{"id":342,"date":"2019-03-17T11:41:46","date_gmt":"2019-03-17T02:41:46","guid":{"rendered":"https:\/\/info.zanet.biz\/?p=342"},"modified":"2019-03-18T06:44:15","modified_gmt":"2019-03-17T21:44:15","slug":"ema-benefit-risk-methodology","status":"publish","type":"post","link":"https:\/\/info.zanet.biz\/?p=342","title":{"rendered":"EMA\u306eBenefit-risk methodology"},"content":{"rendered":"\n<p>EMA\u306f<a href=\"https:\/\/www.ema.europa.eu\/en\">European Medicines Agency \uff08\u6b27\u5dde\u533b\u85ac\u54c1\u5c40\uff09<\/a>\u306e\u3053\u3068\u3067\u3001European Union (EU)\u6b27\u5dde\u9023\u5408\u306e\u533b\u85ac\u54c1\u898f\u5236\u5f53\u5c40\u3067\u3059\u3002EMA\u306f\u533b\u85ac\u54c1\u306e\u8a31\u8a8d\u53ef\u306e\u969b\u306bBenefits\u304cRisks\u3092\u4e0a\u56de\u308b\u304b\u3069\u3046\u304b\u3092\u5be9\u67fb\u3057\u307e\u3059\u3002\u6b21\u306e\u3088\u3046\u306b\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059:&#8221;The European Medicines Agency&#8217;s opinions are based on balancing the desired effects or &#8216;benefits&#8217; of a medicine against its undesired effects or &#8216;risks&#8217;. The Agency can recommend the authorisation of a medicine whose <strong>benefits are judged to be greater than its risks<\/strong>. In contrast, a medicine whose risks outweigh its benefits cannot be recommended for marketing.&#8221;\u3059\u306a\u308f\u3061\u3001\u201d\u533b\u85ac\u54c1\u306e\u671b\u307e\u3057\u3044\u52b9\u679c=Benefits\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u304c\u305d\u306e\u671b\u307e\u3057\u304f\u306a\u3044\u52b9\u679c=Risks\u30ea\u30b9\u30af\u3088\u308a\u5927\u304d\u3044\u3068\u5224\u65ad\u3055\u308c\u305f\u6642\u306b\u8a8d\u53ef\u3092\u63a8\u5968\u3059\u308b\u201d\u3068\u306e\u3053\u3068\u3067\u3059\u3002<\/p>\n\n\n\n<p>EMA\u306f\u533b\u85ac\u54c1\u306ebenefits\u3068risks\u306e\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u3088\u308a\u4e00\u5b9a\u3057\u305f\u3001\u3088\u308a\u900f\u660e\u6027\u306e\u9ad8\u3044\u3001\u5be9\u67fb\u304c\u3088\u308a\u5bb9\u6613\u306a\u3082\u306e\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u5f53\u5c40\u306e\u4f5c\u696d\u306e\u4e2d\u3067\u4f7f\u7528\u3067\u304d\u308b\u3001Decision-making model\u6c7a\u65ad\u30e2\u30c7\u30eb\uff08\u610f\u601d\u6c7a\u5b9a\u30e2\u30c7\u30eb\uff09\u3092\u898b\u3064\u3051\u308b\u305f\u3081\u306eBenefit-risk methodology project\u30922009\u5e74\u306b\u958b\u59cb\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u7d50\u679c\u30925\u3064\u306e<a href=\"https:\/\/www.ema.europa.eu\/en\/about-us\/support-research\/benefit-risk-methodology\">Work package<\/a>\u3068\u3057\u3066\u516c\u958b\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u3053\u308c\u3089\u306f<a href=\"https:\/\/www.ema.europa.eu\/en\/committees\/committee-medicinal-products-human-use-chmp\">The Committee for Medicinal Products for Human Use (CHMP) \u6b27\u5dde\u533b\u85ac\u54c1\u5e81\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u59d4\u54e1\u4f1a<\/a>\u306e\u898b\u89e3\u3092\u4ee3\u8868\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u7814\u7a76\u3042\u308b\u3044\u306f\u4e00\u3064\u306e\u4f8b\u3068\u3057\u3066\u53d6\u308a\u6271\u3046\u3079\u304d\u3053\u3068\u304c\u514d\u8cac\u6761\u9805\u3067\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>Work packge 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network\u3092\u898b\u308b\u3068\u30012009\u5e74\u306b\u30015\u304b\u56fd\u306e\u898f\u5236\u5f53\u5c40\u306e42\u540d\u306e\u30ad\u30fc\u30d1\u30fc\u30bd\u30f3\u306b\u30a4\u30f3\u30bf\u30d3\u30e5\u30fc\u3092\u3057\u3066\u5f53\u6642\u306e\u73fe\u72b6\u306e\u8abf\u67fb\u3092\u3057\u3066\u3044\u307e\u3059\u3002\u30a4\u30f3\u30bf\u30d3\u30e5\u30fc\u306e\u9805\u76ee\u306e\u4e2d\u306b\u306f\u3001Benefits\u3001Risks\u306e\u7406\u89e3\u3001Benefit-risk assessment\u306e\u30d7\u30ed\u30bb\u30b9\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u30a4\u30f3\u30bf\u30d3\u30e5\u30fc\u306e\u7d50\u679c\u3001\u5168\u54e1\u304c\u201dBenefit-risk balance\u306f\u5c02\u9580\u5bb6\u306e\u5224\u65ad\u306b\u3088\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u8a31\u8a8d\u53ef\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u6700\u3082\u96e3\u3057\u3044\u30b9\u30c6\u30c3\u30d7\u3067\u3042\u308b\u201d\u3053\u3068\u3092\u8a8d\u3081\u3001&#8221;The benefit-risk balance is assessed mainly intuitively, the responsibility of an accountable senior assessor in some agencies or of a group in other agencies, as a result of extensive discussion. &#8220;\u3068\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u3053\u306e\u6642\u70b9\u3067\u306f\u3001Benefit-risk\u306e\u30d0\u30e9\u30f3\u30b9\u306f\u4e3b\u306b\u76f4\u611f\u7684\u306b\u8a55\u4fa1\u3055\u308c\u3066\u3044\u305f\u3068\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/report\/benefit-risk-methodology-project-work-package-4-report-benefit-risk-tools-processes_en.pdf\">Work package 4 report:<\/a> Benefit-risk tools and processes\u3092\u898b\u308b\u3068\u3001Benefit-risk\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u67a0\u7d44\u307f\u3068\u3057\u3066\u306f\u3001PrOACT-URL\u3001\u30e2\u30c7\u30eb\u3068\u3057\u3066\u306f\u3001<strong>Multi-criteria decision analysis (MCDA) models<\/strong>\uff08\u591a\u57fa\u6e96\u6c7a\u65ad\u5206\u6790\u30e2\u30c7\u30eb\uff09\u304c\u6700\u3082\u533b\u85ac\u54c1\u306e\u8a31\u8a8d\u53ef\u306e\u4f5c\u696d\u30d7\u30ed\u30bb\u30b9\u306b\u9069\u5408\u3059\u308b\u3053\u3068\u3001\u307e\u305f\u3001\u3053\u308c\u3089\u306e\u9069\u7528\u306f\u201d\u5224\u65ad\u304c\u96e3\u3057\u3044\u5834\u5408\u3001\u7570\u8ad6\u304c\u591a\u3044\u5834\u5408\u306b\u6709\u7528\u3067\u3042\u308d\u3046\u201d\u3068\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u5177\u4f53\u7684\u306b\u306f\u3001\u201d\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u306e\u30d0\u30e9\u30f3\u30b9\u304c\u8fd1\u63a5\u3057\u3066\u3044\u308b\u3001\u52b9\u679c\u306e\u81e8\u5e8a\u7684\u610f\u7fa9\u306e\u5224\u65ad\u306b\u3088\u308a\u671b\u307e\u3057\u3044\u3042\u308b\u3044\u306f\u671b\u307e\u3057\u304f\u306a\u3044\u306e\u3044\u305a\u308c\u306e\u65b9\u5411\u306b\u3082\u50be\u304d\u3046\u308b\u5834\u5408\u3001\u591a\u304f\u306e\u5c5e\u6027\u304c\u76f8\u53cd\u3059\u308b\u65b9\u5411\u3067\u3042\u308b\u5834\u5408\u201d\u304c\u4e0a\u3052\u3089\u308c\u3066\u3044\u307e\u3059\u3002PrOACT-URL\u306b\u3064\u3044\u3066\u306fPharmacoepidemiologic Reseach on Outcomes of Therapeutics by European Consortium <a href=\"http:\/\/protectbenefitrisk.eu\/index.html\">PROTECT<\/a>\u306e<a href=\"http:\/\/protectbenefitrisk.eu\/PrOACT-URL.html\">\u89e3\u8aac<\/a>\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002MCDA\u306b\u3064\u3044\u3066\u3082PROTECT\u306b<a href=\"http:\/\/protectbenefitrisk.eu\/MCDA.html\">\u89e3\u8aac<\/a>\u304c\u3042\u308a\u307e\u3059\u3002<br><\/p>\n\n\n\n<p><br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMA\u306fEuropean Medicines Agency \uff08\u6b27\u5dde\u533b\u85ac\u54c1\u5c40\uff09\u306e\u3053\u3068\u3067\u3001European Union (EU)\u6b27\u5dde\u9023\u5408\u306e\u533b\u85ac\u54c1\u898f\u5236\u5f53\u5c40\u3067\u3059\u3002EMA\u306f\u533b\u85ac\u54c1\u306e\u8a31\u8a8d\u53ef\u306e\u969b\u306bBenefits\u304cRisks\u3092\u4e0a\u56de\u308b\u304b &hellip; <a href=\"https:\/\/info.zanet.biz\/?p=342\" class=\"more-link\"><span class=\"screen-reader-text\">&#8220;EMA\u306eBenefit-risk methodology&#8221; \u306e<\/span>\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27,5,3],"tags":[],"class_list":["post-342","post","type-post","status-publish","format-standard","hentry","category-benefit-harm-assessment","category-cpg","category-mdm"],"_links":{"self":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/342","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=342"}],"version-history":[{"count":11,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/342\/revisions"}],"predecessor-version":[{"id":364,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/342\/revisions\/364"}],"wp:attachment":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=342"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=342"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=342"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}