{"id":436,"date":"2019-05-12T21:00:58","date_gmt":"2019-05-12T12:00:58","guid":{"rendered":"https:\/\/info.zanet.biz\/?p=436"},"modified":"2019-06-24T16:10:41","modified_gmt":"2019-06-24T07:10:41","slug":"fda%e3%81%aebenefit-risk-assessment%ef%bc%88%e7%b6%9a%e3%81%8d%ef%bc%89","status":"publish","type":"post","link":"https:\/\/info.zanet.biz\/?p=436","title":{"rendered":"FDA\u306eBenefit-Risk Assessment\uff08\u7d9a\u304d\uff09"},"content":{"rendered":"\n

The Food and Drug Administration Safety and Innovation Act\u304c2012\u5e74<\/strong>\u306b\u767a\u52b9\u3057\u3001\u305d\u306e Section 905\u306fFDA<\/a>\u306eCenter for Drug Evaluation and Research (CDER<\/a>) \u306b\u5bfe\u3057\u3066\u65b0\u85ac\u306e\u627f\u8a8d\u306b\u3042\u305f\u308a\u3001\u69cb\u9020\u5316\u3055\u308c\u305fbenefit-risk assessment framework\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3092\u6c42\u3081\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3057\u305f\u3002 2018\u5e74CDER\u306f\u3001Benefit-Risk Assessment in Drug Regulatory Decision-Making. Draft PDUFA VI Implementation Plan (FY 2018-2022)\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u3061\u3089\u304b\u3089\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/a>\u3067\u304d\u307e\u3059\u3002 <\/p>\n\n\n\n

\u3055\u3089\u306b\u3001\u540c\u3058\u304f2012\u5e74\u306b, FDA\u306eCenter for Devices and Radiological Health (CDRH<\/a>) \u306fGuidance to clarify the principal benefit-risk assessment\u3068\u3044\u3046\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868\u3057\u3001\u201cpatient tolerance for risk and perspective on benefit\u201d\u3059\u306a\u308f\u3061\u300c\u60a3\u8005\u306e\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u8a31\u5bb9\u5ea6\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306b\u5bfe\u3059\u308b\u8996\u70b9\u3092\u627f\u8a8d\u306e\u30ec\u30d3\u30e5\u30fc\u306e\u969b\u306b\u8ffd\u52a0\u306e\u30d5\u30a1\u30af\u30bf\u30fc\u3068\u3057\u3066\u8003\u616e\u3059\u308b\u3053\u3068\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u5f8c\u3001CDRH\u306f2013\u5e74Patient Preference Initiative\u3068\u3044\u3046\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u958b\u59cb\u3057\u3001Medical Device Advisory Committee (MDAC) \u306b\u60a3\u8005\u306e\u30d1\u30cd\u30eb\u306e\u53c2\u52a0\u306b\u3064\u3044\u3066\u65b9\u91dd\u3092\u5b9a\u3081\u305f\u305d\u3046\u3067\u3059\u3002 CDRH\u306eMedical Device Innovation Consortium MDIC<\/a>\u306f\u3001The MDIC Patient Centered Benefit-Risk (PCBR) Project\u30922013\u5e74\u306b\u958b\u59cb\u3057\u3001MEDICAL DEVICE INNOVATION CONSORTIUM (MDIC) PATIENT CENTERED  BENEFIT-RISK PROJECT REPORT: A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology\u3068\u3044\u3046\u5831\u544a\u66f8\u30922015\u5e74\u306b\u767a\u884c\u3057\u307e\u3057\u305f\u3002\u3053\u3061\u3089\u304b\u3089\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/a>\u304c\u3067\u304d\u307e\u3059\u304c\u767b\u9332\u304c\u5fc5\u8981\u3002
<\/p>\n\n\n\n

CDRH Patient Engagement<\/a>\u3082\u898b\u3066\u304f\u3060\u3055\u3044\u3002\u3044\u308d\u3044\u308d\u306a\u8cc7\u6599\u304c\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002Patient and Public Involvement\u3082\u91cd\u8981\u306a\u8ab2\u984c\u3067\u3059\u3002 <\/p>\n\n\n\n

\u8ad6\u6587\u3068\u3057\u3066\u306f\u3001
Johnson FR, Zhou M: Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective. Value Health 2016;19:741-745. PMID: 27712700<\/a>\u304c\u767a\u8868\u3055\u308c\u3066\u3044\u307e\u3059\u3002 Role of Patient Preferences\u60a3\u8005\u306e\u9078\u597d\u306e\u5f79\u5272\u306b\u3064\u3044\u3066\u306f\u3001”Weighing benefits and risks of new health technologies requires not only assessing the available scientific evidence but also making societal value judgments about the relative importance of benefits and risks measured in different, noncomparable units.” \u3068\u8a18\u8ff0\u3055\u308c\u3066\u304a\u308a\u3001\u5358\u306a\u308b\u52b9\u679c\u63a8\u5b9a\u5024\u306e\u5024\u3001\u3059\u306a\u308f\u3061\u52b9\u679c\u306e\u5927\u304d\u3055\u3068\u4e0d\u78ba\u5b9f\u6027\u3060\u3051\u3067\u306a\u304f\u3001\u4fa1\u5024\u89b3\u306b\u57fa\u3065\u304f\u3001\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3068\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u304c\u5fc5\u8981\u306a\u3053\u3068\u304c\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6587\u7ae0\u3092\u8aad\u3080\u3060\u3051\u3067\u3001\u2460\u30e9\u30f3\u30c0\u30e0\u5316\u6bd4\u8f03\u8a66\u9a13\u306a\u3069\u3067\u5f97\u3089\u308c\u305f\u79d1\u5b66\u7684\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u8a55\u4fa1\u3060\u3051\u3067\u306f\u3001\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3068\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u306f\u3067\u304d\u306a\u3044\u3001\u2461\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3068\u30ea\u30b9\u30af\u306e\u76f8\u5bfe\u7684\u306a\u91cd\u8981\u6027\u306b\u95a2\u3059\u308b\u793e\u4f1a\u7684\u306a\u4fa1\u5024\u5224\u65ad\u304c\u5fc5\u8981\u3001\u2462\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3068\u30ea\u30b9\u30af\u306f\u6bd4\u8f03\u304c\u3067\u304d\u306a\u3044\u7570\u306a\u308b\u5c3a\u5ea6\u3067\u6e2c\u5b9a\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u3001\u3068\u3044\u3046\u3053\u3068\u304c\u5206\u304b\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\u3055\u3089\u306b\u3001
Ho M, Saha A, McCleary KK, Levitan B, Christopher S, Zandlo K, Braithwaite RS, Hauber AB, Medical Device Innovation Consortium\u2019s Patient Centered Benefit-Risk Steering Committee: A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies. Value Health 2016;19:746-750. PMID: 27712701<\/a> \u306b\u306f\u5177\u4f53\u7684\u306a\u624b\u6cd5\u306b\u3064\u3044\u3066\u8a18\u8ff0\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u8ad6\u6587\u306e\u4e2d\u306bMDIC’s Preference Assessment Methodology Catalog\u304c\u3042\u308a\u3001Table 2-List of methods included in the Catalog \u306b\u306f\u3001Prefrence\u9078\u597d\u306e\u8a55\u4fa1\u6cd5\u306b\u95a2\u3057\u3066\u3055\u307e\u3056\u307e\u306a\u65b9\u6cd5\u304c\u307e\u3068\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

\u88682-\u30ab\u30bf\u30ed\u30b0\u306b\u542b\u307e\u308c\u308b\u65b9\u6cd5\u306e\u30ea\u30b9\u30c8<\/p>\n\n\n\n
\u30b0\u30eb\u30fc\u30d7 <\/td>\u65b9\u6cd5<\/td><\/tr>
Structured weighting
\u69cb\u9020\u5316\u3055\u308c\u305f\u91cd\u307f\u3065\u3051<\/td>		Simple direct weighting \u5358\u7d14\u76f4\u63a5\u91cd\u307f\u3065\u3051
Ranking excercises \u30e9\u30f3\u30ad\u30f3\u30b0\u30a8\u30af\u30b5\u30b5\u30a4\u30ba
Swing weighting \u30b9\u30a6\u30a3\u30f3\u30b0\u30a6\u30a7\u30a4\u30c6\u30a3\u30f3\u30b0
Point allocation \u30dd\u30a4\u30f3\u30c8\u914d\u7f6e
Analytic hierarchy process \u5206\u6790\u7684\u968e\u5c64\u6cd5
Outranking methods \u30a2\u30a6\u30c8\u30e9\u30f3\u30ad\u30f3\u30b0\u6cd5<\/td><\/tr>
Health-state utility\u5065\u5eb7\u72b6\u614b\u52b9\u7528<\/td>Time trade-off \u6642\u9593\u5f97\u5931\u6cd5
Standard gamble \u6a19\u6e96\u8ced\u3051\u6cd5<\/td><\/tr>
Stated preference\u8868\u660e\u9078\u597d<\/td>Direct-assessment questions \u76f4\u63a5\u8a55\u4fa1\u8cea\u554f
Threshold technique \u95be\u5024\u30c6\u30af\u30cb\u30c3\u30af
Conjoint analysis and discrete-choice experiments \u30b3\u30f3\u30b8\u30e7\u30a4\u30f3\u30c8\u5206\u6790\u304a\u3088\u3073\u96e2\u6563\u9078\u629e\u5206\u6790
Best-worst scaling exercises \u6700\u5584\u6700\u60aa\u30b9\u30b1\u30fc\u30ea\u30f3\u30b0\u30a8\u30af\u30b5\u30b5\u30a4\u30ba<\/td><\/tr>
Revealed preference
\u9855\u793a\u9078\u597d<\/td>		Patient preference trials \u60a3\u8005\u9078\u597d\u8a66\u9a13
Direct questions in clinical trials \u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u76f4\u63a5\u8cea\u554f<\/td><\/tr><\/tbody><\/table>\n\n\n\n

FDA\u3082EMA\u3082\u307b\u3068\u3093\u3069\u540c\u3058\u8003\u3048\u65b9\u3067\u5b9a\u91cf\u7684\u306a\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3068\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u6cd5Quantitative Benefit-Risk Assessment\u3092\u6a21\u7d22\u3057\u3066\u304d\u305f\u3053\u3068\u304c\u5206\u304b\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\u8a3a\u7642\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u4f5c\u6210\u6642\u306b\u76ca\u3068\u5bb3\u306e\u8a55\u4fa1\u3092\u3069\u306e\u3088\u3046\u306b\u884c\u3046\u304b\u306f\u91cd\u8981\u306a\u30c6\u30fc\u30de\u3067\u3059\u304c\u3001\u201d\u52b9\u679c\u63a8\u5b9a\u5024\u306e\u5927\u304d\u3055\u3068\u4e0d\u78ba\u5b9f\u6027\u201d\u3068\u201d\u76ca\u3068\u5bb3\u306e\u5927\u304d\u3055\u3068\u30d0\u30e9\u30f3\u30b9\u306e\u4e0d\u78ba\u5b9f\u6027\u307e\u305f\u306f\u6b63\u5473\u306e\u76ca\u306e\u4e0d\u78ba\u5b9f\u6027\u201d\u306f\u540c\u3058\u3067\u306f\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3092\u8a8d\u8b58\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u76ca\u3068\u5bb3\u306e\u8a55\u4fa1\u306b\u306f\u4fa1\u5024\u89b3\u304c\u95a2\u4fc2\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u3053\u308c\u306fComparative Effectiveness Research (CER)\u306e\u7406\u89e3\u3068\u3082\u95a2\u4fc2\u3057\u307e\u3059\u3002\u306a\u304a\u3001\u30ea\u30b9\u30afRisk\u306f\u5bb3Harm\u3068\u540c\u3058\u610f\u5473\u3067\u7528\u3044\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001Preference\u3068Value\u3082\u540c\u3058\u610f\u5473\u3067\u7528\u3044\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

\u524d\u306e\u6295\u7a3fFDA\u306eBenefit-Risk Assessment Framework\u306f\u3053\u3061\u3089<\/a>\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

The Food and Drug Administration Safety and Innovation Act\u304c2012\u5e74\u306b\u767a\u52b9\u3057\u3001\u305d\u306e Section 905\u306fFDA\u306eCenter for Drug Evalua … “FDA\u306eBenefit-Risk Assessment\uff08\u7d9a\u304d\uff09” \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":[27,3,6],"tags":[],"class_list":["post-436","post","type-post","status-publish","format-standard","hentry","category-benefit-harm-assessment","category-mdm","category-sdm"],"_links":{"self":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/436","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=436"}],"version-history":[{"count":10,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/436\/revisions"}],"predecessor-version":[{"id":546,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/436\/revisions\/546"}],"wp:attachment":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}