{"id":57905,"date":"2018-11-13T01:00:00","date_gmt":"2018-12-07T02:28:24","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/2a2d19159b\/"},"modified":"2018-12-07T10:28:33","modified_gmt":"2018-12-07T02:28:33","slug":"2a2d19159b","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57905\/","title":{"rendered":"\u5e72\u8d27 | \u65b0\u836fI\u671f\u3001II\u671f\u3001III\u671f\u4e4b\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8def\u5f84"},"content":{"rendered":"
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\u60f3\u6bcf\u5929\u6536\u5230\u7c7b\u4f3c\u6d88\u606f\uff0c\u5c31\u7f6e\u9876\u201c<\/span>\u201d\u548c\u5206\u4eab\u5230\u670b\u53cb\u5708\u5427\uff01<\/span><\/strong><\/p>\n

\u6587\u7ae0\u6765\u6e90\uff1a\u3001<\/span><\/p>\n


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\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8def\u5f84\uff1aI\u671f\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/strong><\/p>\n

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1<\/p>\n<\/section>\n

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\u80cc\u666f\u77e5\u8bc6<\/strong><\/p>\n<\/section>\n<\/h2>\n

\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u82f1\u6587\u4e3aclinical trial\uff0c\u800c\u4e0d\u662fclinical experiment\u3002\u5b66\u836f\u7ae5\u978b\u80af\u5b9a\u6216\u591a\u6216\u5c11\u505a\u8fc7\u5404\u79cd\u5b9e\u9a8c\uff0c\u4e0d\u7ba1\u662f\u5316\u5b66\u5b9e\u9a8c\u3001\u751f\u7269\u5b9e\u9a8c\u8fd8\u662f\u5236\u5242\u5b9e\u9a8c\u3001\u836f\u7406\u5b9e\u9a8c\uff0c\u7528\u7684\u90fd\u662f\u201c\u5b9e\u9a8c\u201d\u4e8c\u5b57\u3002\u6240\u8c13\u201c\u5b9e\u9a8c\u201d\uff0c\u300a\u73b0\u4ee3\u6c49\u8bed\u8bcd\u5178\u300b\u7684\u5b9a\u4e49\u662f\u4e3a\u4e86\u68c0\u9a8c\u67d0\u79cd\u79d1\u5b66\u7406\u8bba\u6216\u5047\u8bbe\u800c\u8fdb\u884c\u67d0\u79cd\u64cd\u4f5c\u6216\u4ece\u4e8b\u67d0\u79cd\u6d3b\u52a8\uff1b\u800c\u201c\u8bd5\u9a8c\u201d\u662f\u4e3a\u4e86\u5bdf\u770b\u67d0\u4e8b\u7684\u7ed3\u679c\u6216\u67d0\u7269\u7684\u6027\u80fd\u800c\u4ece\u4e8b\u67d0\u79cd\u6d3b\u52a8\u3002\u800c\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u662f\u4e3a\u4e86\u8003\u5bdf\u65b0\u836f\u5bf9\u76ee\u6807\u60a3\u8005\u7684\u6548\u7528\u800c\u5c55\u5f00\u7684\u4e00\u7cfb\u5217\u7684\u8bd5\u9a8c\uff0c\u672c\u7cfb\u5217\u6587\u7ae0\u5c31\u548c\u5927\u5bb6\u8bb2\u8bb2\u65b0\u836f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/p>\n

\u65b0\u53d1\u8fc7\u7a0b\u4e3b\u8981\u5305\u62ec\u82d7\u5934\u5206\u5b50\u7684\u53d1\u73b0\u3001\u7ec6\u80de\u6d3b\u6027\u8bc4\u4ef7\u3001\u975e\u4e34\u5e8a\u836f\u7406\u6bd2\u7406\u7814\u7a76\u3001\u4e34\u5e8a\u8bd5\u9a8c\u548c\u4e0a\u5e02\u540e\u7684\u5b89\u5168\u6027\u76d1\u7763\u3002\u5176\u4e2d\u4e34\u5e8a\u8bd5\u9a8c\u8017\u8d44\/\u8017\u65f6\u57fa\u672c\u5360\u6574\u4e2a\u65b0\u836f\u5f00\u53d1\u768460%~80%\uff0c\u53ef\u8c13\u662f\u65b0\u836f\u5f00\u53d1\u6700\u8017\u94b1\u8017\u65f6\u7684\u9636\u6bb5\u3002FDA\u5c06\u4e34\u5e8a\u7814\u7a76\u5206\u4e3a\u4e09\u671f\uff0c\u8fd9\u4e09\u671f\u4e34\u5e8a\u7814\u7a76\u901a\u5e38\u6309\u671f\u4f9d\u6b21\u5b9e\u65bd\uff0c\u4f46\u4e5f\u53ef\u4ee5\u6709\u91cd\u53e0\uff1b\u53e6\u5916\u9488\u5bf9\u65b0\u836f\u6279\u51c6\u4e0a\u5e02\u540e\u7684\u4e34\u5e8a\u7814\u7a76\uff0cFDA\u5b9a\u4e49\u5176\u4e3aIV\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002ICHE8\u6839\u636e\u4e34\u5e8a\u7814\u7a76\u7684\u76ee\u7684\u5c06\u4e34\u5e8a\u8bd5\u9a8c\u540c\u6837\u5206\u4e3a4\u671f\u3002<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

2006\u5e74\uff0cFDA\u53d1\u5e03\u4e86\u300aGuidance for industry\uff0c investigators and reviewers exploratory IND studies\u300b\uff0c\u63d0\u51fa0\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6982\u5ff5\uff0c\u5176\u53d7\u8bd5\u8005\u66f4\u5c11(\u226410\u4f8b)\uff0c\u7814\u7a76\u5468\u671f\u66f4\u77ed(\u22647\u5929)\uff0c\u7528\u4e8e\u63a2\u7d22\u65b0\u836f\u5728\u4eba\u4f53\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u548c\u836f\u6548\u5b66\u7814\u7a76\uff0c\u4e3aI\u671f\u4e34\u5e8a\u63d0\u4f9b\u6307\u5bfc\u3002\u4e0d\u7ba1\u662f0\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6982\u5ff5\uff0c\u8fd8\u662f\u4f20\u7edf\u4e09\u5206\u6cd5\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5176\u5206\u671f\u7684\u76ee\u7684\u662f\u57fa\u4e8e\u98ce\u9669\u63a7\u5236\u7684\u54f2\u5b66\u89c2\u3002I\u671f\u4e34\u5e8a\u901a\u5e38\u91c7\u7528\u5c11\u91cf(\u6570\u5341\u4eba)\u5065\u5eb7\u5fd7\u613f\u8005\u4f5c\u4e3a\u53d7\u8bd5\u8005\uff0c\u76f8\u8f83\u4e8e\u91c7\u7528\u8f83\u591a\u60a3\u8005\u4f5c\u4e3a\u53d7\u8bd5\u8005\u7684II\u671f\u4ee5\u53ca\u66f4\u5927\u6837\u672c\u91cf\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u800c\u8a00\uff0c\u5177\u6709\u6210\u672c\u4f4e(\u4eba\u5c11)\uff0c\u65f6\u95f4\u77ed(\u53ef\u4f9b\u7684\u5065\u5eb7\u53d7\u8bd5\u8005\u4f17\u591a)\u548c\u4f4e\u98ce\u9669(\u5065\u5eb7\u53d7\u8bd5\u8005\u8eab\u4f53\u62b5\u6297\u529b\u8f83\u5f3a)\u7b49\u7279\u70b9\u3002<\/span><\/p>\n

\n
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2<\/p>\n<\/section>\n

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I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5168\u666f<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

2.1 \u662f\u4ec0\u4e48(Who)<\/span><\/strong><\/p>\n

I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u662f\u5728\u52a8\u7269\u836f\u7406\u6bd2\u7406\u8bd5\u9a8c\u57fa\u672c\u6210\u529f\u7684\u57fa\u7840\u4e0a\uff0c\u9996\u6b21\u5e94\u7528\u5728\u4eba\u4f53\u4e0a\uff0c\u7528\u6765\u521d\u6b65\u8bc4\u4ef7\u65b0\u836f\u7684\u4eba\u4f53\u8010\u53d7\u6027\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u3002<\/span><\/p>\n


<\/p>\n

2.2 \u4e3a\u4ec0\u4e48(Why)<\/span><\/strong><\/span><\/p>\n

I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u8981\u76ee\u7684\u662f\u89c2\u5bdf\u968f\u4eba\u4f53\u7ed9\u836f\u5242\u91cf\u589e\u52a0\u800c\u51fa\u73b0\u526f\u4f5c\u7528\u7684\u60c5\u51b5\uff0c\u65b0\u836f\u5728\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u6027\u8d28\u4ee5\u53ca\u6536\u96c6\u6709\u6548\u6027\u7684\u65e9\u671f\u8bc1\u636e\u3002\u901a\u8fc7I\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u89c2\u5bdf\u4eba\u4f53\u5bf9\u65b0\u836f\u7684\u8010\u53d7\u7a0b\u5ea6\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u548c\u836f\u6548\u52a8\u529b\u5b66\uff0c\u63a2\u7d22\u836f\u7269\u6700\u5927\u8010\u53d7\u5242\u91cf(Maximal Tolerable Dose\uff0cMTD)\u3001\u5242\u91cf\u9650\u5236\u6027\u6bd2\u6027(Dose-Limiting Toxicity\uff0cDLT)\uff0c\u4e3a\u5236\u5b9a\u63a5\u4e0b\u6765II\u3001III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u7ed9\u836f\u65b9\u6848\u63d0\u4f9b\u4f9d\u636e\u3002<\/span><\/p>\n


<\/p>\n

2.3 \u505a\u4ec0\u4e48(What)<\/span><\/strong><\/span><\/p>\n

I\u671f\u4e34\u5e8a\u4e3b\u8981\u56de\u7b54\u4ee5\u4e0b\u4e24\u4e2a\u95ee\u9898\uff1a\u2460\u836f\u7269\u7684\u4e0d\u826f\u53cd\u5e94\u662f\u4ec0\u4e48\uff1b\u2462\u836f\u7269\u662f\u5982\u4f55\u88ab\u5438\u6536\u4ee3\u8c22\u7684\u3002\u4e3a\u56de\u7b54\u4ee5\u4e0a\u95ee\u9898\uff0cI\u671f\u4e34\u5e8a\u81f3\u5c11\u9700\u8981\u5b8c\u6210\u4ee5\u4e0b\u5173\u952e\u7814\u7a76\uff1a<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\u53e6\u5916\uff0cI\u671f\u4e34\u5e8a\u4e5f\u53ef\u4ee5\u540c\u6b65\u8003\u5bdf\u65b0\u836f\u7684\u4eba\u4f53\u836f\u6548\u5b66\u3001\u98df\u7269\u5f71\u54cd\u3001\u836f\u7269\u95f4\u76f8\u4e92\u4f5c\u7528\u7b49\u3002<\/span><\/p>\n


<\/p>\n

2.4 \u600e\u4e48\u505a(How)<\/span><\/strong><\/p>\n

\u8bd5\u9a8c\u987a\u5e8f\uff1a<\/span><\/strong>\u901a\u5e38\u4f9d\u6b21\u8fdb\u884c\u8010\u53d7\u6027\u5355\u5242\u91cf\u8bd5\u9a8c\u3001\u836f\u52a8\u5b66\u5355\u5242\u91cf\u8bd5\u9a8c\u3001\u591a\u5242\u91cf\u8010\u53d7\u6027\u548c\u836f\u52a8\u5b66\u8bd5\u9a8c\u3002\u5bf9\u4e8e\u91c7\u7528\u60a3\u8005\u8fdb\u884c\u7684I\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u548c\u836f\u52a8\u5b66\u8bd5\u9a8c\u53ef\u540c\u6b65\u8fdb\u884c\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u8bbe\u8ba1\u539f\u7406\uff1a<\/span><\/strong>I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5e38\u91c7\u7528\u5f00\u653e\u3001\u81ea\u8eab\u5bf9\u7167\u8bd5\u9a8c\u3002\u4f46\u5f53\u4e3b\u8981\u4e0d\u826f\u53cd\u5e94\u7f3a\u4e4f\u5ba2\u89c2\u6307\u6807\u6216\u4e0d\u5b9c\u5224\u5b9a\u4e0d\u826f\u53cd\u5e94\u4e0e\u836f\u7269\u5173\u7cfb\u65f6\uff0c\u5e38\u91c7\u7528\u968f\u673a\u76f2\u6cd5\u3001\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u53d7\u8bd5\u8005\uff1a<\/span><\/strong>\u591a\u9009\u7528\u5065\u5eb7\u5e74\u8f7b\u7684\u7537\u6027\u4f5c\u4e3a\u5fd7\u613f\u8005\u3002\u4f46\u7c7b\u4f3c\u7ec6\u80de\u6bd2\u836f\u7269\u7b49(\u5982\u6297\u80bf\u7624\u836f\u7269)\u5e94\u91c7\u7528\u60a3\u8005\u4f5c\u4e3a\u53d7\u8bd5\u8005\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u6837\u672c\u91cf\uff1a<\/span><\/strong>\u4e00\u822c\u4e3a20-80\u540d\u53d7\u8bd5\u8005\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u63a5\u4e0b\u6765\u4e3b\u8981\u4ecb\u7ecdI\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8def\u5f84\u3002<\/span><\/p>\n

<\/span><\/p>\n

\n
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3<\/p>\n<\/section>\n

\n

I\u671f\u4e34\u5e8a\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u8bbe\u8ba1<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u662f\u8003\u5bdf\u4eba\u4f53\u5bf9\u836f\u7269\u4e0d\u540c\u5242\u91cf\u7684\u8010\u53d7\u7a0b\u5ea6\uff0c\u901a\u8fc7\u8bd5\u9a8c\u53d1\u73b0\u51fa\u73b0\u4e0d\u826f\u53cd\u5e94\u6027\u8d28\u548c\u5242\u91cf\u3002I\u671f\u4e34\u5e8a\u7684\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u4e00\u822c\u5148\u8fdb\u884c\u5355\u5242\u91cf\u7684\u63a2\u7d22\uff0c\u5728\u6b64\u57fa\u7840\u4e0a\u786e\u5b9a\u662f\u5426\u8fdb\u884c\u591a\u5242\u91cf\u8bd5\u9a8c\u3002\u8bd5\u9a8c\u53ef\u4ee5\u662f\u5f00\u653e\u3001\u57fa\u7ebf\u5bf9\u7167\uff0c\u4e5f\u53ef\u4ee5\u91c7\u7528\u968f\u673a\u5316\u548c\u76f2\u6cd5\u63d0\u9ad8\u89c2\u5bdf\u7ed3\u679c\u7684\u51c6\u786e\u6027\u3002I\u671f\u4e34\u5e8a\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u603b\u4f53\u8bbe\u8ba1\u7406\u5ff5\uff1a\u4ece\u8d77\u59cb\u5242\u91cf\u5230\u6700\u5927\u5242\u91cf\u4e4b\u95f4\u8bbe\u82e5\u5e72\u7ec4\uff0c\u5404\u4e2a\u8bd5\u9a8c\u7ec4\u7684\u5242\u91cf\u7531\u5c0f\u5230\u5927\u9010\u7ec4\u8fdb\u884c\uff0c\u76f4\u81f3\u627e\u5230\u6700\u5927\u8010\u53d7\u5242\u91cf(MTD)\u6216\u5230\u8fbe\u8bbe\u8ba1\u7684\u6700\u5927\u5242\u91cf\u3002<\/span><\/p>\n


<\/p>\n

3.1 \u8d77\u59cb\u5242\u91cf<\/span><\/strong><\/p>\n

\u8d77\u59cb\u5242\u91cf\u662f\u6307\u4ece\u52a8\u7269\u5b9e\u9a8c\u8fc7\u6e21\u5230\u4eba\u4f53\u8bd5\u9a8c\u65f6\uff0c\u9996\u6b21\u5e94\u7528\u4e8e\u4eba\u4f53\u7684\u836f\u7269\u5242\u91cf\u3002\u4e3a\u786e\u5b9a\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5b89\u5168\u8d77\u59cb\u5242\u91cf\uff0c\u9700\u8981\u5145\u5206\u4e86\u89e3\u4e34\u5e8a\u524d\u52a8\u7269\u7684\u836f\u7406\u5b66\u3001\u6bd2\u7406\u5b66\u53ca\u836f\u52a8\u5b66\u6570\u636e\u3002\u786e\u5b9a\u8d77\u59cb\u5242\u91cf\u7684\u65b9\u6cd5\u4e3b\u8981\u6709\u4ee5\u4e0b5\u79cd\u3002<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\u8d77\u59cb\u5242\u91cf\u7684\u9009\u62e9\u5e94\u9075\u5faa\u4e24\u5927\u539f\u5219\uff1a\u2460\u907f\u514d\u6bd2\u6027\u53cd\u5e94\uff1b\u2461\u80fd\u591f\u5feb\u901f\u8fbe\u5230I\u671f\u4e34\u5e8a\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u7684\u8bc4\u4f30\u76ee\u6807\u3002<\/span><\/p>\n


<\/p>\n

3.2 \u6700\u5927\u5242\u91cf<\/span><\/strong><\/p>\n

\u6700\u5927\u8bbe\u8ba1\u5242\u91cf\u901a\u5e38\u6709\u4ee5\u4e0b\u4e09\u79cd\u65b9\u6cd5\u2460\u540c\u4e00\u836f\u7269\u3001\u540c\u7c7b\u836f\u7269\u6216\u7ed3\u6784\u76f8\u4f3c\u836f\u7269\u5355\u6b21\u6700\u5927\u5242\u91cf\uff1b\u2461\u52a8\u7269\u957f\u671f\u6bd2\u6027\u8bd5\u9a8c\u4e2d\u5f15\u8d77\u4e2d\u6bd2\u75c7\u72b6\u6216\u810f\u5668\u51fa\u73b0\u53ef\u9006\u6027\u53d8\u5316\u7684\u5242\u91cf\u76841\/10\uff1b\u2462\u52a8\u7269\u957f\u671f\u6bd2\u6027\u8bd5\u9a8c\u4e2d\u6700\u5927\u8010\u53d7\u91cf\u76841\/5\uff5e1\/2\u3002\u6700\u5927\u5242\u91cf\u8303\u56f4\u5185\u5e94\u5305\u62ec\u9884\u671f\u7684\u6709\u6548\u5242\u91cf\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5982\u8bd5\u9a8c\u8fbe\u5230\u6700\u5927\u5242\u91cf\u53d7\u8bd5\u8005\u4ecd\u65e0\u4e0d\u826f\u53cd\u5e94\u65f6\uff0c\u8bd5\u9a8c\u5373\u53ef\u7ed3\u675f\u3002\u5242\u91cf\u9012\u589e\u5230\u51fa\u73b0\u7ec8\u6b62\u6307\u6807\u6216\u5176\u4ed6\u8f83\u4e25\u91cd\u7684\u4e0d\u826f\u53cd\u5e94\u65f6\uff0c\u867d\u672a\u8fbe\u5230\u6700\u5927\u5242\u91cf\uff0c\u4e5f\u5e94\u7ec8\u6b62\u8bd5\u9a8c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

3.3 \u5242\u91cf\u9012\u589e\u8bbe\u8ba1(\u722c\u5761\u8bd5\u9a8c)<\/span><\/strong><\/p>\n

\u5728\u786e\u5b9a\u4e86\u8d77\u59cb\u5242\u91cf\u548c\u6700\u5927\u5242\u91cf\u540e\uff0c\u9700\u8981\u8bbe\u8ba1\u5242\u91cf\u9012\u589e\u65b9\u6848\uff0c\u4ee5\u4fbf\u5f00\u5c55\u5242\u91cf\u9012\u589e\u7684\u722c\u5761\u8bd5\u9a8c\u3002\u5242\u91cf\u9012\u589e\u65b9\u6848\u7684\u786e\u5b9a\u8981\u8003\u8651\u8d77\u59cb\u5242\u91cf\u4e0e\u836f\u6548\u5b66\u6709\u6548\u5242\u91cf\u548c\u6bd2\u6027\u5242\u91cf\u4e4b\u95f4\u7684\u8ddd\u79bb\u3001\u6bd2\u4ee3\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u5f81\u7b49\u56e0\u7d20\u3002\u901a\u5e38\u91c7\u7528\u8d39\u6c0f\u9012\u589e\u6cd5(\u6539\u826f\u7684Fibonacci\u6cd5)\u8bbe\u8ba1\u5242\u91cf\u722c\u5761\u65b9\u6848\uff0c\u5373\u5f53\u521d\u8bd5\u5242\u91cf\u4e3an (g\/m<\/span>2<\/sup><\/span>)\u65f6\uff0c\u5176\u540e\u6309\u987a\u5e8f\u9012\u589e\u7684\u5242\u91cf\u5206\u522b\u662f2n\u30013.3n\u30015n\u30017n\uff0c\u6b64\u540e\u5219\u4f9d\u6b21\u9012\u589e\u524d\u4e00\u5242\u91cf\u76841\/3\u3002\u5176\u7279\u70b9\u662f\u5f00\u59cb\u9012\u589e\u901f\u5ea6\u5feb\uff0c\u540e\u671f\u589e\u901f\u8f83\u6162\uff0c\u5728\u786e\u4fdd\u53d7\u8bd5\u8005\u5b89\u5168\u7684\u60c5\u51b5\u4e0b\uff0c\u4ee5\u5408\u7406\u7684\u901f\u5ea6\u548c\u68af\u5ea6\u8fc5\u901f\u8fbe\u5230\u8010\u53d7\u6027\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ec8\u6b62\u76ee\u6807\u3002<\/span><\/p>\n


<\/p>\n

\u53e6\u5916\u5242\u91cf\u9012\u589e\u8bbe\u8ba1\u8fd8\u6709\u56fa\u5b9a\u6bd4\u4f8b\u9012\u589e\u6cd5\uff0c\u5373\u5242\u91cf\u6309\u7167\u56fa\u5b9a\u6bd4\u4f8b\u9012\u589e\uff0c\u4f46\u4e34\u5e8a\u5b9e\u9645\u5e94\u7528\u8f83\u5c11\u3002<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\"\u5e72\u8d27<\/p>\n

\u5bf9\u4e8e\u5242\u91cf\u9012\u589e\uff0c\u4e5f\u53ef\u6839\u636e\u5177\u4f53\u836f\u7269\u7684\u81ea\u8eab\u7279\u70b9\uff0c\u8bbe\u8ba1\u66f4\u5177\u9488\u5bf9\u6027\u7684\u5242\u91cf\u9012\u589e\u65b9\u6848\u3002\u5242\u91cf\u9012\u589e\u7684\u57fa\u672c\u539f\u5219\uff1a\u521d\u671f\u9012\u589e\u5e45\u5ea6\u53ef\u8f83\u5927\uff0c\u540e\u671f\u9012\u589e\u5e45\u5ea6\u5e94\u8f83\u5c0f\u3002\u9012\u589e\u7cfb\u6570\u8fc7\u5c0f\uff0c\u4f1a\u589e\u52a0\u4e0d\u5fc5\u8981\u7684\u53d7\u8bd5\u8005\u4f8b\u6570\uff1b\u9012\u589e\u7cfb\u6570\u8fc7\u5927\uff0c\u4f1a\u589e\u52a0\u53d7\u8bd5\u8005\u7684\u5371\u9669\u6027\u3002\u5b89\u5168\u6027\u5927\u6216\u6bd2\u6027\u5c0f\u7684\u836f\u7269\u5242\u91cf\u9012\u589e\u5e45\u5ea6\u53ef\u5927\uff0c\u6709\u7684\u53ef\u6210\u500d\u9012\u589e\uff1b\u5b89\u5168\u6027\u5c0f\u6216\u6bd2\u6027\u8f83\u5927\u7684\u836f\u7269\u5242\u91cf\u9012\u589e\u5e45\u5ea6\u5e94\u5c0f\u3002<\/span><\/p>\n


<\/p>\n

3.4 \u6700\u5927\u8010\u53d7\u5242\u91cf(MTD)\u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/strong><\/p>\n

I\u671f\u4e34\u5e8a\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u7684\u76ee\u6807\u662f\u786e\u5b9a\u4eba\u4f53\u7684\u6700\u5927\u8010\u53d7\u5242\u91cf\u3002\u5728\u7ed9\u5b9a\u8d77\u59cb\u5242\u91cf\u3001\u6700\u5927\u5242\u91cf\u548c\u9012\u589e\u5242\u91cf\u7684\u524d\u63d0\u4e0b\uff0c\u6211\u4eec\u901a\u8fc7\u8bbe\u8ba1\u8bd5\u9a8c\u65b9\u6848\u6765\u786e\u5b9a\u4eba\u4f53\u7684\u6700\u5927\u8010\u53d7\u5242\u91cf\u3002\u786e\u5b9a\u6700\u5927\u8010\u53d7\u5242\u91cf\u7684\u65b9\u6cd5\u4e00\u822c\u6709\u4e24\u5927\u7c7b\uff1a\u57fa\u4e8e\u89c4\u5219\u7684\u8bd5\u9a8c\u8bbe\u8ba1(Rule-Based Designs)\u548c\u57fa\u4e8e\u6a21\u578b\u7684\u8bbe\u8ba1(Model-Based Design)\u3002<\/span><\/p>\n


<\/p>\n

A\uff1a\u57fa\u4e8e\u89c4\u5219\u7684\u8bd5\u9a8c\u8bbe\u8ba1(Rule-Based Designs)<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5173\u952e\u70b9\uff1a\u672a\u9884\u5148\u4f30\u8ba1\u5242\u91cf-\u6bd2\u6027\u66f2\u7ebf\uff1b\u5242\u91cf\u9012\u589e\u57fa\u4e8e\u5f53\u524d\u5242\u91cf\u6c34\u5e73\u7684\u6bd2\u6027\u7ed3\u679c\uff1b\u5305\u62ec\u4f20\u7edf\u76843+3\u3001\u52a0\u901f\u6ef4\u5b9a\u3001PGDE\u8bd5\u9a8c\u7b49\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

B\uff1a\u57fa\u4e8e\u6a21\u578b\u7684\u8bbe\u8ba1(Model-Based Design)<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5173\u952e\u70b9\uff1a\u5148\u4e8e\u53d7\u8bd5\u8005\u5165\u7ec4\u524d\u5efa\u7acb\u5242\u91cf-\u6bd2\u6027\u66f2\u7ebf\u6a21\u578b\uff1b\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\uff0c\u5229\u7528\u53d7\u8bd5\u8005\u6bd2\u7406\u6570\u636e\u5b9e\u65f6\u4fee\u6b63\u5242\u91cf-\u6bd2\u6027\u66f2\u7ebf\uff1b\u8981\u6c42\u826f\u597d\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u652f\u6301\u5efa\u7acb\u548c\u4fee\u6b63\u5242\u91cf-\u6bd2\u6027\u66f2\u7ebf\uff1b\u57fa\u4e8e\u6a21\u578b\u8bbe\u8ba1\u5305\u62ec\uff1aCRM\u3001Modified CRM\u3001EWOC\u3001TITE-CRM\u3001mTPI\u3001Mixed-effect POM\u3001Fractional dose-finding\u8bd5\u9a8c\u8bbe\u8ba1\u7b49<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\"\u5e72\u8d27<\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

4<\/p>\n<\/section>\n

\n

I\u671f\u4e34\u5e8a\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u8bbe\u8ba1<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

I\u671f\u4e34\u5e8a\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u4e3b\u8981\u76ee\u7684\u662f\u8bc4\u4ef7\u836f\u7269\u6e05\u9664\u7387\u3001\u9884\u6d4b\u836f\u7269\u6216\u5176\u4ee3\u8c22\u7269\u5728\u4eba\u4f53\u53ef\u80fd\u7684\u79ef\u805a\u3001\u6f5c\u5728\u7684\u836f\u7269\u95f4\u76f8\u4e92\u4f5c\u7528\u7b49\u3002I\u671f\u4e34\u5e8a\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u4e00\u822c\u5728\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u4e4b\u540e\u8fdb\u884c\u3002<\/span><\/p>\n


<\/p>\n

4.1 \u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/strong><\/span><\/p>\n

I\u671f\u4e34\u5e8a\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u8bbe\u8ba1\u4e00\u822c\u4e3a\u968f\u673a\u4ea4\u53c9\u81ea\u8eab\u5bf9\u7167\uff0c\u4ee5\u51cf\u5c11\u4e0d\u540c\u8bd5\u9a8c\u5468\u671f\u548c\u4e2a\u4f53\u5dee\u5f02\u5bf9\u8bd5\u9a8c\u7ed3\u679c\u7684\u5f71\u54cd\u3002\u76ee\u524d\u4e3b\u8981\u6709\u4e24\u79cd\u8bd5\u9a8c\u8bbe\u8ba1\uff1a2\u5242\u91cf\u53cc\u5468\u671f\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\u30013\u5242\u91cf3\u5468\u671f3\u00d73\u62c9\u4e01\u65b9\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\u3002\u4ee5\u4e0b\u4ee53\u00d73\u62c9\u4e01\u65b9\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\u4e3a\u4f8b\u3002<\/span><\/p>\n


<\/p>\n

\u8bd5\u9a8c\u57fa\u672c\u8981\u6c42\uff1a\u53d7\u8bd5\u8005\uff1a9\u540d\u5065\u5eb7\u7537\u6027\u3002\u5206\u7ec4\uff1a\u968f\u673a\u5206\u4e3a\u4e09\u7ec4\uff0c\u6bcf\u7ec43\u4eba\u3002\u5242\u91cf\uff1a\u4f4e\u3001\u4e2d\u3001\u9ad8\u4e09\u5242\u91cf\uff1b\u9ad8\u5242\u91cf\u5fc5\u987b\u63a5\u8fd1\u6216\u7b49\u4e8eMTD\uff0c\u4e2d\u5242\u91cf\u5e94\u4e0e\u4e34\u5e8a\u62df\u5355\u6b21\u5242\u91cf\u63a5\u8fd1\u6216\u76f8\u540c\uff0c\u4e09\u4e2a\u5242\u91cf\u4e4b\u95f4\u5e94\u5448\u7b49\u6bd4\u6216\u7b49\u5dee\u5173\u7cfb\uff0c\u4ee5\u4fbf\u89c2\u5bdf\u4e0d\u540c\u5242\u91cf-\u8840\u836f\u6d53\u5ea6\u662f\u5426\u5448\u7ebf\u6027\u5173\u7cfb\u3002\u4e24\u6b21\u8bd5\u9a8c\u95f4\u9694\u5468\u671f\uff1a\u22657\u4e2a\u534a\u8870\u671f<\/span><\/p>\n


<\/p>\n

\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6848\uff1a<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\u53e6\u5916\uff0c\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u53ef\u8003\u8651\u589e\u52a0\u5982\u4e0b\u8bd5\u9a8c\uff1a<\/span><\/p>\n


<\/p>\n

\u9884\u5b9e\u9a8c\uff1a<\/span><\/strong>\u5728\u6b63\u5f0f\u8fdb\u884c\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u524d\uff0c\u53ef\u8003\u8651\u8fdb\u884c2-4\u4eba\u7684\u9884\u5b9e\u9a8c\uff0c\u4ee5\u4fbf\u53d1\u73b0\u53ef\u80fd\u51fa\u73b0\u7684\u95ee\u9898\uff0c\u5e76\u4e3a\u540e\u671f\u7684\u8bd5\u9a8c\u6761\u4ef6\u3001\u5242\u91cf\u5927\u5c0f\u3001\u89c2\u5bdf\u65f6\u95f4\u3001\u53d6\u6837\u9891\u7387\u7b49\u63d0\u4f9b\u53c2\u8003\uff0c\u4ee5\u671f\u51c6\u786e\u53cd\u5e94\u836f\u7269\u5728\u4eba\u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u8fc7\u7a0b\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u98df\u7269\u7684\u5f71\u54cd\uff1a<\/span><\/strong>\u53e3\u670d\u56fa\u4f53\u5236\u5242\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u9700\u8003\u5bdf\u9910\u524d\u3001\u9910\u540e\u836f\u52a8\u5b66\u7684\u5dee\u5f02\uff0c\u5c24\u5176\u662f\u98df\u7269\u5bf9\u836f\u7269\u5438\u6536\u7a0b\u5ea6\u7684\u5f71\u54cd\u3002<\/span><\/span><\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

5<\/p>\n<\/section>\n

\n

\u591a\u5242\u91cf\u4eba\u4f53\u8010\u53d7\u6027\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

\u5728\u5355\u5242\u91cf\u4eba\u4f53\u8010\u53d7\u6027\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u540e\uff0c\u9700\u8fdb\u884c\u591a\u6b21\u7ed9\u836f\u7684\u8010\u53d7\u6027\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\uff0c\u4ee5\u4fbf\u8003\u5bdf\u65b0\u836f\u591a\u6b21\u7ed9\u836f\u7684\u4eba\u4f53\u8010\u53d7\u6027\u4ee5\u53ca\u662f\u5426\u5b58\u5728\u836f\u7269\u84c4\u79ef\u4f5c\u7528\u7b49\u3002\u8bd5\u9a8c\u57fa\u672c\u8981\u6c42\uff1a\u53d7\u8bd5\u8005\uff1a\u4e00\u822c\u9009\u62e98-12\u540d\u5065\u5eb7\u53d7\u8bd5\u8005\u3002\u5242\u91cf\uff1a\u57fa\u4e8eII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u62df\u5b9a\u5242\u91cf\u8303\u56f4\u9009\u62e91-3\u4e2a\u5242\u91cf\u3002\u7ed9\u836f\u5468\u671f\uff1a\u57fa\u4e8e\u5355\u5242\u91cf\u836f\u4ee3\u52a8\u529b\u5b66\u4e2d\u534a\u8870\u671f\u3002<\/span><\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

6<\/p>\n<\/section>\n

\n

\u601d\u8003<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u662f\u65b0\u836f\u9996\u6b21\u5e94\u7528\u4e8e\u4eba\u4f53\uff0cI\u671f\u4e34\u5e8a\u7684\u4e3b\u8981\u76ee\u7684\u662f\u8003\u5bdf\u5065\u5eb7\u53d7\u8bd5\u8005\u5bf9\u65b0\u836f\u7684\u8010\u53d7\u6027\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u6027\u8d28\uff0c\u4e3a\u63a5\u4e0b\u6765\u5e94\u7528\u4e8e\u60a3\u8005\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u63d0\u4f9b\u6cbb\u7597\u5242\u91cf\u548c\u53ef\u80fd\u51fa\u73b0\u7684\u526f\u53cd\u5e94\u63d0\u4f9b\u53c2\u8003\u3002\u867d\u7136I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5728\u65b0\u836f\u6574\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u5468\u671f\u4e2d\u5360\u6bd4\u8f83\u5c0f\uff0c\u4f46\u6240\u8c13\u201c\u6b32\u4e8b\u4e4b\u65e0\u7e41\uff0c\u5219\u5fc5\u52b3\u4e8e\u59cb\u800c\u9038\u4e8e\u7ec8\u201d\uff0c\u4e00\u4e2a\u826f\u597d\u7684I\u671f\u4e34\u5e8a\uff0c\u80fd\u591f\u5c3d\u53ef\u80fd\u53d1\u73b0\u65b0\u836f\u7684\u7279\u6027\uff0c\u4e3a\u63a5\u4e0b\u6765\u7684II\u3001III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u63d0\u4f9b\u624e\u5b9e\u7684\u4e8b\u5b9e\u4f9d\u636e\u3002<\/span><\/p>\n


<\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

1\u30010 \u671f\u4e34\u5e8a\u8bd5\u9a8c\uff1a\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u7684\u65b0\u6a21\u5f0f<\/span><\/p>\n

2\u3001Accelerated Titration Designs for Phase I Clinical<\/span><\/p>\n

3\u3001Phase 1 Trial Design Is 3 + 3 the Best \uff1f<\/span><\/p>\n

4\u3001ICH E8.\u4e34\u5e8a\u7814\u7a76\u7684\u4e00\u822c\u8003\u8651<\/span><\/p>\n

5\u3001\u5173\u4e8e\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7814\u7a76\u7efc\u8ff0<\/span><\/p>\n

6\u3001FDA: \u4eba\u4f53\u9996\u5242\u6700\u5927\u5b89\u5168\u8d77\u59cb\u5242\u91cf\u7684\u4f30\u7b97<\/span><\/p>\n

7\u3001\u6297\u80bf\u7624\u836f\u7269\u8d1d\u53f6\u65af\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6cd5\u6bd4\u8f83\u7814\u7a76<\/span><\/p>\n

8\u3001\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a761\u671f<\/span><\/p>\n

9\u3001\u521b\u65b0\u836f\u7269I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u8bbe\u8ba1\u63a2\u8ba8<\/span><\/p>\n

10\u3001\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6cd5\u5b66<\/span><\/p>\n

11\u3001\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u4e0e\u5206\u6790<\/span><\/p>\n

12\u3001\u65b0\u836fI\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5242\u91cf\u7684\u63a2\u7d22\u4e0e\u786e\u5b9a<\/span><\/p>\n

13\u3001\u6297\u80bf\u7624\u836f\u7269\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5242\u91cf\u63a2\u7d22\u7684\u8bbe\u8ba1\u65b9\u6cd5\u6982\u8ff0<\/span><\/p>\n

\n

<\/span><\/p>\n

\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8def\u5f84\uff1aII\u671f\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/strong><\/h2>\n
\n
\n

\n
\n

1<\/p>\n<\/section>\n

\n

\u5e8f\u8a00<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

\u5728I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u660e\u786e\u4e86\u836f\u7269\u4eba\u4f53\u8010\u53d7\u6027\u3001\u5b89\u5168\u6027\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u70b9\u548c\u63a8\u8350\u7684PR2D (Recommended Phase II Dose)\uff0c\u5373\u53ef\u4ee5\u5f00\u59cb\u542f\u52a8II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u53c8\u79f0\u4e3a\u63a2\u7d22\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u662f\u65b0\u836f\u9996\u6b21\u5728\u60a3\u8005\u8eab\u4e0a\u8fdb\u884c\u3001\u4ee5\u63a2\u7d22\u6709\u6548\u6027\u4e3a\u76ee\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u7531\u4e8e\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u8d39\u7528\u9ad8\u6602\u3001\u5468\u671f\u8f83\u957f\uff0c\u4f5c\u4e3a\u627f\u4e0a\u542f\u4e0b\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u81f3\u5173\u91cd\u8981\u3002\u7533\u529e\u8005\u5e0c\u671b\u901a\u8fc7II\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u80fd\u5c3d\u5feb\u53d1\u73b0\u5f88\u6709\u524d\u666f\u7684\u65b0\u836f\u800c\u4e0d\u81f3\u4e8e\u8fc7\u65e9\u7ec8\u6b62\u7814\u7a76\uff0c\u540c\u65f6\u53c8\u5e0c\u671b\u80fd\u5c3d\u65e9\u7ec8\u6b62\u65e0\u6548\u65b0\u836f\u7684\u8fdb\u4e00\u6b65\u8bd5\u9a8c\u3002<\/span><\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

2<\/p>\n<\/section>\n

\n

II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5168\u666f\u56fe<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

I\u671f\u8bd5\u9a8c\u4fa7\u91cd\u4e8e\u65b0\u836f\u5b89\u5168\u6027\u548c\u836f\u4ee3\u52a8\u529b\u5b66\uff0c\u800cII\u671f\u8bd5\u9a8c\u91cd\u70b9\u5219\u8f6c\u79fb\u5230\u836f\u6548\u5b66\u4e0a\u3002II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u8981\u76ee\u6807\u662f\u521d\u6b65\u8003\u5bdf\u65b0\u836f\u80fd\u5426\u5728\u76ee\u6807\u60a3\u8005\u4eba\u7fa4\u4e2d\u5efa\u7acb\u836f\u6548\u5b66\u76f8\u5bf9\u6bd4\u8f83\u4e00\u81f4\u3001\u836f\u7269\u7684\u6bd2\u6027\u53ef\u4ee5\u63a5\u53d7\u7684\u6c34\u5e73\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2.1 \u662f\u4ec0\u4e48(Who)<\/span><\/strong><\/span><\/p>\n

II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u8981\u7528\u4e8e\u8bc4\u4ef7\u65b0\u836f\u5728\u76ee\u6807\u60a3\u8005\u4e0a\u7684\u521d\u6b65\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2.2 \u4e3a\u4ec0\u4e48(Why)<\/span><\/strong><\/span><\/p>\n

II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u76ee\u7684\u4e0e\u7814\u7a76\u836f\u7269\u6709\u6548\u6027\u6709\u5173\uff0c\u5176\u5bfb\u6c42\u56de\u7b54\u7684\u95ee\u9898\u5305\u62ec\uff1a\u2460\u836f\u7269\u5728I\u671f\u4e34\u5e8a\u786e\u8bc1\u7684\u5b89\u5168\u5242\u91cf\u8303\u56f4\u5185\u5bf9\u67d0\u4e00\u7279\u5b9a\u9002\u5e94\u75c7\u7684\u6709\u6548\u6027\u5982\u4f55\uff1f\u2461\u60a3\u8005\u77ed\u671f\u7684\u65b0\u836f\u4e0d\u826f\u53cd\u5e94\u548c\u98ce\u9669\u662f\u4ec0\u4e48\uff1f<\/span><\/p>\n

 <\/span><\/p>\n

2.3 \u505a\u4ec0\u4e48(What)<\/span><\/strong><\/span><\/p>\n

II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5305\u62ec\uff1a\u2460\u786e\u5b9a\u65b0\u836f\u4f5c\u7528\u4e8e\u76ee\u6807\u60a3\u8005\u7684\u6700\u5927\u548c\u6700\u5c0f\u6709\u6548\u5242\u91cf\u8303\u56f4\uff0c\u4e3aIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5242\u91cf\u63d0\u4f9b\u53c2\u8003\uff1b\u2461\u65b0\u836f\u4ea7\u751f\u7597\u6548\u7684\u8840\u836f\u6d53\u5ea6\u4e0e\u836f\u6548\u5b66\u53c2\u6570\u7684\u5173\u7cfb\uff0c\u5373\u836f\u4ee3\u52a8\u529b\u5b66\u548c\u836f\u6548\u5b66\u5173\u7cfb\u3002\u6839\u636e\u76ee\u7684\u4e0d\u540c\uff0cII\u671f\u4e34\u5e8a\u6709\u65f6\u53c8\u5206\u4e3aIIa\u671f\u548cIIb\u671f\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

2.4 \u600e\u4e48\u505a(How)<\/span><\/strong><\/p>\n

\u8bd5\u9a8c\u987a\u5e8f\uff1a<\/span><\/strong>\u4e00\u822c\u6309\u7167IIa\u671f\u3001IIb\u671f\u5e8f\u8d2f\u5b9e\u65bd\uff1b<\/span><\/span><\/p>\n

\u8bbe\u8ba1\u539f\u7406\uff1a<\/span><\/strong>II\u671f\u4f5c\u4e3a\u63a2\u7d22\u6027\u8bd5\u9a8c\uff0c\u53ef\u4ee5\u91c7\u7528\u591a\u79cd\u8bbe\u8ba1\u65b9\u6cd5\uff0c\u5982\u540c\u671f\u5bf9\u7167\u3001\u81ea\u8eab\u5bf9\u7167\u3001\u5f00\u653e\u8bd5\u9a8c\u3001\u4e09\u81c2\u8bd5\u9a8c(\u9633\u6027\u836f\u3001\u5b89\u6170\u5242\u3001\u8bd5\u9a8c\u836f)\u3001\u5242\u91cf-\u6548\u5e94\u5173\u7cfb\u7b49\u7684\u7814\u7a76\uff1b<\/span><\/span><\/p>\n

\u53d7\u8bd5\u8005\uff1a<\/span><\/strong>\u76ee\u6807\u9002\u5e94\u75c7\u60a3\u8005<\/span><\/span><\/p>\n

\u6837\u672c\u91cf\uff1a<\/span><\/strong>\u51e0\u5341\u5230\u6570\u767e\u4eba<\/span><\/span><\/p>\n

\u5224\u65ad\u7ec8\u70b9\uff1a<\/span><\/strong>\u5ba2\u89c2\u7f13\u89e3\u7387\u7b49<\/span><\/span><\/p>\n

\u63a5\u4e0b\u6765\u4ee5\u80bf\u7624\u65b0\u836f\u7684II\u671f\u4e34\u5e8a\u4e3a\u4f8b\uff0c\u4ecb\u7ecd\u5e38\u89c1II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span>
<\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

3<\/p>\n<\/section>\n

\n

\u80bf\u7624\u65b0\u836f\u7684II\u671f\u4e34\u5e8a\u8bbe\u8ba1<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6cd5\u6839\u636e\u6709\u65e0\u5bf9\u7167\u7ec4\u8bbe\u7f6e\uff0c\u5206\u4e3a\u5355\u81c2\u8bd5\u9a8c\u548c\u968f\u673a\u5bf9\u7167\u8bd5\u9a8c\u3002\u53e6\u5916\uff0c\u8fd8\u5305\u62ec\u968f\u673a\u64a4\u836f\u8bd5\u9a8c\u8bbe\u8ba1\u7b49\u3002<\/span><\/p>\n

 <\/span><\/p>\n

3.1 \u5355\u81c2\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/strong><\/span><\/p>\n

\u5355\u81c2\u7814\u7a76(Single Arm Study)\uff1a\u5373\u5355\u7ec4\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u987e\u540d\u601d\u4e49\uff0c\u5c31\u662f\u4ec5\u6709\u4e00\u4e2a\u7ec4\u7684\u7814\u7a76\uff0c\u6ca1\u6709\u4e3a\u8bd5\u9a8c\u7ec4\u8bbe\u8ba1\u76f8\u5bf9\u5e94\u7684\u5bf9\u7167\u7ec4\uff1b\u5e38\u7528\u4e8e\u65b0\u53d1\u7684\u2161a\u671f\u3002\u80bf\u7624\u65b0\u836fII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u5f80\u5f80\u8981\u5bf9\u591a\u4e2a\u7624\u79cd\u3001\u591a\u79cd\u5242\u91cf\u6216\u7528\u6cd5\u8fdb\u884c\u63a2\u8ba8\uff0c\u76ee\u7684\u662f\u6dd8\u6c70\u65e0\u6548\u5242\u91cf\u3001\u7b5b\u9009\u654f\u611f\u7624\u79cd\uff0c\u4ee5\u4fbf\u8fdb\u4e00\u6b65\u6df1\u5165\u7814\u7a76\u3002\u5355\u81c2\u8bd5\u9a8c\u53c8\u5206\u4e3a\u5355\u81c2\u5355\u9636\u6bb5\u548c\u5355\u81c2\u591a\u9636\u6bb5\uff0c\u6700\u7b80\u5355\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u5373\u4e3a\u5355\u81c2\u5355\u9636\u6bb5\u8bd5\u9a8c\uff0c\u5176\u5728\u8ba1\u5212\u7684\u6837\u672c\u6570\u91cf\u7684\u75c5\u4eba\u90fd\u63a5\u53d7\u6cbb\u7597\u540e\uff0c\u6839\u636e\u6cbb\u7597\u6548\u679c\u6700\u540e\u5f97\u51fa\u8bd5\u9a8c\u7ed3\u8bba\u3002\u5355\u81c2\u5355\u9636\u6bb5\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u7f3a\u9677\u662f\uff1a\u5982\u679c\u5728\u8fbe\u5230\u6700\u540e\u6837\u672c\u91cf\u4e4b\u524d\uff0c\u53d1\u73b0\u6cbb\u7597\u65e0\u6548\uff0c\u4e5f\u4e0d\u80fd\u7ec8\u6b62\u8bd5\u9a8c\uff0c\u9020\u6210\u8d44\u6e90\u6d6a\u8d39\u548c\u4f26\u7406\u5b66\u56f0\u5883\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5355\u81c2\u591a\u9636\u6bb5\u8bd5\u9a8c\u8bbe\u8ba1\u80fd\u591f\u907f\u514d\u5355\u9636\u6bb5\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u7f3a\u9677\uff0c\u5176\u80fd\u5728\u67d0\u8bd5\u9a8c\u7ec4\u7597\u6548\u672a\u8fbe\u5230\u9884\u671f\u6548\u679c\u65f6\uff0c\u7ec8\u6b62\u8be5\u8bd5\u9a8c\u7ec4\u7684\u7814\u7a76\uff0c\u907f\u514d\u66f4\u591a\u7684\u53d7\u8bd5\u8005\u63a5\u53d7\u65e0\u6548\u6cbb\u7597\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n


<\/span><\/p>\n

\u4e0a\u8ff0\u5355\u81c2\u591a\u9636\u6bb5\u8bd5\u9a8c\u8ba1\u7b97\u5177\u4f53\u6837\u672c\u91cf\u65f6\uff0c\u53c8\u5206\u4e3a\u6700\u4f73\u8bbe\u8ba1(optimal design)\u548c\u6781\u5927\u6781\u5c0f\u8bbe\u8ba1(min-max design)\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\u5355\u81c2\u591a\u9636\u6bb5\u8bbe\u8ba1\u4e00\u822c\u7528\u4e8e\u63a2\u7d22\u6027\u7814\u7a76\uff0c\u5176\u4f18\u70b9\u5728\u4e8e\u591a\u9636\u6bb5\u8bbe\u8ba1\u6709\u660e\u786e\u7684\u65e9\u671f\u7ec8\u6b62\u7814\u7a76\u7684\u51c6\u5219\uff0c\u5f53\u8bd5\u9a8c\u836f\u7684\u6709\u6548\u7387\u8f83\u4f4e\u65f6\uff0c\u53ef\u4ee5\u5728\u65e9\u671f\u7ec8\u6b62\u7814\u7a76\uff0c\u907f\u514d\u66f4\u591a\u7684\u53d7\u8bd5\u8005\u63a5\u53d7\u65e0\u6548\u7684\u6cbb\u7597\uff1b\u591a\u9636\u6bb5\u8bbe\u8ba1\u4e5f\u53ef\u7528\u6765\u65e9\u671f\u6dd8\u6c70\u4e0d\u826f\u53cd\u5e94\u9ad8\u7684\u836f\u7269\u3002<\/span><\/p>\n

 <\/span><\/p>\n

3.2 \u968f\u673a\u5bf9\u7167II\u671f\u4e34\u5e8a\u8bbe\u8ba1<\/span><\/strong><\/p>\n

\u7531\u4e8eII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5c5e\u4e8e\u63a2\u7d22\u6027\u4eba\u4f53\u8bd5\u9a8c\uff0c\u5176\u6837\u672c\u91cf\u5c11\uff0c\u6545\u5927\u591a\u6570II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u4e3a\u5355\u81c2\u3001\u975e\u968f\u673a\u5316\uff0c\u5e76\u4e14\u4e0d\u8bbe\u5bf9\u7167\u7ec4\uff0c\u800c\u662f\u91c7\u7528\u5386\u53f2\u6570\u636e\u5bf9\u7167\uff0c\u8fd9\u589e\u52a0\u4e86\u5bf9\u65b0\u836f\u6709\u6548\u6027\u5224\u65ad\u7684\u4e0d\u786e\u5b9a\u6027\u3002\u4e3a\u4e86\u964d\u4f4eIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5931\u8d25\u7684\u98ce\u9669\uff0c\u4f5c\u4e3a\u524d\u77bb\u54e8\u6240\u7684II\u671f\u4e34\u5e8a\u9f13\u52b1\u91c7\u7528\u968f\u673a\u5bf9\u7167\u8bbe\u8ba1\uff0c\u5e76\u4e14\u4fdd\u8bc1\u6837\u672c\u91cf\u5177\u6709\u4e00\u5b9a\u7edf\u8ba1\u5b66\u4f30\u7b97\u57fa\u7840\u3002\u5c3d\u7ba1II\u671f\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bbe\u8ba1\u6ca1\u6709\u8db3\u591f\u7684\u7edf\u8ba1\u628a\u63e1\u5ea6\u5bf9\u65b0\u836f\u548c\u6807\u51c6\u6cbb\u7597\u95f4\u505a\u51fa\u51b3\u5b9a\u6027\u7684\u8bc4\u4ef7\uff0c\u4f46\u8fd9\u79cd\u8bbe\u8ba1\u53ef\u4ee5\u4e3a\u6709\u524d\u666f\u7684\u65b0\u836f\u4f18\u5148\u8fdb\u5165III\u671f\u8bd5\u9a8c\u63d0\u4f9b\u91cf\u5316\u4f9d\u636e\u3002II\u671f\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u53ef\u5e94\u7528\u4e8e\u8bc4\u4ef7\uff1a\u591a\u79cd\u5242\u91cf\u3001\u591a\u79cd\u7ed9\u836f\u65b9\u6848\u3001\u8bd5\u9a8c\u6cbb\u7597\u548c\u6807\u51c6\u6cbb\u7597\u5bf9\u6bd4\u7684\u7814\u7a76\uff0c\u4e3aIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u63d0\u4f9b\u66f4\u52a0\u5177\u6709\u501f\u9274\u610f\u4e49\u7684\u6570\u636e\u3002II\u671f\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u4e00\u822c\u6d41\u7a0b\u5982\u4e0b\u56fe\u6240\u793a\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

II\u671f\u968f\u673a\u5316\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u8981\u76ee\u7684\u662f\u901a\u8fc7\u5bf9\u6240\u8bd5\u9a8c\u836f\u7269\u7684\u6709\u6548\u7387\u8fdb\u884c\u8bc4\u4f30\uff0c\u4ece\u800c\u9009\u62e9\u6709\u6548\u7387\u6700\u4f73\u7684\u5242\u91cf\u3001\u7ed9\u836f\u65b9\u6848\u6216\u5019\u9009\u836f\u7269\u8fdb\u5165III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002II\u671f\u968f\u673a\u5316\u4e34\u5e8a\u8bd5\u9a8c\u6240\u9700\u7684\u6837\u672c\u91cf\u4e0d\u8db3\u4ee5\u5bf9\u8bd5\u9a8c\u836f\u63d0\u4f9b\u660e\u786e\u7684\u4f18\u6548\u6027\u3001\u975e\u52a3\u6548\u6027\u6216\u7b49\u6548\u6027\u8fdb\u884c\u63a8\u65ad\u3002<\/span><\/p>\n

 <\/span><\/p>\n

3.3 \u968f\u673a\u64a4\u836f\u8bbe\u8ba1<\/span><\/strong><\/p>\n

\u968f\u673a\u64a4\u7a76\u662f\u6307\u901a\u8fc7\u63a5\u53d7\u4e00\u5b9a\u65f6\u95f4\u53d7\u8bd5\u836f\u7269\u6cbb\u7597\u7684\u5bf9\u8c61\u51fa\u73b0\u75be\u75c5\u7a33\u5b9a\u6027\u72b6\u6001\u540e\uff0c\u88ab\u968f\u673a\u5206\u914d\u7ee7\u7eed\u4f7f\u7528\u53d7\u8bd5\u836f\u7269\u6cbb\u7597\u6216\u4f7f\u7528\u5b89\u6170\u5242(\u5373\u505c\u7528\u6d3b\u6027\u836f\u7269)\u6cbb\u7597\uff1b\u7ee7\u7eed\u63a5\u53d7\u836f\u7269\u6cbb\u7597\u7ec4\u548c\u5b89\u6170\u5242\u7ec4\u4e4b\u95f4\u51fa\u73b0\u7684\u4efb\u4f55\u5dee\u5f02\u90fd\u53ef\u4ee5\u8bc1\u660e\u6d3b\u6027\u836f\u7269\u7684\u7597\u6548\u3002\u968f\u673a\u64a4\u836f\u8bbe\u8ba1\u7684\u4f18\u70b9\u662f\uff1a\u75c5\u4eba\u7ecf\u8fc7\u5b89\u6170\u5242\u4f7f\u7528\u9636\u6bb5\u6bd4\u8f83\u77ed\uff0c\u4f26\u7406\u5b66\u98ce\u9669\u88ab\u5927\u5927\u964d\u4f4e\u3002\u968f\u673a\u64a4\u836f\u65b9\u6cd5\u9002\u5408\u4e8e\u590d\u53d1\u6027\u75be\u75c5\u53d1\u4f5c\u7684\u836f\u7269(\u4f8b\u5982\u6297\u6291\u90c1\u836f)\uff0c\u6291\u5236\u75c7\u72b6\u6216\u4f53\u5f81(\u6162\u6027\u75bc\u75db\u3001\u9ad8\u8840\u538b\u3001\u5fc3\u7ede\u75db)\u7684\u836f\u7269\u4e34\u5e8a\u5bf9\u7167\u8bd5\u9a8c\u7b49\u3002<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

4<\/p>\n<\/section>\n

\n

\u601d\u8003<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u822c\u662f\u65b0\u836f\u9996\u6b21\u5e94\u7528\u4e8e\u76ee\u6807\u60a3\u8005\uff0c\u4ee5\u89c2\u5bdf\u65b0\u836f\u7684\u521d\u6b65\u6709\u6548\u6027\u3001\u5b89\u5168\u6027\u6570\u636e\u3002\u7531\u4e8eIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u822c\u4e3a\u5927\u89c4\u6a21\u786e\u8bc1\u6027\u8bd5\u9a8c\uff0c\u5176\u5e38\u5e38\u4e3a\u591a\u4e2d\u5fc3\u3001\u5927\u6837\u672c\u3001\u957f\u5468\u671f\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u662fFDA\u8bc4\u4ef7\u3001\u6279\u51c6\u65b0\u836f\u6700\u5173\u952e\u7684\u8bc1\u636e\uff0c\u800c\u4f5c\u4e3a\u5148\u5934\u90e8\u961f\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5bf9III\u671f\u5177\u6709\u91cd\u5927\u610f\u4e49\u3002\u5408\u7406\u79d1\u5b66\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u4e0d\u4ec5\u80fd\u591f\u5728\u65e9\u671f\u8fa8\u6790\u65b0\u836f\u8fdb\u4e00\u6b65\u5f00\u53d1\u7684\u4ef7\u503c\uff0c\u540c\u65f6\u8fd8\u80fd\u591f\u4e3aIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u63a8\u8350\u5408\u7406\u7684\u4e34\u5e8a\u5b9a\u4f4d\u3001\u62df\u7528\u4e8e\u6cbb\u7597\u9002\u5e94\u75c7\u3001\u9002\u5b9c\u7684\u7eb3\u5165\u75be\u75c5\u4eba\u7fa4\u7684\u9009\u62e9\u3001\u4e3b\u8981\u7597\u6548\u6307\u6807\u3001\u5b89\u5168\u6027\u6307\u6807\u3001\u7ed9\u836f\u5242\u91cf\u3001\u7ed9\u836f\u65b9\u6cd5\u3001\u7597\u7a0b\u7b49\uff0c\u53ef\u8c13\u8d23\u4efb\u91cd\u5927\u3002\u8fdf\u53d1\u6027\u6bd2\u6027\u662fII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u95ee\u9898\u4e4b\u4e00\uff0c\u5efa\u8baeII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u610f\u540c\u65f6\u68c0\u6d4b\u53cd\u5e94\u548c\u6bd2\u6027\u53d8\u91cf\u3002\u53e6\u5916\uff0c\u5b64\u513f\u836f\u6216\u6709\u91cd\u5927\u7a81\u7834\u6027\u7597\u6cd5\u65b0\u836f\u5728\u5b8c\u6210II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u540e\uff0c\u7533\u529e\u8005\u53ef\u5411FDA\u7533\u8bf7\u4e0a\u5e02\uff0cFDA\u5728\u8bc4\u4f30\u60a3\u8005\u5229\u76ca\/\u98ce\u9669\u6bd4\u540e\uff0c\u53ef\u201c\u6709\u6761\u4ef6\u6279\u51c6\u201d\u8be5\u7c7b\u65b0\u836f\u57fa\u4e8e\u4e34\u5e8aII\u671f\u6570\u636e\u63d0\u524d\u4e0a\u5e02\u9500\u552e\uff1b\u5728\u65b0\u836f\u4e0a\u5e02\u9500\u552e\u671f\u95f4\uff0c\u7533\u62a5\u8005\u4ecd\u9700\u7ee7\u7eed\u8fdb\u884c\u4e34\u5e8aIII\u671f\u8bd5\u9a8c\uff0c\u4ee5\u4fbf\u4ea7\u54c1\u6700\u7ec8\u83b7\u6279\u3002\u6b63\u6240\u8c13\u201c\u79e4\u7823\u867d\u5c0f\u538b\u5343\u65a4\u201d\uff0cII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5728\u6574\u4e2a\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u8d77\u5230\u627f\u4e0a\u542f\u4e0b\u7684\u4f5c\u7528\u3002<\/span><\/p>\n


<\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

1.\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u4e0e\u5206\u6790<\/span><\/p>\n

2.\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6cd5\u5b66<\/span><\/p>\n

3.\u80bf\u7624\u65b0\u836f\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u591a\u9636\u6bb5\u8bbe\u8ba1<\/span><\/p>\n

4.\u6297\u80bf\u7624\u836f\u7269\u2161\u671f\u4e34\u5e8a\u7814\u7a76\u8bbe\u8ba1\u8003\u8651\u8981\u70b9<\/span><\/p>\n

5.\u4e2d\u836f\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u4e00\u822c\u539f\u5219<\/span><\/p>\n

6.\u6297\u80bf\u7624\u836f\u7269\u7684ii\u671f\u4e34\u5e8a\u8bd5\u9a8c–\u9776\u5411\u6cbb\u7597\u65f6\u4ee3\u7684\u5e38\u89c4\u8bbe\u8ba1\u548c\u65b0\u7b56\u7565\u4ecb\u7ecd<\/span><\/p>\n

\n

<\/span>
<\/p>\n

\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8def\u5f84\uff1aIII\u671f\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/strong><\/h2>\n
\n
\n

\n
\n

1<\/p>\n<\/section>\n

\n

\u5e8f\u8a00<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u662f\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u9636\u6bb5\u7684\u5173\u952e\u6027\u8bd5\u9a8c\uff0c\u662f\u65b0\u836f\u80fd\u5426\u6700\u7ec8\u83b7\u6279\u4e0a\u5e02\u7684\u4e34\u5e8a\u57fa\u7840\u3002III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u53c8\u79f0\u4e3a\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5176\u662f\u4e3a\u4e86\u8fdb\u4e00\u6b65\u786e\u8bc1II\u671f\u4e34\u5e8a\u8bd5\u9a8c(\u63a2\u7d22\u6027\u4e34\u5e8a\u8bd5\u9a8c)\u6240\u5f97\u5230\u6709\u5173\u65b0\u836f\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u6570\u636e\uff0c\u4e3a\u65b0\u836f\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u63d0\u4f9b\u8db3\u591f\u7684\u8bc1\u636e\u3002III\u671f\u4e34\u5e8a\u7814\u7a76\u4e00\u822c\u662f\u5173\u4e8e\u66f4\u5e7f\u6cdb\u4eba\u7fa4\u3001\u75be\u75c5\u7684\u4e0d\u540c\u9636\u6bb5\uff0c\u6216\u5408\u5e76\u7528\u836f\u7684\u7814\u7a76\u3002\u53e6\u5916\uff0c\u5bf9\u4e8e\u9884\u8ba1\u957f\u671f\u670d\u7528\u7684\u836f\u7269\uff0cIII\u671f\u4e34\u5e8a\u7814\u7a76\u4f1a\u8fdb\u884c\u836f\u7269\u5ef6\u65f6\u66b4\u9732\u7684\u8bd5\u9a8c\u3002<\/span><\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

2<\/p>\n<\/section>\n

\n

III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5168\u666f<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

2.1 \u662f\u4ec0\u4e48(Who)<\/span><\/strong><\/span><\/p>\n

III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5c5e\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6cbb\u7597\u4f5c\u7528\u786e\u8bc1\u9636\u6bb5\uff0c\u901a\u8fc7III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bc1\u660e\u65b0\u836f\u5bf9\u76ee\u6807\u9002\u5e94\u75c7\u60a3\u8005\u662f\u5b89\u5168\u6709\u6548\u7684\uff0c\u5176\u53d7\u76ca\/\u98ce\u9669\u6bd4\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\uff0c\u4e3a\u836f\u7269\u7533\u62a5\u6ce8\u518c\u63d0\u4f9b\u5145\u5206\u7684\u4f9d\u636e\uff0c\u540c\u65f6\u8fd8\u4e3a\u836f\u54c1\u8bf4\u660e\u4e66\u548c\u533b\u751f\u5904\u65b9\u63d0\u4f9b\u5145\u5206\u7684\u6570\u636e\u3002<\/span><\/p>\n


<\/span><\/p>\n

2.2 \u4e3a\u4ec0\u4e48(Why)<\/span><\/strong><\/span>
<\/p>\n

II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u53d7\u8bd5\u8005\u7684\u6837\u672c\u91cf\u8f83\u5c11\uff0c\u5176\u83b7\u5f97\u65b0\u836f\u5173\u4e8e\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u6570\u636e\u4e0d\u8db3\u4ee5\u652f\u6301\u65b0\u836f\u83b7\u5f97\u4e0a\u5e02\u6279\u51c6\u3002\u800cIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u4ee5\u901a\u8fc7\u8db3\u591f\u591a\u7684\u53d7\u8bd5\u6837\u672c\u91cf\uff0c\u8fdb\u4e00\u6b65\u786e\u8bc1II\u671f\u4e34\u5e8a\u5173\u4e8e\u65b0\u836f\u7684\u7597\u6548\u3001\u957f\u671f\u5b89\u5168\u6027\u548c\u53d7\u76ca\/\u98ce\u9669\u6bd4\uff0c\u4e3a\u65b0\u836f\u6700\u7ec8\u83b7\u6279\u4e0a\u5e02\u63d0\u4f9b\u786e\u5207\u7684\u8bc1\u636e\u3002<\/span><\/p>\n


<\/span><\/strong><\/p>\n

2.3 \u505a\u4ec0\u4e48(What)<\/span><\/strong><\/span>
<\/p>\n

III\u671f\u4e34\u5e8a\u4e3b\u8981\u7528\u6765\u56de\u7b54\u4e00\u4e2a\u95ee\u9898\uff1a\u65b0\u836f\u7684\u53d7\u76ca\/\u98ce\u9669\u6bd4\u5982\u4f55\uff1f\u4e3a\u56de\u7b54\u8be5\u95ee\u9898\uff0cIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u822c\u662f\u5177\u6709\u8db3\u591f\u53d7\u8bd5\u8005\u6837\u672c\u91cf\u7684\u968f\u673a\u76f2\u6cd5\u5bf9\u7167\u8bd5\u9a8c\u3002III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e5f\u53ef\u4ee5\u8fdb\u884c\u91cf-\u6548\u5173\u7cfb\u7684\u7814\u7a76\uff0c\u540c\u65f6\u4e5f\u53ef\u4ee5\u6839\u636e\u836f\u7269\u7279\u70b9\u3001\u76ee\u6807\u60a3\u8005\u7684\u5177\u4f53\u60c5\u51b5\uff0c\u8fdb\u884c\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u7b49\u7684\u7814\u7a76\u3002III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u65f6\u9700\u63d0\u4f9b\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u7ed3\u8bba\uff0c\u5305\u62ec\uff1a\u65b0\u836f\u76ee\u6807\u9002\u5e94\u75c7\u3001\u6240\u7eb3\u5165\u7684\u75be\u75c5\u4eba\u7fa4\u3001\u4e3b\u8981\u7597\u6548\u6307\u6807\u3001\u7ed9\u836f\u9014\u5f84\u3001\u7528\u6cd5\u7528\u91cf\u53ca\u7597\u7a0b\u3001\u8db3\u591f\u652f\u6301\u6ce8\u518c\u7533\u8bf7\u7684\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u5e76\u9488\u5bf9\u6709\u6548\u6027\u5b89\u5168\u6027\u6570\u636e\u8fdb\u884c\u5168\u9762\u7684\u98ce\u9669\/\u6548\u76ca\u7684\u8bc4\u4f30\u7b49\u3002\u53e6\u5916\uff0c\u6839\u636e\u4e0d\u540c\u9002\u5e94\u75c7\u6216\u8054\u5408\u7528\u836f\uff0c\u7533\u529e\u8005\u4f1a\u5c06III\u671f\u4e34\u5e8a\u8fdb\u4e00\u6b65\u7ec6\u5206\u4e3aIIIa\u548cIIIb\u671f\uff0c\u7533\u62a5\u8005\u5b8c\u6210IIIa\u4e34\u5e8a\u8bd5\u9a8c\u540e\u5373\u53ef\u7533\u8bf7\u4e0a\u5e02\u6279\u51c6\uff0c\u8fd9\u6837\u4e00\u822c\u53ef\u4ee5\u52a0\u5feb\u4e0a\u5e02\u8fdb\u5ea6\uff0c\u63d0\u9ad8\u5e02\u573a\u6536\u76ca\uff1b\u800c\u901a\u8fc7IIIb\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u4ee5\u8fdb\u4e00\u6b65\u6269\u5c55\u65b0\u836f\u9002\u5e94\u75c7\uff0c\u52a0\u5927\u5e02\u573a\u6536\u5165\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

2.4 \u600e\u4e48\u505a(How)<\/span><\/strong><\/p>\n

\u8bd5\u9a8c\u539f\u7406\uff1a<\/span><\/strong>\u4e00\u822c\u901a\u8fc7\u65b0\u836f\u4e0e\u73b0\u6709\u6807\u51c6\u6cbb\u7597\u7684\u6bd4\u8f83\uff0cIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5206\u4e3a\u4f18\u6548\u6027\u8bd5\u9a8c\u548c\u975e\u52a3\u6548\u6027\u8bd5\u9a8c\u3002\u8bd5\u9a8c\u8fc7\u7a0b\u5e38\u91c7\u7528\u968f\u673a\u76f2\u6cd5\u3001\u9633\u6027\u5bf9\u7167\u8bd5\u9a8c\uff1b\u65e0\u5e02\u552e\u9633\u6027\u836f\u7269\u65f6\uff0c\u53ef\u9009\u7528\u5b89\u6170\u5242\u8fdb\u884c\u5bf9\u7167\u3002<\/span><\/span><\/p>\n

\u53d7\u8bd5\u8005\uff1a<\/span><\/strong>\u76ee\u6807\u9002\u5e94\u75c7\u60a3\u8005\uff1b<\/span><\/span><\/p>\n

\u6837\u672c\u91cf\uff1a<\/span><\/strong>\u4e00\u822c\u4e3a\u6570\u767e\u81f3\u6570\u5343\u4eba\uff1b<\/span><\/span><\/p>\n

\u63a5\u4e0b\u6765\u4e3b\u8981\u4ecb\u7ecd\u5e38\u89c1\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span><\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

3<\/p>\n<\/section>\n

\n

III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u822c\u91c7\u7528\u968f\u673a\u3001\u5e73\u884c\u5bf9\u7167\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u786e\u8bc1\u65b0\u836f\u5728\u7279\u5b9a\u76ee\u6807\u4eba\u7fa4\u4e2d\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u5728\u5177\u4f53\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6848\u4e2d\uff0c\u8bd5\u9a8c\u8bbe\u8ba1\u7c7b\u578b\u7684\u9009\u62e9\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u8fd9\u51b3\u5b9a\u4e86\u6837\u672c\u91cf\u7684\u4f30\u8ba1\u3001\u7814\u7a76\u8fc7\u7a0b\u53ca\u5176\u8d28\u91cf\u63a7\u5236\u3002\u56e0\u6b64\uff0c\u7814\u7a76\u8005\u5e94\u6839\u636e\u8bd5\u9a8c\u76ee\u7684\u548c\u8bd5\u9a8c\u6761\u4ef6\u7684\u4e0d\u540c\uff0c\u9009\u62e9\u4e0d\u540c\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6848\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\"\u5e72\u8d27<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

\"\u5e72\u8d27<\/p>\n

\"\u5e72\u8d27<\/p>\n

<\/span><\/p>\n

\n
\n

\n
\n

4<\/p>\n<\/section>\n

\n

\u542f\u793a<\/strong><\/p>\n<\/section>\n<\/h2>\n<\/section>\n<\/section>\n

\u4e00\u4e2a\u65b0\u836f\u7ecf\u8fc7\u9996\u6b21\u6570\u5341\u4eba\u5065\u5eb7\u53d7\u8bd5\u8005\u7684\u4eba\u4f53\u8bd5\u9a8c(First In Human\uff0cFIH)\uff0c\u4e00\u76f4\u52305\u30016\u5e74\u540e\u6210\u5343\u4e0a\u767e\u76ee\u6807\u60a3\u8005\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u65b0\u836f\u5386\u5c3d\u78e8\u96be\uff0c\u53ef\u8c13\u4e5d\u6b7b\u4e00\u751f\u3002\u6574\u4e2a\u8fc7\u7a0b\u5386\u7ecf\u4eba\u4f53\u8010\u53d7\u6027\u8bd5\u9a8c\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u3001\u521d\u6b65\u836f\u6548\u5b66\u8bd5\u9a8c\u3001\u5927\u89c4\u6a21\u786e\u8bc1\u6027\u8bd5\u9a8c\uff1b\u5176\u4e2d\u53ef\u80fd\u8fd8\u5305\u62ec\u7279\u5b9a\u4eba\u7fa4\u7684\u8003\u5bdf(\u8001\u4eba\u3001\u513f\u7ae5\u3001\u529f\u80fd\u7f3a\u9677\u7b49)\u3001\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u7684\u8003\u5bdf\u7b49\u7b49\u3002\u4e34\u5e8a\u8bd5\u9a8c\u662f\u65b0\u836f\u662f\u5426\u6279\u51c6\u4e0a\u5e02\u7684\u51b3\u5b9a\u6027\u9636\u6bb5\uff0c\u4efb\u4f55\u4e00\u4e2a\u73af\u8282\u51fa\u73b0\u95ee\u9898\uff0c\u5bf9\u4e8e\u5236\u836f\u516c\u53f8\uff0c\u5c24\u5176\u662f\u521d\u521b\u516c\u53f8\u6253\u51fb\u662f\u5de8\u5927\u751a\u81f3\u6bc1\u706d\u6027\u7684\u3002\u540c\u65f6\uff0c\u4e34\u5e8a\u7814\u7a76\u8d39\u7528\u53c8\u662f\u6602\u8d35\u7684\uff0c\u7ea6\u5360\u6574\u4e2a\u65b0\u53d1\u603b\u8d39\u7528\u7684\u4e09\u5206\u4e4b\u4e8c\uff0c\u9ad8\u8fbe\u6570\u4ebf\u7f8e\u91d1\u3002\u6b63\u662f\u7531\u4e8e\u4e34\u5e8a\u7814\u7a76\u7684\u91cd\u8981\u6027\u548c\u6210\u672c\u9ad8\u6602\uff0c2007\u5e74FDA\u53d1\u5e03\u4e86\u300aTarget Product Profile \u2014 A Strategic Development Process Tool\u300b\uff0c\u5373\u57fa\u4e8e\u76ee\u6807\u4ea7\u54c1\u7279\u5f81(TPP)\u7684\u4ea7\u54c1\u5f00\u53d1\u7b56\u7565\u3002TPP\u662f\u4e00\u79cd\u59cb\u4e8e\u5934\u8111\u7684\u6982\u5ff5\uff0c\u5373\u9996\u5148\u662f\u7533\u529e\u8005\u57fa\u4e8e\u836f\u7269\u524d\u671f\u7814\u7a76\uff0c\u901a\u8fc7\u8bbe\u5b9a\u672a\u6765\u4ea7\u54c1\u7684\u6807\u7b7e\u6765\u5b9a\u4e49\u65b0\u836f\u5f00\u53d1\u76ee\u6807\uff0c\u5236\u5b9a\u65e8\u5728\u652f\u6301\u4ea7\u54c1\u6807\u7b7e(label)\u7684\u5177\u4f53\u4e34\u5e8a\u8bd5\u9a8c\uff1b\u4ee5TPP\u4e3a\u4e3b\u7ebf\u548c\u76ee\u6807\u6765\u5168\u7a0b\u3001\u6709\u6548\u5730\u6307\u5bfc\u548c\u89c4\u5212\u521b\u65b0\u836f\u4e34\u5e8a\u5f00\u53d1\u548c\u7814\u7a76\uff0c\u63d0\u9ad8\u7533\u529e\u8005\u4e0e\u7ba1\u7406\u5f53\u5c40\u5728\u4e34\u5e8a\u5f00\u53d1\u7684\u5404\u9636\u6bb5(\u5c24\u5176\u662f\u6280\u672f\u5ba1\u8bc4\u548c\u4f1a\u8bae)\u4ea4\u6d41\u8fc7\u7a0b\u4e2d\u6548\u7387\uff0c\u6700\u7ec8\u63d0\u5347\u65b0\u836f\u4e34\u5e8a\u5f00\u53d1\u6548\u7387\u3002<\/span><\/p>\n


<\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

1\u3001New approaches to clinical trials: Adaptive designs<\/span><\/p>\n

2\u3001\u7f8e\u56fd\u6297\u80bf\u7624\u836f\u7269III\u671f\u4e34\u5e8a\u8bbe\u8ba1\u548c\u8bc4\u4ef7\u4ecb\u7ecd<\/span><\/p>\n

3\u3001Target Product Profile \u2014 A Strategic Development Process Tool<\/span><\/p>\n

4\u3001\u7f8e\u56fdFDA \u201c\u76ee\u6807\u4ea7\u54c1\u7279\u6027(TPP)\u6307\u5bfc\u539f\u5219(\u8349\u6848)\u201d\u4ecb\u7ecd<\/span><\/p>\n

5\u3001ICH E8<\/span><\/p>\n

6\u3001\u4e2d\u836f\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u4e00\u822c\u539f\u5219<\/span><\/p>\n

7\u3001\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6cd5\u5b66<\/span><\/p>\n

8\u3001\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u4e0e\u5206\u6790<\/span><\/p>\n

9\u3001\u4e34\u5e8a\u8bd5\u9a8c-\u65b9\u6cd5\u5b66\u63a2\u7a76<\/span><\/p>\n

10\u3001\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e00\u822c\u8003\u8651\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u60f3\u6bcf\u5929\u6536\u5230\u7c7b\u4f3c\u6d88\u606f\uff0c\u5c31\u7f6e\u9876\u201c\u201d\u548c\u5206\u4eab\u5230\u670b\u53cb\u5708\u5427\uff01 \u6587\u7ae0\u6765\u6e90\uff1a\u3001 \u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8def\u5f84\uff1aI\u671f\u4e34\u5e8a\u8bd5\u9a8c 1 \u80cc\u666f\u77e5 […]<\/p>\n","protected":false},"author":1,"featured_media":57906,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57905"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=57905"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57905\/revisions"}],"predecessor-version":[{"id":57927,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57905\/revisions\/57927"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/57906"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=57905"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=57905"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=57905"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}