{"id":1704,"date":"2026-03-06T15:44:59","date_gmt":"2026-03-06T07:44:59","guid":{"rendered":"https:\/\/www.millibuff.com\/?p=1704"},"modified":"2026-03-06T15:44:59","modified_gmt":"2026-03-06T07:44:59","slug":"%e5%b0%8f%e7%89%9b%e8%a7%82%e5%af%9f-%e5%8d%95%e9%a1%b9%e8%af%95%e9%aa%8c%e5%ae%9a%e7%94%9f%e6%ad%bb%ef%bc%9a%e4%b8%ad%e5%9b%bd%e5%88%9b%e6%96%b0%e8%8d%af%e4%b8%b4%e5%ba%8a%e5%bc%80%e5%8f%91","status":"publish","type":"post","link":"https:\/\/www.millibuff.com\/?p=1704","title":{"rendered":"\u5c0f\u725b\u89c2\u5bdf | 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class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"436\" src=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/03\/\u7a3f\u5b9a\u8bbe\u8ba1-1-1024x436.jpg\" alt=\"\" class=\"wp-image-1706\" srcset=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/03\/\u7a3f\u5b9a\u8bbe\u8ba1-1-1024x436.jpg 1024w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/03\/\u7a3f\u5b9a\u8bbe\u8ba1-1-300x128.jpg 300w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/03\/\u7a3f\u5b9a\u8bbe\u8ba1-1-768x327.jpg 768w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/03\/\u7a3f\u5b9a\u8bbe\u8ba1-1-1536x654.jpg 1536w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/03\/\u7a3f\u5b9a\u8bbe\u8ba1-1.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">PART 01<br>\u56fd\u5185\u76d1\u7ba1\u903b\u8f91\u7684\u201c\u540c\u201d\u4e0e\u201c\u4e0d\u540c\u201d<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. \u5355\u81c2\u8bd5\u9a8c\uff1a<\/strong><strong>\u56fd\u5185<\/strong><strong>\u5df2\u6709\u201c\u7a81\u7834\u6027\u8def\u5f84\u201d<\/strong><strong><\/strong><\/h3>\n\n\n\n<p>FDA\u65b0\u653f\u7684\u6838\u5fc3\u662f\u5c06\u201c\u5355\u9879\u5173\u952e\u8bd5\u9a8c\u201d\uff08\u4e00\u9879\u5145\u5206\u4e14\u6709\u826f\u597d\u5bf9\u7167\u7684\u4e34\u5e8a\u7814\u7a76+\u786e\u8bc1\u6027\u8bc1\u636e\uff09\u4f5c\u4e3a\u9ed8\u8ba4\u6807\u51c6\u3002\u800c\u5728\u56fd\u5185\uff0c\u76d1\u7ba1\u5c42\u9762\u540c\u6837\u5c55\u73b0\u51fa\u4f18\u5316\u8bd5\u9a8c\u6570\u91cf\u7684\u7075\u6d3b\u6027\uff0c\u4f8b\u5982\u5728\u6297\u80bf\u7624\u836f\u7269\u9886\u57df\u5bf9\u65e0\u5bf9\u7167\u7684\u201c\u5355\u81c2\u8bd5\u9a8c\u201d\u7684\u63a2\u7d22\u5df2\u5b9e\u8df5\u591a\u5e74\u3002<\/p>\n\n\n\n<p><strong>\u672f\u8bed\u6f84\u6e05\uff1a\u201c\u5355\u9879\u5173\u952e\u8bd5\u9a8c\u201d\u2260\u201c\u5355\u81c2\u8bd5\u9a8c\u201d<\/strong><strong><br><\/strong><br>\u201c\u5355\u9879\u5173\u952e\u8bd5\u9a8c\uff08One Pivotal Trial\uff09\u201d\u8bf4\u7684\u662f\u6570\u91cf\uff1aFDA\u5141\u8bb8\u4ec5\u505a\u4e00\u9879\u201c\u5145\u5206\u4e14\u6709\u826f\u597d\u5bf9\u7167\u7684\u7814\u7a76\u201d\uff08\u901a\u5e38\u542b\u5bf9\u7167\u7ec4\uff09\uff0c\u4ee5\u66ff\u4ee3\u8fc7\u53bb\u9ed8\u8ba4\u7684\u4e24\u9879\u8bd5\u9a8c\u3002<\/p>\n\n\n\n<p><br>\u201c\u5355\u81c2\u8bd5\u9a8c\uff08SAT\uff09\u201d\u8bf4\u7684\u662f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u7ed3\u6784\uff1aCDE\u63a2\u8ba8\u7684\u662f\u8bd5\u9a8c\u672c\u8eab\u6ca1\u6709\u5bf9\u7167\u7ec4\uff0c\u4ec5\u6709\u6cbb\u7597\u81c2\u3002<\/p>\n\n\n\n<p>\u4e8c\u8005\u4ea4\u96c6\uff1a\u867d\u7136\u6982\u5ff5\u4e0d\u540c\uff0c\u4f46\u4e2d\u7f8e\u7684\u76d1\u7ba1\u7cbe\u795e\u6b8a\u9014\u540c\u5f52\u2014\u2014\u7528\u66f4\u5c11\u7684\u8bd5\u9a8c\u52a0\u901f\u7f55\u89c1\/\u91cd\u5371\u75be\u75c5\u65b0\u836f\u4e0a\u5e02\uff0c\u4f46\u5bf9\u5355\u4e00\u8bc1\u636e\u7684\u8d28\u91cf\u548c\u786e\u8bc1\u6027\u8981\u6c42\u7a7a\u524d\u63d0\u9ad8\u3002<\/p>\n\n\n\n<p>2023\u5e743\u6708\uff0cCDE\u53d1\u5e03\u300a\u5355\u81c2\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u652f\u6301\u6297\u80bf\u7624\u836f\u4e0a\u5e02\u7533\u8bf7\u7684\u9002\u7528\u6027\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b<sup>[2]<\/sup>\u3002\u8fd9\u4efd\u6587\u4ef6\u660e\u786e\u4e86\u5355\u81c2\u8bd5\u9a8c\u7684\u9002\u7528\u573a\u666f\uff1a\u5728\u4e25\u91cd\u5371\u53ca\u751f\u547d\u4e14\u5c1a\u65e0\u6709\u6548\u6cbb\u7597\u624b\u6bb5\u7684\u96be\u6cbb\u75be\u75c5\u80cc\u666f\u4e0b\uff0c\u5177\u6709\u7a81\u7834\u6027\u7597\u6548\u7684\u5355\u836f\u6cbb\u7597\u3002<\/p>\n\n\n\n<p>\u7d27\u63a5\u7740\uff0c2025\u5e7412\u6708\uff0cCDE\u8fdb\u4e00\u6b65\u53d1\u5e03\u300a\u5355\u81c2\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u652f\u6301\u6297\u80bf\u7624\u836f\u7269\u5e38\u89c4\u4e0a\u5e02\u7533\u8bf7\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b<sup>[3]<\/sup>\uff0c\u5c06\u5355\u81c2\u8bd5\u9a8c\u7684\u5e94\u7528\u4ece\u201c\u9644\u6761\u4ef6\u6279\u51c6\u201d\u5ef6\u4f38\u81f3\u201c\u5e38\u89c4\u4e0a\u5e02\u201d\u7684\u8ba8\u8bba\u8303\u7574\u3002\u8fd9\u610f\u5473\u7740\uff0c\u4e2d\u56fd\u76d1\u7ba1\u673a\u6784\u6b63\u5728\u7cfb\u7edf\u6027\u5730\u601d\u8003\uff1a\u5f53\u5355\u81c2\u8bd5\u9a8c\u6570\u636e\u8db3\u591f\u575a\u5b9e\uff0c\u662f\u5426\u53ef\u4ee5\u4f5c\u4e3a\u5e38\u89c4\u6279\u51c6\u7684\u57fa\u77f3\uff1f<\/p>\n\n\n\n<p>\u8fd9\u4e0eFDA\u65b0\u653f\u7684\u201c\u52a0\u901f\u6025\u9700\u836f\u7269\u4e0a\u5e02\u201d\u4e0a\u7684\u521d\u8877\u5982\u51fa\u4e00\u8f99\u2014\u2014\u4f46\u5728\u5177\u4f53\u8def\u5f84\u4e0a\uff0c\u56fd\u5185\u76d1\u7ba1\u5728\u63a2\u7d22\u514d\u9664\u5bf9\u7167\u7ec4\u7684\u5355\u81c2\u8bd5\u9a8c\u65f6\uff0c\u5176\u5ba1\u614e\u4e4b\u5904\u5728\u4e8e\u5bf9\u5176\u201c\u53ef\u884c\u6027\u201d\u63d0\u51fa\u4e86\u91cf\u5316\u7684\u95e8\u69db\u8981\u6c42\uff1a<\/p>\n\n\n\n<p>\u524d\u671f\u6709\u6548\u6027\u6570\u636e\u6837\u672c\u91cf\uff1a\u5728\u53d1\u75c5\u7387\u76f8\u5bf9\u8f83\u9ad8\u7684\u4eba\u7fa4\uff0c\u8981\u6c42\u5177\u590750-60\u4f8b\u5173\u952e\u8bd5\u9a8c\u5242\u91cf\u53d7\u8bd5\u8005\u7684\u6709\u6548\u6027\u8bc1\u636e\uff1b\u5373\u4f7f\u662f\u53d1\u75c5\u7387\u8f83\u4f4e\u7684\u7f55\u89c1\u4e9a\u578b\uff0c\u4e5f\u5e94\u8981\u6c4220-30\u4f8b\u53d7\u8bd5\u8005\u7684\u8bc1\u636e\u3002<\/p>\n\n\n\n<p>IRC\u72ec\u7acb\u8bc4\u4f30\uff1a\u8981\u6c42\u4ee5\u72ec\u7acb\u8bc4\u5ba1\u59d4\u5458\u4f1a\u8bc4\u4f30\u7684\u6709\u6548\u6027\u4f5c\u4e3a\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\uff0c\u786e\u4fdd\u8bc4\u4f30\u7ed3\u679c\u7684\u72ec\u7acb\u6027\u3001\u5ba2\u89c2\u6027\u548c\u7a33\u5b9a\u6027\u3002<\/p>\n\n\n\n<p>\u8fd9\u662f\u5bf9\u201c\u5355\u4e00\u8bc1\u636e\u201d\u8d28\u91cf\u7684\u4e2d\u56fd\u5f0f\u5b9a\u4e49\uff1a\u4e0d\u662f\u5141\u8bb8\u4f60\u5c11\u505a\u8bd5\u9a8c\uff0c\u800c\u662f\u8981\u6c42\u4f60\u5728\u6709\u9650\u6837\u672c\u4e2d\u62ff\u51fa\u7ecf\u5f97\u8d77\u63a8\u6572\u7684\u8bc1\u636e\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. \u9644\u6761\u4ef6\u6279\u51c6\uff1a4\u5e74\u5012\u8ba1\u65f6\u4e0b\u7684\u201c\u65f6\u95f4\u538b\u5f3a\u201d<\/strong><strong><\/strong><\/h3>\n\n\n\n<p>\u5982\u679c\u8bf4FDA\u65b0\u653f\u662f\u201c\u653e\u5bbd\u6570\u91cf\u8981\u6c42\u201d\uff0c\u90a3\u4e48\u56fd\u5185\u8fd1\u5e74\u6765\u5bf9\u9644\u6761\u4ef6\u6279\u51c6\u7684\u6536\u7d27\uff0c\u5219\u662f\u53e6\u4e00\u79cd\u7ef4\u5ea6\u7684\u201c\u8d28\u91cf\u5012\u903c\u201d\u3002<\/p>\n\n\n\n<p>2023\u5e749\u6708\uff0c\u300a\u836f\u54c1\u9644\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02\u7533\u8bf7\u5ba1\u8bc4\u5ba1\u6279\u5de5\u4f5c\u7a0b\u5e8f\uff08\u8bd5\u884c\uff09\u300b\u4fee\u8ba2\u7a3f<sup>[4]<\/sup>\u5f15\u53d1\u884c\u4e1a\u9707\u52a8\u3002\u6838\u5fc3\u53d8\u5316\u662f\uff1a\u9644\u6761\u4ef6\u83b7\u6279\u4e0a\u5e02\u7684\u836f\u54c1\uff0c\u539f\u5219\u4e0a\u8981\u57284\u5e74\u5185\u5b8c\u6210\u786e\u8bc1\u6027\u7814\u7a76\u3002<\/p>\n\n\n\n<p>\u8fd94\u5e74\uff0c\u88ab\u4e1a\u5185\u79f0\u4e3a\u201c\u751f\u6b7b\u5012\u8ba1\u65f6\u201d\u3002\u82e5\u65e0\u6cd5\u6309\u671f\u5b8c\u6210\uff0c\u4e14\u4e0d\u6ee1\u8db3\u201c\u6cbb\u7597\u9886\u57df\u4ecd\u65e0\u6709\u6548\u6cbb\u7597\u624b\u6bb5\u3001\u5df2\u5b8c\u6210\u5168\u90e8\u53d7\u8bd5\u8005\u5165\u7ec4\u3001\u7efc\u5408\u83b7\u76ca\u5927\u4e8e\u98ce\u9669\u201d\u4e09\u4e2a\u6761\u4ef6\uff0c\u836f\u54c1\u5c06\u9762\u4e34\u64a4\u5e02\u98ce\u9669\u3002<\/p>\n\n\n\n<p>\u8fd9\u610f\u5473\u7740\u4ec0\u4e48\uff1f<\/p>\n\n\n\n<p>\u610f\u5473\u7740\u90a3\u4e9b\u5e0c\u671b\u901a\u8fc7\u201c\u5355\u9879\u8bd5\u9a8c\u201d\u6216\u201c\u5355\u81c2\u8bd5\u9a8c\u201d\u5feb\u901f\u9644\u6761\u4ef6\u4e0a\u5e02\u7684\u4f01\u4e1a\uff0c\u5fc5\u987b\u5728\u8bbe\u8ba1\u4e4b\u521d\u5c31\u60f3\u6e05\u695a\uff1a\u4e0a\u5e02\u540e\u7684\u786e\u8bc1\u6027\u7814\u7a76\u600e\u4e48\u505a\uff1f\u60a3\u8005\u5165\u7ec4\u80fd\u5426\u4fdd\u969c\uff1f\u8d44\u91d1\u80fd\u5426\u652f\u6491\uff1f\u5982\u679c\u8fd9\u4e9b\u95ee\u9898\u6ca1\u6709\u7b54\u6848\uff0c\u8fd9\u79cd\u964d\u4f4e\u65e9\u671f\u95e8\u69db\u6240\u5e26\u6765\u7684\u201c\u901f\u5ea6\u7ea2\u5229\u201d\uff0c\u53ef\u80fd\u57284\u5e74\u540e\u53d8\u6210\u201c\u64a4\u5e02\u5371\u673a\u201d\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. 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class=\"wp-block-heading\">PART 02<br>\u4e2d\u56fd\u7279\u8272\u7684\u201c\u8d28\u91cf\u9769\u547d\u201d\uff1a\u5728\u653f\u7b56\u7ec4\u5408\u62f3\u4e2d\u5bfb\u627e\u6700\u4f18\u89e3<\/h2>\n\n\n\n<p>\u5c06FDA\u65b0\u653f\u653e\u5728\u4e2d\u56fd\u76d1\u7ba1\u653f\u7b56\u7684\u5750\u6807\u7cfb\u4e2d\uff0c\u6211\u4eec\u4f1a\u53d1\u73b0\uff1a\u56fd\u5185\u521b\u65b0\u836f\u7814\u53d1\u9762\u4e34\u7684\u4e0d\u662f\u5355\u4e00\u653f\u7b56\u7684\u51b2\u51fb\uff0c\u800c\u662f\u4e00\u5957\u653f\u7b56\u7ec4\u5408\u62f3\u7684\u7cfb\u7edf\u6027\u8003\u9a8c\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. 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class=\"wp-block-heading\"><strong>2. 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class=\"wp-block-heading\"><strong>3. 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class=\"wp-block-heading\">PART 03<br>\u7ed3\u8bed\uff1a\u5728\u201c\u5200\u5203\u65f6\u4ee3\u201d\uff0c\u9009\u62e9\u771f\u6b63\u61c2\u76d1\u7ba1\u903b\u8f91\u7684\u4f19\u4f34<\/h2>\n\n\n\n<p>FDA\u65b0\u653f\u4e0d\u662f\u5b64\u7acb\u4e8b\u4ef6\u3002\u5b83\u4e0eCDE\u8fd1\u5e74\u6765\u7684\u4e00\u7cfb\u5217\u653f\u7b56\u6539\u9769\uff0c\u5171\u540c\u6307\u5411\u4e00\u4e2a\u6e05\u6670\u7684\u672a\u6765\uff1a\u521b\u65b0\u836f\u7814\u53d1\u7684\u7ade\u4e89\uff0c\u6b63\u5728\u4ece\u201c\u62fc\u901f\u5ea6\u201d\u8f6c\u5411\u201c\u62fc\u8d28\u91cf\u201d\u3002<\/p>\n\n\n\n<p>\u5728\u7f8e\u56fd\uff0c\u8d28\u91cf\u4f53\u73b0\u5728\u201c\u4e00\u9879\u5173\u952e\u8bd5\u9a8c+\u786e\u8bc1\u6027\u8bc1\u636e\u201d\u7684\u5ba1\u8bc4\u903b\u8f91\u3002<\/p>\n\n\n\n<p>\u5728\u4e2d\u56fd\uff0c\u8d28\u91cf\u4f53\u73b0\u5728\u201c\u5355\u81c2\u8bd5\u9a8c\u53ef\u884c\u6027\u8bba\u8bc1+4\u5e74\u786e\u8bc1\u6027\u5012\u8ba1\u65f6+\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u7ec8\u70b9\u8bbe\u8ba1\u201d\u7684\u653f\u7b56\u7ec4\u5408\u3002<\/p>\n\n\n\n<p>\u5bf9\u4e8e\u90a3\u4e9b\u771f\u6b63\u505a\u521b\u65b0\u836f\u7684\u4f01\u4e1a\u6765\u8bf4\uff0c\u8fd9\u662f\u597d\u6d88\u606f\u2014\u2014\u56e0\u4e3a\u4f60\u7684\u4ea7\u54c1\uff0c\u7ec8\u4e8e\u53ef\u4ee5\u7528\u4e00\u9879\u8bbe\u8ba1\u7cbe\u826f\u7684\u9ad8\u8d28\u91cf\u5173\u952e\u8bd5\u9a8c\u8bc1\u660e\u81ea\u5df1\uff0c\u800c\u4e0d\u5fc5\u5728\u91cd\u590d\u4e2d\u6d88\u8017\u65f6\u95f4\u548c\u8d44\u672c\u3002<\/p>\n\n\n\n<p>\u4f46\u524d\u63d0\u662f\uff0c\u4f60\u5fc5\u987b\u627e\u5230\u90a3\u4e2a\u771f\u6b63\u61c2\u201c\u8d28\u91cf\u201d\u3001\u80fd\u591f\u4ece\u201c\u79d1\u5b66\u6027\u201d\u6e90\u5934\u8fdb\u884c\u65b9\u6848\u8bbe\u8ba1\u3001\u80fd\u591f\u7528\u4e13\u4e1a\u80fd\u529b\u62a4\u822a\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5408\u4f5c\u4f19\u4f34\u3002<\/p>\n\n\n\n<p>\u5728\u201c\u5355\u4e00\u6838\u5fc3\u8bc1\u636e\u201d\u5b9a\u751f\u6b7b\u7684\u65f6\u4ee3\uff0c\u5e02\u573a\u7ade\u4e89\u6fc0\u70c8\u8d8b\u5411\u767d\u70ed\u5316\uff0c\u5bb9\u9519\u7387\u51e0\u4e4e\u4e3a\u96f6\u7684\u3002\u9009\u62e9\u4e34\u5e8aCRO\u5408\u4f5c\u4f19\u4f34\uff0c\u672c\u8d28\u4e0a\u5c31\u662f\u5728\u4e3a\u90a3\u4efd\u201c\u552f\u4e00\u7684\u8bc1\u636e\u201d\u9009\u62e9\u5b88\u62a4\u8005\u3002\u800c\u5728\u8fd9\u4e2a\u201c\u5200\u5203\u65f6\u4ee3\u201d\uff0c\u771f\u6b63\u61c2\u76d1\u7ba1\u89c4\u5219\u3001\u6709\u5b9e\u6218\u79ef\u6dc0\u7684\u5b88\u62a4\u8005\uff0c\u6b63\u5728\u6210\u4e3a\u6700\u7a00\u7f3a\u7684\u8d44\u6e90\u3002<\/p>\n\n\n\n<p>\u5982\u60a8\u9700\u8981\u63a2\u8ba8\u8bdd\u9898\uff0c\u6b22\u8fce\u5728\u8bc4\u8bba\u533a\u6216\u662f\u79c1\u4fe1\u4e2d\u4e0e\u6211\u4eec\u4ea4\u6d41\u3002<\/p>\n\n\n\n<p>\u4e5f\u5341\u5206\u6b22\u8fce\u60a8\u76f4\u63a5\u8054\u7cfb\u6211\u4eec\uff0c\u65b9\u5f0f\u5982\u4e0b\uff1a<\/p>\n\n\n\n<p>\u8054\u7cfb\u7535\u8bdd\uff1a13758291914\uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/p>\n\n\n\n<p>\u5546\u52a1\u90ae\u7bb1\uff1azym@millibuff.com<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u53c2\u8003\u6587\u732e\u00a0<\/h2>\n\n\n\n<p><br>1.Prasad V, Makary MA. One Pivotal Trial, the New Default Option for FDA Approval \u2014 Ending the Two-Trial Dogma. N Engl J Med. 2026;394(8):815-817.<\/p>\n\n\n\n<p>2.\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3. \u5355\u81c2\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u652f\u6301\u6297\u80bf\u7624\u836f\u4e0a\u5e02\u7533\u8bf7\u7684\u9002\u7528\u6027\u6280\u672f\u6307\u5bfc\u539f\u5219 [S]. 2023.<\/p>\n\n\n\n<p>3.\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3. \u5355\u81c2\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u652f\u6301\u6297\u80bf\u7624\u836f\u7269\u5e38\u89c4\u4e0a\u5e02\u7533\u8bf7\u6280\u672f\u6307\u5bfc\u539f\u5219 [S]. 2025.<\/p>\n\n\n\n<p>4.\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08\u539f\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff09. \u836f\u54c1\u9644\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02\u7533\u8bf7\u5ba1\u8bc4\u5ba1\u6279\u5de5\u4f5c\u7a0b\u5e8f\uff08\u8bd5\u884c\uff09[S]. 2020.<\/p>\n\n\n\n<p>5.\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3. \u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u4e2d\u836f\u65b0\u836f\u4e34\u5e8a\u7814\u53d1\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09[S]. 2024.<\/p>\n\n\n\n<p>6.Nugent BM, Thomas A, Bagheri B, et al. Confirmatory Evidence Used in Non-Oncologic Rare Disease New Molecular Entity Marketing Applications Approved by FDA, 2020-2023. Clinical Pharmacology &amp; Therapeutics. 2025 Jun;117(6):1627-1631.<\/p>\n\n\n\n<p>7.Brown BL, et al. Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review. Journal of Health Politics, Policy and Law. 2022 Dec 1;47(6):649-672.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>\u64b0\u7a3f\u4eba\uff1a\u90d1\u53f6\u654f<\/p>\n\n\n\n<p>\u5ba1\u6838\uff1a\u5bab\u96ea<\/p>\n\n\n\n<p>\u6da6\u8272\u6392\u7248\uff1a\u5468\u5b89\u6960<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u672c\u6587\u56f4\u7ed5FDA\u201c\u4e00\u9879\u5173\u952e\u4e34\u5e8a\u8bd5\u9a8c+\u786e\u8bc1\u6027\u8bc1\u636e\u201d\u65b0\u653f\u53ca\u5176\u5bf9\u4e2d\u56fd\u521b\u65b0\u836f\u7814\u53d1\u7684\u5f71\u54cd\uff0c\u805a\u7126\u4ee5\u4e0b\u56db\u5927\u6838\u5fc3\u95ee\u9898\u5c55\u5f00\u8bba\u8ff0\uff1a\u76d1\u7ba1\u653f\u7b56\u53d8\u9769\u7684\u672c\u8d28\u95ee\u9898\u3001\u56fd\u5185\u76d1\u7ba1\u73af\u5883\u4e0b\u7684\u9002\u914d\u6027\u95ee\u9898\u3001\u4e34\u5e8a\u5f00\u53d1\u5b9e\u8df5\u7684\u64cd\u4f5c\u6027\u95ee\u9898\u548c\u4e2d\u56fd\u521b\u65b0\u836f\u4f01\u7684\u5e94\u5bf9\u7b56\u7565\u95ee\u9898\u3002<\/p>\n","protected":false},"author":1,"featured_media":1705,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[101,109,110,35,86,15,111,32,34,29],"class_list":["post-1704","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-fda","tag-109","tag-110","tag-35","tag-86","tag-15","tag-111","tag-32","tag-34","tag-29"],"_links":{"self":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1704","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1704"}],"version-history":[{"count":1,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1704\/revisions"}],"predecessor-version":[{"id":1707,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1704\/revisions\/1707"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/media\/1705"}],"wp:attachment":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1704"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1704"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1704"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}