{"id":2080,"date":"2026-02-23T21:02:35","date_gmt":"2026-02-23T13:02:35","guid":{"rendered":"https:\/\/www.vcro.com.tw\/tw\/?p=2080"},"modified":"2026-02-23T21:02:47","modified_gmt":"2026-02-23T13:02:47","slug":"fda%e7%99%bc%e5%b8%83%e8%8d%89%e6%a1%88%e6%8c%87%e5%bc%95%ef%bc%8c%e9%87%90%e6%b8%85%e8%85%ab%e7%98%a4%e5%ad%b8%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a9%97%e4%b8%ad%e6%95%b4%e9%ab%94%e5%ad%98%e6%b4%bb-2","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=2080","title":{"rendered":"FDA\u767c\u5e03\u8349\u6848\u6307\u5f15\uff0c\u91d0\u6e05\u816b\u7624\u5b78\u81e8\u5e8a\u8a66\u9a57\u4e2d\u6574\u9ad4\u5b58\u6d3b\u671f\uff08Overall Survival, OS\uff09\u7684\u61c9\u7528 (Part II.)"},"content":{"rendered":"\n<p><strong>4. <\/strong><strong>\u5e72\u64fe\u4e8b\u4ef6\u7684\u8655\u7406\uff08<\/strong><strong>Managing Intercurrent Events<\/strong><strong>\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u8a66\u9a57\u8a2d\u8a08\u968e\u6bb5\u61c9\u4e8b\u5148\u898f\u5283\u5982\u4f55\u8655\u7406<strong>\u5e72\u64fe\u4e8b\u4ef6\uff08<\/strong><strong>intercurrent events<\/strong><strong>\uff09<\/strong>\uff0c\u4f8b\u5982\u6cbb\u7642\u4ea4\u53c9\u3001\u5f8c\u7e8c\u6cbb\u7642\u6216\u63d0\u65e9\u505c\u85e5\u7b49\u60c5\u5f62\u3002\u9019\u4e9b\u4e8b\u4ef6\u61c9\u5728\u7d71\u8a08\u5206\u6790\u4e2d\u52a0\u4ee5\u63a7\u5236\u8207\u89e3\u91cb\uff0c\u4ee5\u78ba\u4fddOS\u7d50\u679c\u80fd\u771f\u5be6\u53cd\u6620\u6cbb\u7642\u6548\u679c\u3002<\/p>\n\n\n\n<p><strong>5. <\/strong><strong>\u654f\u611f<\/strong><strong>\u5ea6<\/strong><strong>\u8207\u6b21\u7fa4<\/strong><strong>\u7d44<\/strong><strong>\u5206\u6790\uff08<\/strong><strong>Sensitivity and Subgroup Analyses<\/strong><strong>\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u70ba\u9a57\u8b49OS\u7d50\u679c\u7684\u8010\u8b8a\u6027\uff0c\u6307\u5f15\u5efa\u8b70\u9032\u884c<strong>\u654f\u611f\u5ea6\u5206\u6790<\/strong>\u8207<strong>\u6b21\u7fa4\u7d44\u5206\u6790<\/strong>\u3002\u9019\u4e9b\u5206\u6790\u6709\u52a9\u65bc\u78ba\u8a8dOS\u7d50\u679c\u5728\u4e0d\u540c\u75c5\u4eba\u65cf\u7fa4\u4e2d\u662f\u5426\u4e00\u81f4\uff0c\u6216\u5728\u4e0d\u540c\u5047\u8a2d\uff08\u4f8b\u5982\u6392\u9664\u8f49\u63db\u6cbb\u7642\u8005\uff09\u4e0b\u662f\u5426\u4ecd\u5177\u7a69\u5b9a\u6027\u3002\u5177\u6709\u751f\u7269\u5b78\u6216\u81e8\u5e8a\u5408\u7406\u6027\u7684\u6b21\u7fa4\u7d44\u61c9\u65bcSAP\u4e2d\u4e8b\u5148\u660e\u78ba\u5b9a\u7fa9\u3002<\/p>\n\n\n\n<p><strong>6. <\/strong><strong>\u6392\u9664\u5b58\u6d3b\u4e0d\u826f\u5f71\u97ff\uff08<\/strong><strong>Ruling Out Harm<\/strong><strong>\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u82e5\u8a66\u9a57\u4ee5\u975eOS\u6307\u6a19\u4f5c\u70ba\u4e3b\u8981\u7642\u6548\u4f9d\u64da\uff0cFDA\u5efa\u8b70\u8a2d\u5b9a\u660e\u78ba\u7684\u300c<strong>\u6392\u9664\u5b58\u6d3b\u4e0d\u826f\u5f71\u97ff<\/strong>\u300d\u7d71\u8a08\u95be\u503c\u3002\u9019\u4e9b\u95be\u503c\u61c9\u4f9d\u64da\u75be\u75c5\u7279\u6027\u3001\u9810\u671f\u6cbb\u7642\u6548\u679c\u3001\u8a66\u9a57\u671f\u9593\u53ca\u6f5b\u5728\u6cbb\u7642\u98a8\u96aa\u9032\u884c\u79d1\u5b78\u5408\u7406\u5316\uff0c\u85c9\u4ee5\u78ba\u8a8d\u6cbb\u7642\u672a\u5c0e\u81f4\u6574\u9ad4\u5b58\u6d3b\u671f\u4e0b\u964d\u3002<\/p>\n\n\n\n<p><strong>7. <\/strong><strong>\u9650\u5236\u4e8b\u5f8c\u5206\u6790\uff08<\/strong><strong>Limitations of Post Hoc Analyses<\/strong><strong>\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u6307\u5f15\u5f37\u8abf\uff0c\u51e1\u672a\u65bcSAP\u4e2d\u9810\u5148\u898f\u5283\u7684<strong>\u4e8b\u5f8c\u6b21\u7fa4\u7d44\u5206\u6790<\/strong>\u61c9\u50c5\u8996\u70ba\u63a2\u7d22\u6027\u5206\u6790\uff08exploratory\uff09\u3002\u96d6\u7136\u6b64\u985e\u7d50\u679c\u53ef\u4f5c\u70ba\u5f8c\u7e8c\u7814\u7a76\u5047\u8a2d\u7684\u4f9d\u64da\uff0c\u4f46\u7531\u65bc\u5b58\u5728\u504f\u5dee\u98a8\u96aa\uff0c\u4e26\u4e0d\u9069\u5408\u4f5c\u70ba\u5224\u5b9a\u6cbb\u7642\u6548\u679c\u7684\u78ba\u5207\u4f9d\u64da\u3002<\/p>\n\n\n\n<p><strong>\u7e3d\u7d50<\/strong><strong><\/strong> FDA\u7684\u8349\u6848\u6307\u5f15\u63d0\u4f9b\u4e86\u4e00\u5957\u5b8c\u6574\u7684\u6846\u67b6\uff0c\u5354\u52a9\u81e8\u5e8a\u8a66\u9a57\u5718\u968a\u5728\u816b\u7624\u5b78\u7814\u7a76\u4e2d\u66f4\u56b4\u8b39\u5730\u898f\u5283\u3001\u5206\u6790\u8207\u8a6e\u91cb\u6574\u9ad4\u5b58\u6d3b\u671f\u8cc7\u6599\u3002\u6587\u4ef6\u5f37\u8abf\u56b4\u5bc6\u7684\u7814\u7a76\u8a2d\u8a08\u8207\u9810\u5148\u5b9a\u7fa9\u7684\u7d71\u8a08\u7b56\u7565\uff0c\u662f\u78ba\u4fddOS\u7d50\u679c\u5177\u5099\u53ef\u9760\u6027\u3001\u81e8\u5e8a\u610f\u7fa9\u4e26\u53ef\u652f\u6301\u76e3\u7ba1\u6c7a\u7b56\u7684\u95dc\u9375\u3002\u900f\u904e\u91dd\u5c0d\u73fe\u4ee3\u764c\u75c7\u8a66\u9a57\u4e2d\u5e38\u898b\u8907\u96dc\u60c5\u5883\u7684\u6307\u5c0e\uff0c\u8a72\u8349\u6848\u6709\u52a9\u65bc\u78ba\u4fdd\u5b58\u6d3b\u671f\u4ecd\u80fd\u4f5c\u70ba\u8a55\u4f30\u764c\u75c7\u6cbb\u7642\u6548\u76ca\u8207\u98a8\u96aa\u7684\u91cd\u8981\u6838\u5fc3\u6307\u6a19\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1536\" src=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/12\/ChatGPT-Image-Dec-23-2025-01_44_24-PM.png\" alt=\"\" class=\"wp-image-2076\"\/><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>4. \u5e72\u64fe\u4e8b\u4ef6\u7684\u8655\u7406\uff08Managing Intercurrent Events\uff09 \u8a66\u9a57\u8a2d\u8a08\u968e\u6bb5\u61c9\u4e8b\u5148\u898f\u5283\u5982\u4f55\u8655 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[212,211,213,207,210,204,214],"class_list":["post-2080","post","type-post","status-publish","format-standard","hentry","category-11","tag-212","tag-211","tag-213","tag-207","tag-210","tag-204","tag-214"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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