{"id":8151,"date":"2020-07-30T09:21:34","date_gmt":"2020-07-30T09:21:34","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8151"},"modified":"2020-07-30T09:30:15","modified_gmt":"2020-07-30T09:30:15","slug":"the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/","title":{"rendered":"COVID-19\u304c\u81e8\u5e8a\u8a66\u9a13\u306b\u4e0e\u3048\u308b\u5f71\u97ff\uff1a\u8ab2\u984c\u3068\u6a5f\u4f1a"},"content":{"rendered":"<p><span style=\"font-weight: 400;\"><b><i>\u3053\u306e\u8a18\u4e8b\u3067\u306f\u00a0<a href=\"https:\/\/kolabtree.com\/services\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid19ClinicalTrials\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0for Kolabtree\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/laura-moro\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid19ClinicalTrials\">\u30ed\u30fc\u30e9\u30fb\u30e2\u30ed\u30fb\u30de\u30fc\u30c6\u30a3\u30f3<\/a>MSc, PhD\uff09\u304c\u3001COVID-19\u304c\u81e8\u5e8a\u8a66\u9a13\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u306b\u3064\u3044\u3066\u8a9e\u3063\u3066\u3044\u307e\u3059\u3002\u00a0<\/i><\/b><\/span><\/p>\n<p>\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u611f\u67d3\u75c72019\uff08COVID-19\uff09\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306f\u3001\u4e16\u754c\u4e2d\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3084\u533b\u7642\u63d0\u4f9b\u306b\u9593\u9055\u3044\u306a\u304f\u7834\u58ca\u7684\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u3066\u3044\u307e\u3059\u3002\u591a\u304f\u306e\u56fd\u3067\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u304c\u5727\u8feb\u3055\u308c\u308b\u3053\u3068\u3067\u3001COVID-19\u306b\u3088\u308b\u76f4\u63a5\u7684\u306a\u6b7b\u4ea1\u7387\u3068\u3001\u4ed6\u306e\u75be\u60a3\u306b\u3088\u308b\u9593\u63a5\u7684\u306a\u6b7b\u4ea1\u7387\u306e\u4e21\u65b9\u304c\u61f8\u5ff5\u3055\u308c\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059[1,2]\u3002\u4f8b\u3048\u3070\u3001COVID-19\u306e\u51fa\u73fe\u306b\u3088\u308a\u3001\u6551\u6025\u642c\u9001\u304c\u5927\u5e45\u306b\u6e1b\u5c11\u3057\u305f\u308a[3]\u3001\u3044\u304f\u3064\u304b\u306e\u30ef\u30af\u30c1\u30f3\u63a5\u7a2e\u30ad\u30e3\u30f3\u30da\u30fc\u30f3\u304c\u4e2d\u6b62\u3055\u308c\u305f\u308a\u3057\u3066\u304a\u308a[4]\u3001\u3053\u308c\u3089\u304c\u9593\u63a5\u7684\u306a\u7f79\u60a3\u7387\u3084\u6b7b\u4ea1\u7387\u306e\u5897\u52a0\u306b\u5bc4\u4e0e\u3057\u3066\u3044\u308b\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/services\/clinical-research-consulting\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid19ClinicalTrials\">\u81e8\u5e8a\u7814\u7a76\u306e\u5b9f\u8df5<\/a> \u3082\u4f8b\u5916\u3067\u306f\u306a\u304f\u3001\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u5f71\u97ff\u3067\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u591a\u5927\u306a\u652f\u969c\u304c\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001COVID-19\u306e\u4e88\u9632\u3084\u6cbb\u7642\u3092\u76f4\u63a5\u76ee\u7684\u3068\u3057\u306a\u3044\u8a66\u9a13\u3084\u3001\u53c2\u52a0\u8005\u306e\u81e8\u5e8a\u73fe\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u5fc5\u8981\u3068\u3059\u308b\u8a66\u9a13\u306b\u7279\u306b\u95a2\u4fc2\u3057\u3066\u3044\u307e\u3059\u3002\u5c0f\u5150\u304c\u3093\u3092\u5bfe\u8c61\u3068\u3057\u305f\u521d\u671f\u6bb5\u968e\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308b\u30b9\u30da\u30a4\u30f3\u306e\u7814\u7a76\u3067\u306f\u3001\u4eba\u54e1\u4e0d\u8db3\u3001\u60a3\u8005\u767b\u9332\u306e\u56f0\u96e3\u3055\uff08\u4e88\u60f3\u3055\u308c\u3066\u3044\u305f\u767b\u9332\u8005\u6570\u304c\u6700\u5927\u306775%\u6e1b\u5c11\u3057\u3001\u9032\u884c\u4e2d\u306e\u8a66\u9a13\u3067\u306f50%\u306e\u52df\u96c6\u304c\u4e2d\u65ad\u3055\u308c\u305f\uff09\u3001\u6cbb\u7642\u7d99\u7d9a\u306e\u554f\u984c\u3001\u8a66\u9a13\u8a55\u4fa1\u306e\u9045\u308c\uff0873%\u306e\u30b1\u30fc\u30b9\u3067\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u6d3b\u52d5\u304c\u5ef6\u671f\u3055\u308c\u305f\uff09\u304c\u5831\u544a\u3055\u308c\u3066\u3044\u307e\u3059[5]\u3002\u7c73\u56fd\u81e8\u5e8a\u816b\u760d\u5b66\u4f1a\u304c32\u306e\u304c\u3093\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u5bfe\u8c61\u306b\u884c\u3063\u305f\u8abf\u67fb\u3067\u306f\u3001\u767b\u9332\u306e\u56f0\u96e3\u3055\uff0860%\u306e\u56de\u7b54\u8005\u304c\u767b\u9332\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306e\u4e2d\u6b62\u3092\u5ba3\u8a00\uff09\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9075\u5b88\u3001\u60a3\u8005\u306e\u8a2a\u554f\u6570\u306e\u6e1b\u5c11\uff0860%\u306e\u56de\u7b54\u8005\uff09\u3001\u30b9\u30bf\u30c3\u30d5\u306e\u9650\u754c\u3001\u88dc\u52a9\u7684\u30b5\u30fc\u30d3\u30b9\u306e\u5229\u7528\u53ef\u80fd\u6027\u306e\u72ed\u3055\uff0850%\u306e\u56de\u7b54\u8005\uff09\u306a\u3069\u3001\u591a\u304f\u306e\u8ab2\u984c\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f [6]\u3002\u304c\u3093\u3084\u305d\u306e\u4ed6\u306e\u91cd\u7be4\u306a\u75be\u60a3\u306e\u60a3\u8005\u3055\u3093\u306b\u3068\u3063\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u53c2\u52a0\u306f\u3001\u4e2d\u6b62\u3067\u304d\u306a\u3044\u6cbb\u7642\u306e\u4e0d\u53ef\u6b20\u306a\u90e8\u5206\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u7d50\u679c\u3068\u3057\u3066\u5831\u544a\u3055\u308c\u305f\u4ed6\u306e\u8ab2\u984c\u306b\u306f\u3001\u8a66\u9a13\u624b\u9806\u306e\u5909\u66f4\u306b\u95a2\u3059\u308b\u30b9\u30dd\u30f3\u30b5\u30fc\u3084CRO\u3068\u306e\u3084\u308a\u3068\u308a\u3084\u3001\u610f\u56f3\u7684\u307e\u305f\u306f\u975e\u610f\u56f3\u7684\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u9038\u8131\u304c\u3042\u308a\u3001\u3053\u308c\u3089\u304c\u79d1\u5b66\u7684\u5b8c\u5168\u6027\u3001\u89e3\u91c8\u3001\u304a\u3088\u3073\u8a66\u9a13\u306e\u7d50\u8ad6\u306b\u53ca\u307c\u3059\u5f71\u97ff\u306f\u4e0d\u660e\u3067\u3059[6]\u3002\u4e00\u90e8\u306e\u8457\u8005\u306f\u3001\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u3088\u3063\u3066\u81e8\u5e8a\u8a66\u9a13\u306b\u5f37\u5236\u7684\u306a\u5909\u5316\u304c\u3082\u305f\u3089\u3055\u308c\u3001\u4f8b\u3048\u3070\u3001\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u306e\u8a2a\u554f\u56de\u6570\u306e\u6e1b\u5c11\u3001\u53c2\u52a0\u8005\u306e\u7cbe\u795e\u7684\u30fb\u8089\u4f53\u7684\u306a\u5065\u5eb7\u72b6\u614b\u306e\u60aa\u5316\u3001\u3055\u3089\u306b\u306f\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3078\u306e\u611f\u67d3\u306a\u3069\u306b\u3088\u308a\u3001\u6cbb\u7642\u306e\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u7d50\u679c\u306b\u652f\u969c\u3092\u304d\u305f\u3059\u53ef\u80fd\u6027\u3092\u8b66\u544a\u3057\u3066\u3044\u307e\u3059[7]\u3002\u305d\u306e\u4e0a\u3001COVID-19\u304c\u81e8\u5e8a\u8a66\u9a13\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u306f\u3001\u6cbb\u7642\u5206\u91ce\u306b\u3088\u3063\u3066\u3070\u3089\u3064\u304d\u304c\u3042\u308a\u307e\u3059\u3002\u3042\u308b\u5831\u544a\u306b\u3088\u308b\u3068\u3001\u53c2\u52a0\u8005\u6570\u306e\u6e1b\u5c11\u306f\u3001\u547c\u5438\u5668\u7cfb\u75be\u60a3\u306e34%\u304b\u3089\u5185\u5206\u6ccc\u7cfb\u75be\u60a3\u306e80%\u306b\u307e\u3067\u53ca\u3073\u3001\u305d\u306e\u4ed6\u306e\u6cbb\u7642\u5206\u91ce\u3067\u306f\u4e2d\u9593\u7684\u306a\u5272\u5408\u3068\u306a\u3063\u3066\u3044\u307e\u3059\uff08\u611f\u67d3\u75c747%\u3001\u816b\u760d48%\u3001\u76ae\u819a\u79d164%\u3001\u795e\u7d4c\u7cfb\u75be\u60a368%\u3001\u5fc3\u8840\u7ba1\u75be\u60a370%\uff09[8]\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09[9]\u306f\uff0cCOVID-19\u5371\u6a5f\u306e\u969b\u306b\uff0c\u60a3\u8005\u3084\u533b\u7642\u5f93\u4e8b\u8005\u306e\u4fdd\u8b77\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u533b\u7642\u88fd\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\uff0c\u4f01\u696d\uff0c\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\uff0c\u65bd\u8a2d\u5be9\u67fb\u59d4\u54e1\u4f1a\u5411\u3051\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868\u3057\u307e\u3057\u305f\uff0e\u540c\u69d8\u306b\uff0c\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u3082\uff0c\u30b9\u30dd\u30f3\u30b5\u30fc\u5411\u3051\u306b\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7ba1\u7406\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3059[10]\uff0e\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u81e8\u5e8a\u7814\u7a76\u306e\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u65b9\u91dd\u3068\u624b\u9806\u306b\u95a2\u3057\u3066\u3001\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306e\u67d4\u8edf\u6027\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001COVID-19\u306e\u75c5\u6c17\u3001\u6e21\u822a\u5236\u9650\u3001\u691c\u75ab\u63aa\u7f6e\u306a\u3069\u306b\u3088\u308b\u3001\u8a66\u9a13\u306e\u898b\u5b66\u3084\u624b\u9806\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u3001\u8a66\u9a13\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3001\u65bd\u8a2d\u30b9\u30bf\u30c3\u30d5\u3001\u30e2\u30cb\u30bf\u30fc\u306e\u5909\u66f4\u306a\u3069\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059[11]\u3002\u5404\u56fd\u306e\u533b\u7642\u6a5f\u95a2\u3067\u306f\u3001\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306b\u88ab\u9a13\u8005\u306e\u5b89\u5168\u3068\u5065\u5eb7\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u69d8\u3005\u306a\u5bfe\u7b56\u3092\u63a1\u7528\u3057\u3066\u304a\u308a\u3001\u3044\u304f\u3064\u304b\u306e\u56fd\u306e\u5bfe\u7b56\u3092\u307e\u3068\u3081\u305f\u6cbb\u9a13\u4f9d\u983c\u8005\u306e\u81e8\u5e8a\u8a66\u9a13\u7ba1\u7406\u3092\u652f\u63f4\u3059\u308b\u30ac\u30a4\u30c9\u304c\u767a\u8868\u3055\u308c\u3066\u3044\u307e\u3059[12]\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Once the main obstacles have been identified \u2212mostly mobility and travel restrictions, lack of adequate technologies and disruptions in supply chains [8]\u2212 COVID-19 may be seen as an opportunity to &#8216;rethink&#8217; clinical trials. Some of the solutions proposed to overcome these challenges [13,14] include moving clinical sites to countries and regions less impacted by COVID-19, virtualization of several aspects of the trial (such as remote consent, remote randomization, and remote data capture and reporting), use of technology to closely monitor patient volume and drug supply to minimize disruptions, creation of synthetic control arms from historical trial data combined with <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u4eba\u5de5\u77e5\u80fd<\/a> algorithms, or offering in-home clinical services. In particular, technology innovation can provide new tools to guarantee the continuity and success of clinical studies during the pandemics. An example of this innovation is a risk-based predictive analytical approach powered by machine learning that can offer predictions and forecasts to support decision-making during clinical operations management [15].<\/span><\/p>\n<p><span style=\"font-weight: 400;\">COVID-19\u306e\u7834\u58ca\u7684\u306a\u52b9\u679c\u306b\u3088\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u65b9\u6cd5\u304c\u5909\u5316\u3057\u3001\u533b\u7642\u306e\u30c7\u30b8\u30bf\u30eb\u5316\u3084\u9769\u65b0\u7684\u306a\u30c4\u30fc\u30eb\u3084\u65b9\u6cd5\u8ad6\u306e\u4f7f\u7528\u304c\u63a8\u9032\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u306f\u660e\u3089\u304b\u3067\u3059\u3002\u3053\u306e\u6df7\u4e71\u3092\u5229\u7528\u3057\u3066\u3001\u60a3\u8005\u3055\u3093\u306e\u4f53\u9a13\u3092\u5411\u4e0a\u3055\u305b\u3001\u5b89\u5168\u3067\u52b9\u679c\u7684\u304b\u3064\u5229\u7528\u3057\u3084\u3059\u3044\u6cbb\u7642\u6cd5\u3092\u5e02\u5834\u306b\u63d0\u4f9b\u3057\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u300d\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><b>\u53c2\u8003\u6587\u732e<\/b><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, et al. (2020) Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study.Lancet Global Heal. doi:10.1016\/S2214-109X(20)30229-1.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Hogan AB, Jewell B, Sherrard-Smith E, Vesga J, Watson OJ, et al. (2020) Report 19: The Potential Impact of the COVID-19 Epidemic on HIV, TB and Malaria in Low and Middle-Income Countries.Imperial College of London.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Lazzerini M, Barbi E, Apicella A, Marchetti F, Cardinale F, et al. (2020) Delayed access or provision of care resulting from fear of COVID-19 in Italy.Lancet Child Adolesc Heal 4: e10-e11. doi:10.1016\/S2352-4642(20)30108-5.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff082020\uff09COVID-19\u304c\u65e5\u5e38\u7684\u306a\u4e88\u9632\u63a5\u7a2e\u6d3b\u52d5\u3092\u963b\u5bb3\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u5c11\u306a\u304f\u3068\u30828,000\u4e07\u4eba\u306e1\u6b73\u672a\u6e80\u306e\u5b50\u3069\u3082\u305f\u3061\u304c\u30b8\u30d5\u30c6\u30ea\u30a2\u3001\u306f\u3057\u304b\u3001\u30dd\u30ea\u30aa\u306a\u3069\u306e\u75c5\u6c17\u306e\u30ea\u30b9\u30af\u306b\u3055\u3089\u3055\u308c\u3066\u3044\u308b\u3001\u3068Gavi\u3001WHO\u3001\u30e6\u30cb\u30bb\u30d5\u304c\u8b66\u544a\u3057\u3066\u3044\u307e\u3059\u3002\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/www.who.int\/news-room\/detail\/22-05-2020-at-least-80-million-children-under-one-at-risk-of-diseases-such-as-diphtheria-measles-and-polio-as-covid-19-disrupts-routine-vaccination-efforts-warn-gavi-who-and-unicef\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67085\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Rubio-San-Simon A, Verd\u00fa-Amor\u00f3s J, Hladun R, Ribelles AJ, Molero M, Guerra-Garc\u00eda P, P\u00e9rez-Mart\u00ednez A, Casta\u00f1eda A, Ca\u00f1ete A, Rojas Td, Moreno L BF (2020) COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306e\u5c0f\u5150\u304c\u3093\u306b\u5bfe\u3059\u308b\u521d\u671f\u6bb5\u968e\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u8ab2\u984c\u3002A Report From the New Agents Group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP).Clin Transl Oncol:1\u20137. doi:10.1007\/S12094-020-02399-3.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Waterhouse DM, Harvey RD, Hurley P, Levit LA, Kim ES, et al. (2020) COVID-19 \u306e\u30aa\u30f3\u30b3\u30ed\u30b8\u30fc\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u5bfe\u3059\u308b\u521d\u671f\u306e\u5f71\u97ff\u3068\u3001\u5909\u9769\u306e\u305f\u3081\u306e\u9577\u671f\u7684\u306a\u6a5f\u4f1a\u3002Findings From an American Society of Clinical Oncology Survey. https:\/\/doi.org\/101200\/OP2000275. doi:10.1200\/OP.20.00275.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Servick K (2020) COVID-19\u4ee5\u5916\u306e\u75c7\u72b6\u3067\u3082\u81e8\u5e8a\u8a66\u9a13\u304c\u9032\u3080\u3002\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u5f71\u97ff\u306f\u5f7c\u3089\u306e\u30c7\u30fc\u30bf\u306b\u5fcd\u3073\u8fbc\u3080\u3060\u308d\u3046\u304b\uff1fScience.\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/www.sciencemag.org\/news\/2020\/05\/clinical-trials-press-conditions-other-covid-19-will-pandemic-s-effects-sneak-their\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67085\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u30e1\u30c7\u30a3\u30c7\u30fc\u30bf (2020) COVID-19 \u3068\u81e8\u5e8a\u8a66\u9a13\u3002\u30e1\u30c7\u30a3\u30c7\u30fc\u30bf\u306e\u8996\u70b9\u304b\u3089\u3002\u30ea\u30ea\u30fc\u30b95.0.\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/www.medidata.com\/en\/insight\/covid-19-and-clinical-trials-the-medidata-perspective\/\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67085\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">US Food and Drug Administration (2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards\uff08COVID-19\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306b\u304a\u3051\u308b\u533b\u7642\u88fd\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308bFDA\u30ac\u30a4\u30c0\u30f3\u30b9\uff09\u3002\u5229\u7528\u53ef\u80fd <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\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67085\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff082020\uff09COVID-19\uff08\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff09\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7ba1\u7406\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3002\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67082\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Sarah Morgan, Liz O'Neil, Karin Parks (2020) Impact of COVID-19 on Clinical Trials\uff08COVID-19\u306e\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u5f71\u97ff\uff09\u3002\u5165\u624b\u53ef\u80fd <a href=\"https:\/\/www.healthwaregroup.com\/blog\/impact-of-covid-19-on-clinical-trials-609\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67082\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">DLA Piper (2020) A guide to managing clinical trials during the COVID-19 pandemic.\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/www.dlapiper.com\/it\/italy\/insights\/publications\/2020\/04\/clinical-trials-during-covid19-pandemic-a-global-guide\/\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67085\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Fareed Melhem (2020) The Global Impact of COVID-19 on Clinical Trials and the Way Forward | Technology Networks.\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/www.technologynetworks.com\/drug-discovery\/blog\/the-global-impact-of-covid-19-on-clinical-trials-and-the-way-forward-333652\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67085\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">ICON plc\uff082020\uff09COVID-19\u306b\u3088\u308b\u5728\u5b85\u81e8\u5e8a\u30b5\u30fc\u30d3\u30b9\u3092\u4f34\u3046\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u5f71\u97ff\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3002\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/www.iconplc.com\/insights\/blog\/2020\/04\/02\/minimise-the-impact-of-covid19-on-clinical-trials-by-considering-in-home-clinical-services\/\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67085\u65e5\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Ben van der Schaaf, Thomas Unger, Michael Eiden, Ben Enejo, Craig Wylie, Tom Teixeira RE (2020) Managing clinical trials during COVID-19 and beyond.\u5229\u7528\u53ef\u80fd <a href=\"https:\/\/www.adlittle.it\/en\/insights\/viewpoints\/managing-clinical-trials-during-covid-19-and-beyond\">\u3053\u308c<\/a>.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e746\u67082\u65e5\u3067\u3059\u3002<\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>In this article\u00a0freelance medical writer\u00a0for Kolabtree\u00a0Laura Moro-Martin, MSc, PhD, discusses the impact of COVID-19 on clinical trials.\u00a0 Coronavirus disease 2019 (COVID-19) pandemic is undoubtedly having a disruptive effect on health systems and healthcare delivery worldwide. The overwhelm of health systems in many countries is predicted to cause a concerning increase in both direct mortality from COVID-19 and indirect mortality from other conditions [1,2]. For example, emergency visits have been substantially reduced [3] and several vaccination campaigns have been halted due to the emergence of COVID-19 [4], which may contribute to the indirect morbidity and mortality. Clinical research practice is no exception, with the pandemic causing tremendous disruptions on ongoing clinical<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8155,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[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>The impact of COVID-19 on clinical trials: challenges and opportunities<\/title>\n<meta name=\"description\" content=\"COVID-19 has shifted the way we conduct clinical trials, pushing towards the digitalization of healthcare and the use of innovative tools and methodologies.\" \/>\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\/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The impact of COVID-19 on clinical trials: challenges and opportunities\" \/>\n<meta property=\"og:description\" content=\"COVID-19 has shifted the way we conduct clinical trials, pushing towards the digitalization of healthcare and the use of innovative tools and methodologies.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" 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