{"id":1864,"date":"2025-09-02T20:23:43","date_gmt":"2025-09-02T11:23:43","guid":{"rendered":"https:\/\/info.zanet.biz\/?p=1864"},"modified":"2025-09-02T20:23:44","modified_gmt":"2025-09-02T11:23:44","slug":"fda%e3%81%aestructured-benefit-risk-framework%e3%81%a8patients-preference-information-ppi","status":"publish","type":"post","link":"https:\/\/info.zanet.biz\/?p=1864","title":{"rendered":"FDA\u306eStructured Benefit-Risk Framework\u3068Patient&#8217;s preference information (PPI)"},"content":{"rendered":"\n<p>FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306e\u533b\u7642\u6a5f\u5668\u30fb\u653e\u5c04\u7dda\u4fdd\u5065\u30bb\u30f3\u30bf\u30fc\uff08CDRH\uff09\u3068\u533b\u7642\u6a5f\u5668\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30bd\u30fc\u30b7\u30a2\u30e0\uff08MDIC\uff09\u304c\u5171\u540c\u3067\u958b\u767a\u3057\u305fMDIC\u60a3\u8005\u4e2d\u5fc3\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\uff08PCBR\uff09\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u3064\u3044\u3066\u3001\u4ee5\u524d\u7d39\u4ecb\u3057\u307e\u3057\u305f(<a href=\"\/index.php?p=351\" target=\"_blank\" rel=\"noreferrer noopener\">351<\/a>, <a href=\"\/index.php?p=436\" target=\"_blank\" rel=\"noreferrer noopener\">436<\/a>)\u3002<\/p>\n\n\n\n<p>\u5f53\u5c40\u306e\u8a31\u8a8d\u53ef\u3092\u76ee\u7684\u3068\u3059\u308b\u6cbb\u9a13\u3067\u3001Patient&#8217;s preference information\uff08PPI, \u60a3\u8005\u306e\u9078\u597d\u306b\u95a2\u3059\u308b\u60c5\u5831\uff09\u3092\u8abf\u67fb\u3001\u8a18\u9332\u3059\u308b\u3053\u3068\u304c\u91cd\u8996\u3055\u308c\u3066\u304a\u308a\u3001\u7533\u8acb\u6642\u306bStructured Benefit Risk Framework\u3092\u7528\u3044\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u3088\u3046\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u4eca\u56de\u3001\u3053\u308c\u3089\u306b\u3064\u3044\u3066\u307e\u3068\u3081\u3066\u30012\u3064\u306ePDF\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3057\u307e\u3057\u305f\u3002\u4f5c\u6210\u306b\u306fGoogle <a href=\"https:\/\/notebooklm.google.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">NotebookLM<\/a>\u3068<a href=\"https:\/\/gamma.app\/ja\" target=\"_blank\" rel=\"noreferrer noopener\">gamma<\/a>\u3092\u4f7f\u3044\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u30fbFDA\u306eStructured Benefit-Risk Framework: \u533b\u85ac\u54c1\u8a55\u4fa1\u306b\u304a\u3051\u308b\u900f\u660e\u6027\u3068\u4e00\u8cab\u6027\u306e\u78ba\u4fdd <a href=\"https:\/\/info.zanet.biz\/dl\/FDAStructured-Benefit-Risk-Framework.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">PDF<\/a><\/p>\n\n\n\n<p>\u30fbFDA\u306eStructured Benefit-Risk Framework\u3068\u60a3\u8005\u9078\u597d\u60c5\u5831 (PPI) <a href=\"https:\/\/info.zanet.biz\/dl\/FDAStructured-Benefit-Risk-FrameworkPPI.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">PDF<\/a><\/p>\n\n\n\n<p>\u7528\u8a9e\u3092\u78ba\u8a8d\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\uff1a<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-1024x576.png\" alt=\"\" class=\"wp-image-1865\" srcset=\"https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-1024x576.png 1024w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-300x169.png 300w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-768x432.png 768w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-1536x864.png 1536w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-1200x675.png 1200w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image.png 1600w\" sizes=\"auto, (max-width: 709px) 85vw, (max-width: 909px) 67vw, (max-width: 1362px) 62vw, 840px\" \/><\/figure>\n\n\n\n<p>Importance of outcome \u30a2\u30a6\u30c8\u30ab\u30e0\u306e\u91cd\u8981\u6027\/\u91cd\u8981\u5ea6\u3001Values\u4fa1\u5024\u89b3\u3001Preferences\u9078\u597d\u306e\u95a2\u4fc2\u306f\u4ee5\u4e0b\u306e\u69d8\u306b\u8868\u73fe\u3055\u308c\u308b\u3068\u601d\u3044\u307e\u3059\u3002GRADE Working Group\u306f\u30a2\u30a6\u30c8\u30ab\u30e0\u306e\u91cd\u8981\u5ea6\u3068\u60a3\u8005\u306e\u4fa1\u5024\u89b3\u306f\u540c\u3058\u3053\u3068\u3092\u610f\u5473\u3057\u3066\u304a\u308a\u3001\u6587\u8108\u306b\u3088\u308a\u4f7f\u3044\u5206\u3051\u308b\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-2-1024x576.png\" alt=\"\" class=\"wp-image-1867\" style=\"width:513px;height:auto\" srcset=\"https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-2-1024x576.png 1024w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-2-300x169.png 300w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-2-768x432.png 768w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-2-1536x864.png 1536w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-2-1200x675.png 1200w, https:\/\/info.zanet.biz\/wp\/wp-content\/uploads\/2025\/09\/image-2.png 1600w\" sizes=\"auto, (max-width: 709px) 85vw, (max-width: 909px) 67vw, (max-width: 1362px) 62vw, 840px\" \/><\/figure>\n\n\n\n<p>\u6587\u732e\uff1a<br>Ho M, Saha A, McCleary KK, Levitan B, Christopher S, Zandlo K, Braithwaite RS, Hauber AB: A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies. Value Health. 2016;19:746-750. doi: 10.1016\/j.jval.2016.02.019 doi: 10.1016\/j.jval.2016.02.019 PMID: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/27712701\/\" target=\"_blank\" rel=\"noreferrer noopener\">27712701<\/a><\/p>\n\n\n\n<p>\u2022Boyd CM, Singh S, Varadhan R, Weiss CO, Sharma R, Bass EB, Puhan MA. Methods for Benefit and Harm Assessment in Systematic Reviews. Methods Research Report. (Prepared by the Johns Hopkins University Evidence-based Practice Center under contract No. 290-2007-10061-I). AHRQ Publication No. 12(13)-EHC150-EF. Rockville, MD: Agency for Healthcare Research and Quality; November 2012. <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK115754\/\" target=\"_blank\" rel=\"noreferrer noopener\">Link<\/a><\/p>\n\n\n\n<p>Alper BS, Oettgen P, Kunnamo I, Iorio A, Ansari MT, Murad MH, Meerpohl JJ, Qaseem A, Hultcrantz M, Sch\u00fcnemann HJ, Guyatt G, GRADE Working Group: Defining certainty of net benefit: a GRADE concept paper. BMJ Open 2019;9:e027445. PMID: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/31167868\/\" target=\"_blank\" rel=\"noreferrer noopener\">31167868<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306e\u533b\u7642\u6a5f\u5668\u30fb\u653e\u5c04\u7dda\u4fdd\u5065\u30bb\u30f3\u30bf\u30fc\uff08CDRH\uff09\u3068\u533b\u7642\u6a5f\u5668\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30bd\u30fc\u30b7\u30a2\u30e0\uff08MDIC\uff09\u304c\u5171\u540c\u3067\u958b\u767a\u3057\u305fMDIC\u60a3\u8005\u4e2d\u5fc3\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\uff08PCBR\uff09\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u3064\u3044\u3066\u3001\u4ee5\u524d\u7d39\u4ecb\u3057\u307e\u3057 &hellip; <a href=\"https:\/\/info.zanet.biz\/?p=1864\" class=\"more-link\"><span class=\"screen-reader-text\">&#8220;FDA\u306eStructured Benefit-Risk Framework\u3068Patient&#8217;s preference information (PPI)&#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":[27,3],"tags":[],"class_list":["post-1864","post","type-post","status-publish","format-standard","hentry","category-benefit-harm-assessment","category-mdm"],"_links":{"self":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/1864","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=1864"}],"version-history":[{"count":6,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/1864\/revisions"}],"predecessor-version":[{"id":1873,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/1864\/revisions\/1873"}],"wp:attachment":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1864"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1864"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}