{"id":1922,"date":"2025-12-23T14:21:25","date_gmt":"2025-12-23T06:21:25","guid":{"rendered":"https:\/\/www.vcro.com.tw\/cn\/?p=1922"},"modified":"2025-12-23T14:21:37","modified_gmt":"2025-12-23T06:21:37","slug":"fda%e5%8f%91%e5%b8%83%e8%8d%89%e6%a1%88%e6%8c%87%e5%bc%95%ef%bc%8c%e5%8e%98%e6%b8%85%e8%82%bf%e7%98%a4%e5%ad%a6%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e4%b8%ad%e6%95%b4%e4%bd%93%e5%ad%98%e6%b4%bb","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1922","title":{"rendered":"FDA\u53d1\u5e03\u8349\u6848\u6307\u5f15\uff0c\u5398\u6e05\u80bf\u7624\u5b66\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u6574\u4f53\u5b58\u6d3b\u671f\uff08Overall Survival, OS\uff09\u7684\u5e94\u7528 (Part I.)"},"content":{"rendered":"\n<p>\u6574\u4f53\u5b58\u6d3b\u671f\uff08OS\uff09\u88ab\u5b9a\u4e49\u4e3a\u81ea\u6cbb\u7597\u5f00\u59cb\u81f3\u4efb\u4f55\u539f\u56e0\u6b7b\u4ea1\u7684\u65f6\u95f4\uff0c\u88ab\u5e7f\u6cdb\u89c6\u4e3a\u80bf\u7624\u5b66\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u6700\u5177\u4e34\u5e8a\u610f\u4e49\u7684\u8bc4\u4f30\u6307\u6807\u3002\u5b83\u76f4\u63a5\u53cd\u6620\u4e86\u5927\u591a\u6570\u764c\u75c7\u6cbb\u7597\u7684\u4e3b\u8981\u76ee\u6807\uff1a\u5e2e\u52a9\u75c5\u4eba\u5ef6\u957f\u5bff\u547d\u3002\u7136\u800c\uff0c\u7531\u4e8e\u9700\u8981\u957f\u671f\u8ffd\u8e2a\u3001\u6cbb\u7597\u4ea4\u53c9\uff08crossover\uff09\u3001\u8bd5\u9a8c\u540e\u7684\u540e\u7eed\u6cbb\u7597\uff0c\u4ee5\u53ca\u75be\u75c5\u8fdb\u5c55\u540e\u7684\u6301\u7eed\u7528\u836f\u7b49\u56e0\u7d20\uff0cOS\u6570\u636e\u7684\u89e3\u8bfb\u5e38\u5177\u6311\u6218\u6027\u3002<\/p>\n\n\n\n<p>\u4e3a\u4e86\u89e3\u51b3\u8fd9\u4e9b\u590d\u6742\u95ee\u9898\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u4e8e2025\u5e748\u6708\u53d1\u5e03\u540d\u4e3a\u300a\u80bf\u7624\u5b66\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u6574\u4f53\u5b58\u6d3b\u671f\u8bc4\u4f30\u65b9\u6cd5\u300b\uff08Approaches to Assessment of Overall Survival in Oncology Clinical Trials\uff09\u7684\u8349\u6848\u6307\u5f15\u3002\u8be5\u6587\u4ef6\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u59d4\u6258\u8005\u63d0\u4f9b\u5efa\u8bae\uff0c\u8bf4\u660e\u5982\u4f55\u5728\u968f\u673a\u5bf9\u7167\u80bf\u7624\u5b66\u8bd5\u9a8c\u4e2d\u6070\u5f53\u5730\u89c4\u5212\u3001\u5206\u6790\u4e0e\u8be0\u91caOS\u8d44\u6599\uff0c\u4ee5\u652f\u6301\u836f\u54c1\u4e0a\u5e02\u6838\u51c6\uff0c\u7279\u522b\u662f\u5728OS\u5e76\u975e\u4e3b\u8981\u8bc4\u4f30\u6307\u6807\u7684\u60c5\u51b5\u4e0b\u3002<\/p>\n\n\n\n<p><strong><u>FDA<\/u><\/strong><strong><u>\u8349\u6848\u6307\u5f15\u7684\u4e3b\u8981\u5efa\u8bae<\/u><\/strong><strong><u><\/u><\/strong><\/p>\n\n\n\n<p><strong>1. OS<\/strong><strong>\u5206\u6790\u7684\u9884\u5148\u89c4\u5212\uff08<\/strong><strong>Prespecification of OS Analyses<\/strong><strong>\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u5f53OS\u5e76\u975e\u4e3b\u8981\u7597\u6548\u6307\u6807\u65f6\uff0cFDA\u5efa\u8bae\u5728\u4e34\u5e8a\u8bd5\u9a8c\u8ba1\u5212\u4e66\u53ca\u7edf\u8ba1\u5206\u6790\u8ba1\u5212\uff08SAP\uff09\u4e2d\uff0c<strong>\u9884\u5148\u5c06<\/strong><strong>OS<\/strong><strong>\u5217\u4e3a\u5b89\u5168\u6027\u6307\u6807<\/strong>\u3002\u5982\u6b64\u53ef\u786e\u4fdd\u5373\u4f7f\u8bd5\u9a8c\u4e3b\u8981\u900f\u8fc7\u66ff\u4ee3\u6307\u6807\uff08surrogate endpoints\uff09\u8bc1\u660e\u7597\u6548\uff0c\u4e5f\u80fd\u5145\u5206\u8bc4\u4f30\u56e0\u6cbb\u7597\u6bd2\u6027\u6216\u76f8\u5173\u5e76\u53d1\u75c7\u5bfc\u81f4\u7684\u5b58\u6d3b\u671f\u4e0b\u964d\u7b49\u6f5c\u5728\u98ce\u9669\u3002<\/p>\n\n\n\n<p><strong>2. <\/strong><strong>\u671f\u4e2d\u5206\u6790\u4e0e\u5b89\u5168\u76d1\u6d4b\uff08<\/strong><strong>Interim Analyses and Safety Monitoring<\/strong><strong>\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u5bf9\u4e8e\u5927\u578b\u968f\u673a\u8bd5\u9a8c\uff0cFDA\u9f13\u52b1\u7eb3\u5165<strong>\u671f\u4e2d\u5206\u6790<\/strong>\uff0c\u4ee5\u8bc4\u4f30\u8bd5\u9a8c\u662f\u5426\u5b58\u5728\u7597\u6548\u65e0\u76ca\uff08futility\uff09\u6216\u65b0\u51fa\u73b0\u7684\u5b89\u5168\u7591\u8651\u3002\u8fd9\u4e9b\u5206\u6790\u5e94\u7531<strong>\u72ec\u7acb\u6570\u636e\u76d1\u6d4b\u59d4\u5458\u4f1a\uff08<\/strong><strong>Independent Data Monitoring Committee<\/strong><strong>\uff09<\/strong>\u5ba1\u67e5\uff0c\u4ee5\u786e\u4fdd\u53d7\u8bd5\u8005\u5b89\u5168\uff0c\u5e76\u907f\u514d\u53d7\u8bd5\u8005\u66b4\u9732\u4e8e\u65e0\u6548\u6216\u6709\u5bb3\u7684\u6cbb\u7597\u4e2d\u3002<\/p>\n\n\n\n<p><strong>3. <\/strong><strong>\u6cbb\u7597\u610f\u5411\u5206\u6790\uff08<\/strong><strong>Intention-to-Treat, ITT Analysis<\/strong><strong>\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u4e3b\u8981\u7684OS\u5206\u6790\u5e94\u91c7\u7528<strong>\u6cbb\u7597\u610f\u5411\u539f\u5219\uff08<\/strong><strong>ITT<\/strong><strong>\uff09<\/strong>\uff0c\u5373\u6240\u6709\u968f\u673a\u5206\u6d3e\u7684\u53d7\u8bd5\u8005\u7686\u4f9d\u7167\u5176\u539f\u59cb\u5206\u7ec4\u8fdb\u884c\u5206\u6790\u3002\u6b64\u4f5c\u6cd5\u6709\u52a9\u4e8e\u7ef4\u6301\u968f\u673a\u5316\u8bbe\u8ba1\u7684\u5b8c\u6574\u6027\uff0c\u5e76\u964d\u4f4e\u5206\u6790\u504f\u5dee\u3002<\/p>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1536\" data-id=\"1923\" src=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/12\/ChatGPT-Image-Dec-23-2025-01_44_24-PM.png\" alt=\"\" class=\"wp-image-1923\"\/><\/figure>\n<\/figure>\n","protected":false},"excerpt":{"rendered":"<p>\u6574\u4f53\u5b58\u6d3b\u671f\uff08OS\uff09\u88ab\u5b9a\u4e49\u4e3a\u81ea\u6cbb\u7597\u5f00\u59cb\u81f3\u4efb\u4f55\u539f\u56e0\u6b7b\u4ea1\u7684\u65f6\u95f4\uff0c\u88ab\u5e7f\u6cdb\u89c6\u4e3a\u80bf\u7624\u5b66\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u6700\u5177\u4e34\u5e8a\u610f\u4e49\u7684\u8bc4\u4f30\u6307\u6807\u3002\u5b83 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1923,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[181,145,185,186,182,183,184],"class_list":["post-1922","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11","tag-181","tag-145","tag-185","tag-186","tag-182","tag-183","tag-184"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - 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