00:27:01","slug":"is-digital-innovation-in-drug-development-here-to-stay-perspectives-from-pharma-tech-and-regulatory-experts","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/is-digital-innovation-in-drug-development-here-to-stay-perspectives-from-pharma-tech-and-regulatory-experts\/","title":{"rendered":"\u533b\u85ac\u54c1\u958b\u767a\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306f\u4eca\u5f8c\u3082\u7d9a\u304f\u306e\u304b\uff1f"},"content":{"rendered":"<div class=\"float-left mr-3\"><span class=\"author vcard\"><img loading=\"lazy\" decoding=\"async\" class=\"avatar avatar-70 wp-user-avatar wp-user-avatar-70 photo alignleft\" src=\"https:\/\/clarivate.com\/wp-content\/uploads\/sites\/4\/2024\/09\/Francesco-Delissanti-150x150-1.jpg\" alt=\"Francesco Dellisanti\" width=\"70\" height=\"70\" \/><\/span><\/div>\n<div class=\"float-left author-text\">\n<p class=\"author-name text-uppercase mb-2\"><strong>FRANCESCO DELLISANTI<\/strong><\/p>\n<p class=\"author-title mb-0\">Director of Digital Health, Clarivate<\/p>\n<\/div>\n<p>&nbsp;<br \/>\n&nbsp;<br \/>\n&nbsp;<\/p>\n<p><a href=\"https:\/\/clarivate.com\/cortellis\/article\/is-digital-innovation-in-drug-development-here-to-stay-perspectives-from-pharma-tech-and-regulatory-experts\/\">\u82f1\u8a9e\u539f\u6587<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><em>COVID-19<\/em><em>\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u3088\u308a\u3001\u30b9\u30dd\u30f3\u30b5\u30fc<\/em><em>\/CRO<\/em><em>\u3084\u898f\u5236\u5f53\u5c40\u306f\u3001\u73fe\u5728\u9032\u884c\u4e2d\u306e\u8a66\u9a13\u3084\u65b0\u3057\u3044\u8a66\u9a13\u306b\u30d0\u30fc\u30c1\u30e3\u30eb\u3084\u30ea\u30e2\u30fc\u30c8\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u65b9\u6cd5\u3092\u53d6\u308a\u5165\u308c\u308b\u3053\u3068\u3067\u3001\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u5f71\u97ff\u306b\u9069\u5fdc\u3059\u308b\u3053\u3068\u3092\u4f59\u5100\u306a\u304f\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5c0e\u5165\u306f\u6210\u529f\u3057\u305f\u306e\u3067\u3057\u3087\u3046\u304b\u3001\u305d\u3057\u3066\u4eca\u5f8c\u3082\u7d99\u7d9a\u3055\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/em><\/p>\n<p>&nbsp;<\/p>\n<p>\u904e\u53bb2\u5e74\u9593\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u3067\u306f\u3001\u60a3\u8005\u4e2d\u5fc3\u306e\u81e8\u5e8a\u8a66\u9a13\u3084\u767b\u9332\u6570\u306e\u5897\u52a0\u306b\u3088\u308b\u30e1\u30ea\u30c3\u30c8\u3092\u8003\u616e\u3057\u3066\u3001\u30c7\u30b8\u30bf\u30eb\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u304c\u76db\u3093\u306b\u8b70\u8ad6\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u5c0e\u5165\u306f\u6bd4\u8f03\u7684\u9045\u308c\u3066\u3044\u307e\u3059\u3002COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u3092\u304d\u3063\u304b\u3051\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u9060\u9694\u5730\u3067\u6a5f\u80fd\u3055\u305b\u3001\u95a2\u4fc2\u8005\u5168\u54e1\u306e\u611f\u67d3\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u6280\u8853\u306e\u63a1\u7528\u3078\u3068\u6025\u901f\u306b\u30b7\u30d5\u30c8\u3057\u3066\u304d\u307e\u3057\u305f\u3002 \u3053\u308c\u306f\u81e8\u5e8a\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u521d\u671f\u306e\u6df7\u4e71\u3092\u7de9\u548c\u3059\u308b\u3053\u3068\u306b\u8ca2\u732e\u3057\u3066\u304a\u308a\u30012020\u5e744\u6708\u306b\u306f\u4e16\u754c\u5168\u4f53\u3067\u6628\u5e74\u3068\u6bd4\u8f03\u3057\u3066\u65b0\u898f\u8a66\u9a13\u958b\u59cb\u6570\u304c30\uff05\u6e1b\u5c11\u3057\u30011\u65bd\u8a2d\u3042\u305f\u308a\u306e\u5e73\u5747\u65b0\u898f\u60a3\u8005\u6570\u304c70\uff05\u6e1b\u5c11\u3057\u3066\u3044\u307e\u3059<sup>1<\/sup>\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p>2020\u5e744\u6708\u306b\u306f\u30011\u65bd\u8a2d\u3042\u305f\u308a\u306e\u6cbb\u9a13\u306b\u5165\u308b\u65b0\u898f\u60a3\u8005\u306e\u5e73\u5747\u6570\u304c70\uff05\u3082\u6e1b\u5c11\u3057\u3066\u3044\u307e\u3059\u3002<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>\u6700\u8fd1\u958b\u50ac\u3055\u308c\u305f\u30e9\u30a6\u30f3\u30c9\u30c6\u30fc\u30d6\u30eb\u3067\u306f\u3001\u30af\u30e9\u30ea\u30d9\u30a4\u30c8\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u90e8\u9580\u30de\u30fc\u30b1\u30c3\u30c8\u6226\u7565\u62c5\u5f53\u30b7\u30cb\u30a2\u30d0\u30a4\u30b9\u30d7\u30ec\u30b8\u30c7\u30f3\u30c8\u306e<strong>Joel Haspel<\/strong>\u3001\u5143\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u7b2c23\u4ee3\u30b3\u30df\u30c3\u30b7\u30e7\u30ca\u30fc\u306e<strong>Scott Gottlieb<\/strong>\u535a\u58eb\u3001BMS\u306e\u30d0\u30a4\u30b9\u30d7\u30ec\u30b8\u30c7\u30f3\u30c8\u517c\u30b0\u30ed\u30fc\u30d0\u30eb\u30c7\u30b8\u30bf\u30eb\u6226\u7565\u8cac\u4efb\u8005\u306e<strong>Shwen Gwee<\/strong>\u6c0f\u304c\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u30c4\u30fc\u30eb\u306e\u4f7f\u7528\u3068\u6210\u529f\u3001\u304a\u3088\u3073\u305d\u308c\u3089\u3092\u5c0e\u304f\u898f\u5236\u4e0a\u306e\u67a0\u7d44\u307f\u306b\u3064\u3044\u3066\u8b70\u8ad6\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u306e\u73fe\u72b6<\/strong><\/h3>\n<p>\u30c7\u30b8\u30bf\u30eb\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u5229\u70b9\u306b\u306f\u3001\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u53ce\u96c6\u3001\u7d99\u7d9a\u7684\u306a\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u304b\u3089\u306e\u6d1e\u5bdf\u3001\u60a3\u8005\u4e2d\u5fc3\u4e3b\u7fa9\u306e\u5f37\u5316\u306b\u3088\u308b\u63a1\u7528\u3068\u5b9a\u7740\u7387\u306e\u5411\u4e0a\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30d0\u30fc\u30c1\u30e3\u30eb\u307e\u305f\u306f\u30ea\u30e2\u30fc\u30c8\u3067\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u3088\u308a\u591a\u304f\u306e\u591a\u69d8\u306a\u4eba\u3005\u306b\u81e8\u5e8a\u8a66\u9a13\u3092\u62e1\u5927\u3059\u308b\u6a5f\u4f1a\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u304c\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u306e\u80fd\u529b\u3092\u6d3b\u7528\u3057\u59cb\u3081\u305f\u306e\u306f\u5f53\u7136\u306e\u3053\u3068\u3067\u3059\u3002<\/p>\n<p>\u904e\u53bb9\u5e74\u9593\u3067\u3001\u30d0\u30fc\u30c1\u30e3\u30eb\u8a66\u9a13\u3084\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u8a66\u9a13\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u4ecb\u5165\u8a66\u9a13\u306a\u3069\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u306b\u95a2\u9023\u3059\u308b\u8a66\u9a13\u304c13,000\u4ef6\u78ba\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6570\u306f\u904e\u53bb5\u5e74\u9593\u306740%\u5897\u52a0\u3057\u3066\u304a\u308a\u3001\u6700\u8fd1\u306e\u4e88\u6e2c\u306b\u3088\u308b\u3068\u30012025\u5e74\u307e\u3067\u306b\u81e8\u5e8a\u8a66\u9a13\u306e70%\u306b\u30c7\u30b8\u30bf\u30eb\u30bb\u30f3\u30b5\u30fc\u304c\u7d44\u307f\u8fbc\u307e\u308c\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059<sup>2<\/sup>\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p>\u904e\u53bb9\u5e74\u9593\u306713,000\u4ef6\u306e\u81e8\u5e8a\u8a66\u9a13\u304c\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u306e\u4f7f\u7528\u306b\u8a00\u53ca\u3057\u3066\u3044\u307e\u3059\u3002<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u3092\u30c7\u30b8\u30bf\u30eb\u5316\u3059\u308b\u305f\u3081\u306b\u3001\u3053\u3053\u6570\u5341\u5e74\u306e\u9593\u306b\u304b\u306a\u308a\u306e\u8a66\u307f\u304c\u884c\u308f\u308c\u3066\u304d\u307e\u3057\u305f\u304c\u3001\u5b9f\u969b\u306b\u63a1\u7528\u3092\u5f8c\u62bc\u3057\u3057\u305f\u306e\u306f\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\u306e\u666e\u53ca\u3068\u30c7\u30b8\u30bf\u30eb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001Apple 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1\u30ce\u30a4\u30ba\u304b\u3089\u4fe1\u53f7\u3092\u5206\u96e2\u3059\u308b\u305f\u3081\u306e\u4ed6\u306e\u30c4\u30fc\u30eb\u306a\u3069\u3001\u30c7\u30fc\u30bf\u3092\u3069\u306e\u3088\u3046\u306b\u6d3b\u7528\u3059\u308b\u304b\u306b\u9769\u65b0\u306e\u6a5f\u4f1a\u304c\u5b58\u5728\u3057\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u79c1\u305f\u3061\u306f\u307e\u3060\u305d\u3053\u307e\u3067\u306b\u306f\u81f3\u3063\u3066\u3044\u307e\u305b\u3093\u3002\u591a\u304f\u306e\u30c7\u30b8\u30bf\u30eb\u30c4\u30fc\u30eb\u306f\u3001\u307e\u3060\u4eba\u9593\u3068\u306e\u5bfe\u8a71\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u3088\u308b\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u306e\u63a8\u9032<\/strong><\/h3>\n<p>\u30c7\u30b8\u30bf\u30eb\u30c8\u30e9\u30f3\u30b9\u30d5\u30a9\u30fc\u30e1\u30fc\u30b7\u30e7\u30f3\u3092\u5b9f\u73fe\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u3053\u306e\u6025\u901f\u306b\u5909\u5316\u3059\u308b\u74b0\u5883\u306b\u9045\u308c\u3092\u53d6\u3089\u306a\u3044\u3088\u3046\u306b\u3001\u696d\u754c\u95a2\u4fc2\u8005\u304c\u983b\u7e41\u306b\u5354\u529b\u3057\u5408\u3044\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u53d6\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u3067\u4f7f\u7528\u3059\u308b\u305f\u3081\u306e\u5404\u30c7\u30b8\u30bf\u30eb\u30c7\u30d0\u30a4\u30b9\u3084\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u691c\u8a3c\u3059\u308b\u8cac\u4efb\uff08\u3068\u8cbb\u7528\uff09\u306f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u3042\u308a\u307e\u3059\u3002\u6cbb\u9a13\u4f9d\u983c\u8005\u306b\u306f\u3001\u7e70\u308a\u8fd4\u3057\u4f7f\u7528\u3067\u304d\u308b\u30c4\u30fc\u30eb\u306e\u305f\u3081\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u30d7\u30fc\u30eb\u3059\u308b\u6a5f\u4f1a\u304c\u3042\u308a\u307e\u3059\u3002\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u30a2\u30c3\u30bb\u30a4\u306e\u5171\u540c\u7814\u7a76\u306f\u3001\u91cd\u8907\u3059\u308b\u4f5c\u696d\u3092\u6e1b\u3089\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u3067\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u4f7f\u7528\u3092\u52a0\u901f\u3055\u305b\u307e\u3057\u305f\u3002\u3055\u3089\u306b\u3001\u3053\u306e\u7814\u7a76\u306f\u88fd\u85ac\u4f01\u696d\u3060\u3051\u306b\u9650\u5b9a\u3055\u308c\u308b\u5fc5\u8981\u306f\u306a\u304f\u3001\u5b9f\u969b\u306b\u88fd\u85ac\u4f01\u696d\u3068\u30cf\u30a4\u30c6\u30af\u4f01\u696d\u306e\u9593\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30fb\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u304c\u3001\u53cc\u65b9\u306e\u30ae\u30e3\u30c3\u30d7\u306e\u4e00\u90e8\u3092\u57cb\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p>\u30c7\u30b8\u30bf\u30eb\u30c8\u30e9\u30f3\u30b9\u30d5\u30a9\u30fc\u30e1\u30fc\u30b7\u30e7\u30f3\u306b\u5230\u9054\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>\u307e\u305f\u3001\u6570\u3082\u529b\u3068\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u696d\u754c\u306e\u30b3\u30f3\u30bd\u30fc\u30b7\u30a2\u30e0\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306b\u6311\u6226\u3057\u3001\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u3084\u898f\u5236\u306e\u5fc5\u8981\u6027\u3092\u751f\u307f\u51fa\u3059\u3053\u3068\u3067\u3001\u898f\u5236\u74b0\u5883\u306e\u5909\u5316\u3092\u523a\u6fc0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19\u306f\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u30fb\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u52a0\u901f\u3055\u305b\u3066\u304d\u307e\u3057\u305f\u304c\u3001\u79c1\u305f\u3061\u306b\u306f\u3053\u306e\u52e2\u3044\u3092\u7d99\u7d9a\u3057\u3001\u3088\u308a\u52b9\u7387\u7684\u306a\u8a66\u9a13\u3068\u3088\u308a\u826f\u3044\u60a3\u8005\u306e\u8ee2\u5e30\u304b\u3089\u5229\u76ca\u3092\u5f97\u308b\u6a5f\u4f1a\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u306e\u672a\u6765\u3092\u7406\u89e3\u3059\u308b\u6e96\u5099\u306f\u3067\u304d\u3066\u3044\u307e\u3059\u304b\uff1f<\/strong><\/h3>\n<p>\u3053\u306e\u8b70\u8ad6\u3068\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u30c4\u30fc\u30eb\u306e\u5c0e\u5165\u306e\u6210\u529f\u306f\u3001\u958b\u767a\u306e\u3042\u3089\u3086\u308b\u5074\u9762\u306b\u308f\u305f\u3063\u3066\u3044\u307e\u3059\u3002Cortellis\u306f\u3001\u3042\u3089\u3086\u308b\u6bb5\u968e\u3067\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306e\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3068\u5206\u6790\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u308c\u304c\u3001<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/digital-health-intelligence-analytics\/\">Cortellis Digital Health Intelligence\u2122<\/a>\u3001<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Clinical Regulatory Intelligence\u2122<\/a>\u3001<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/trials-intelligence-analytics\/\">Clinical Trials Intelligence\u2122<\/a>\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>References<\/strong><\/h4>\n<ol>\n<li>Cortellis Clinical Trials Intelligence<\/li>\n<li>Jansen Y, Thornton G. Wearables &amp; Big Data In Clinical Trials \u2014 Where Do We Stand? Clinical Leader. February 25, 2020. Available at https:\/\/www.clinicalleader.com\/doc\/wearables-big-data-in-clinical-trials-where-do-we-stand-0001<\/li>\n<li>FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. Available at <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency<\/a><\/li>\n<li>Managing clinical trials during Coronavirus (COVID-19). Available at <a href=\"https:\/\/www.gov.uk\/guidance\/managing-clinical-trials-during-coronavirus-covid-19\" target=\"_blank\" rel=\"noopener\">https:\/\/www.gov.uk\/guidance\/managing-clinical-trials-during-coronavirus-covid-19<\/a><\/li>\n<li>Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. Available at <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf<\/a><\/li>\n<li>FDA Digital Health Innovation Action Plan. Available at <a href=\"https:\/\/www.fda.gov\/media\/106331\/download\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/media\/106331\/download<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>FRANCESCO DELLISANTI Director of Digital Health, Clarivate &nbsp; &nbsp; &nbsp; \u82f1\u8a9e\u539f\u6587 &nbsp; COVID-19\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u3088\u308a\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\/CRO\u3084\u898f\u5236\u5f53\u5c40\u306f\u3001\u73fe\u5728\u9032\u884c\u4e2d\u306e\u8a66\u9a13\u3084\u65b0\u3057\u3044\u8a66\u9a13\u306b\u30d0\u30fc\u30c1\u30e3\u30eb\u3084\u30ea\u30e2\u30fc\u30c8\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u65b9\u6cd5\u3092\u53d6\u308a\u5165\u308c\u308b\u3053\u3068\u3067\u3001\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u5f71\u97ff\u306b\u9069\u5fdc\u3059\u308b\u3053\u3068\u3092\u4f59\u5100\u306a\u304f\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5c0e\u5165\u306f\u6210\u529f\u3057\u305f\u306e\u3067\u3057\u3087\u3046\u304b\u3001\u305d\u3057\u3066\u4eca\u5f8c\u3082\u7d99\u7d9a\u3055\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f &nbsp; \u904e\u53bb2\u5e74\u9593\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u3067\u306f\u3001\u60a3\u8005\u4e2d\u5fc3\u306e\u81e8\u5e8a\u8a66\u9a13\u3084\u767b\u9332\u6570\u306e\u5897\u52a0\u306b\u3088\u308b\u30e1\u30ea\u30c3\u30c8\u3092\u8003\u616e\u3057\u3066\u3001\u30c7\u30b8\u30bf\u30eb\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u304c\u76db\u3093\u306b\u8b70\u8ad6\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u5c0e\u5165\u306f\u6bd4\u8f03\u7684\u9045\u308c\u3066\u3044\u307e\u3059\u3002COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u3092\u304d\u3063\u304b\u3051\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u9060\u9694\u5730\u3067\u6a5f\u80fd\u3055\u305b\u3001\u95a2\u4fc2\u8005\u5168\u54e1\u306e\u611f\u67d3\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u6280\u8853\u306e\u63a1\u7528\u3078\u3068\u6025\u901f\u306b\u30b7\u30d5\u30c8\u3057\u3066\u304d\u307e\u3057\u305f\u3002 \u3053\u308c\u306f\u81e8\u5e8a\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u521d\u671f\u306e\u6df7\u4e71\u3092\u7de9\u548c\u3059\u308b\u3053\u3068\u306b\u8ca2\u732e\u3057\u3066\u304a\u308a\u30012020\u5e744\u6708\u306b\u306f\u4e16\u754c\u5168\u4f53\u3067\u6628\u5e74\u3068\u6bd4\u8f03\u3057\u3066\u65b0\u898f\u8a66\u9a13\u958b\u59cb\u6570\u304c30\uff05\u6e1b\u5c11\u3057\u30011\u65bd\u8a2d\u3042\u305f\u308a\u306e\u5e73\u5747\u65b0\u898f\u60a3\u8005\u6570\u304c70\uff05\u6e1b\u5c11\u3057\u3066\u3044\u307e\u30591\u3002 &nbsp; 2020\u5e744\u6708\u306b\u306f\u30011\u65bd\u8a2d\u3042\u305f\u308a\u306e\u6cbb\u9a13\u306b\u5165\u308b\u65b0\u898f\u60a3\u8005\u306e\u5e73\u5747\u6570\u304c70\uff05\u3082\u6e1b\u5c11\u3057\u3066\u3044\u307e\u3059\u3002 &nbsp; \u6700\u8fd1\u958b\u50ac\u3055\u308c\u305f\u30e9\u30a6\u30f3\u30c9\u30c6\u30fc\u30d6\u30eb\u3067\u306f\u3001\u30af\u30e9\u30ea\u30d9\u30a4\u30c8\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u90e8\u9580\u30de\u30fc\u30b1\u30c3\u30c8\u6226\u7565\u62c5\u5f53\u30b7\u30cb\u30a2\u30d0\u30a4\u30b9\u30d7\u30ec\u30b8\u30c7\u30f3\u30c8\u306eJoel Haspel\u3001\u5143\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u7b2c23\u4ee3\u30b3\u30df\u30c3\u30b7\u30e7\u30ca\u30fc\u306eScott Gottlieb\u535a\u58eb\u3001BMS\u306e\u30d0\u30a4\u30b9\u30d7\u30ec\u30b8\u30c7\u30f3\u30c8\u517c\u30b0\u30ed\u30fc\u30d0\u30eb\u30c7\u30b8\u30bf\u30eb\u6226\u7565\u8cac\u4efb\u8005\u306eShwen Gwee\u6c0f\u304c\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u30c4\u30fc\u30eb\u306e\u4f7f\u7528\u3068\u6210\u529f\u3001\u304a\u3088\u3073\u305d\u308c\u3089\u3092\u5c0e\u304f\u898f\u5236\u4e0a\u306e\u67a0\u7d44\u307f\u306b\u3064\u3044\u3066\u8b70\u8ad6\u3057\u307e\u3057\u305f\u3002 &nbsp; &nbsp; \u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u306e\u73fe\u72b6 \u30c7\u30b8\u30bf\u30eb\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u5229\u70b9\u306b\u306f\u3001\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u53ce\u96c6\u3001\u7d99\u7d9a\u7684\u306a\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u304b\u3089\u306e\u6d1e\u5bdf\u3001\u60a3\u8005\u4e2d\u5fc3\u4e3b\u7fa9\u306e\u5f37\u5316\u306b\u3088\u308b\u63a1\u7528\u3068\u5b9a\u7740\u7387\u306e\u5411\u4e0a\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30d0\u30fc\u30c1\u30e3\u30eb\u307e\u305f\u306f\u30ea\u30e2\u30fc\u30c8\u3067\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u3088\u308a\u591a\u304f\u306e\u591a\u69d8\u306a\u4eba\u3005\u306b\u81e8\u5e8a\u8a66\u9a13\u3092\u62e1\u5927\u3059\u308b\u6a5f\u4f1a\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u304c\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u306e\u80fd\u529b\u3092\u6d3b\u7528\u3057\u59cb\u3081\u305f\u306e\u306f\u5f53\u7136\u306e\u3053\u3068\u3067\u3059\u3002 \u904e\u53bb9\u5e74\u9593\u3067\u3001\u30d0\u30fc\u30c1\u30e3\u30eb\u8a66\u9a13\u3084\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u8a66\u9a13\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u4ecb\u5165\u8a66\u9a13\u306a\u3069\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u306b\u95a2\u9023\u3059\u308b\u8a66\u9a13\u304c13,000\u4ef6\u78ba\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6570\u306f\u904e\u53bb5\u5e74\u9593\u306740%\u5897\u52a0\u3057\u3066\u304a\u308a\u3001\u6700\u8fd1\u306e\u4e88\u6e2c\u306b\u3088\u308b\u3068\u30012025\u5e74\u307e\u3067\u306b\u81e8\u5e8a\u8a66\u9a13\u306e70%\u306b\u30c7\u30b8\u30bf\u30eb\u30bb\u30f3\u30b5\u30fc\u304c\u7d44\u307f\u8fbc\u307e\u308c\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u30592\u3002 &nbsp; 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