{"id":3942,"date":"2026-01-14T12:14:34","date_gmt":"2026-01-14T03:14:34","guid":{"rendered":"https:\/\/chiken-japan.co.jp\/blog\/?p=3942"},"modified":"2026-01-14T12:14:35","modified_gmt":"2026-01-14T03:14:35","slug":"clinical-trial-design","status":"publish","type":"post","link":"https:\/\/chiken-japan.co.jp\/blog\/clinical-trial-design\/","title":{"rendered":"\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306e\u6559\u79d1\u66f8\uff5c\u57fa\u790e\u30fb\u7a2e\u985e\u304b\u3089\u30d0\u30b9\u30b1\u30c3\u30c8\u30fb\u30d9\u30a4\u30ba\u6d41\u30fbPMDA\u6307\u91dd\u307e\u3067\u5b8c\u5168\u89e3\u8aac"},"content":{"rendered":"\n

\u300c\u3069\u306e\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u304c\u81ea\u5206\u305f\u3061\u306e\u7814\u7a76\u306b\u6700\u9069\u304b\u308f\u304b\u3089\u306a\u3044\u300d\u3002<\/p>\n\n\n\n

\u591a\u304f\u306e\u533b\u7642\u5f93\u4e8b\u8005\u3084\u958b\u767a\u62c5\u5f53\u8005\u304c\u3001\u3053\u306e\u58c1\u306b\u76f4\u9762\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u9069\u5207\u306a\u30c7\u30b6\u30a4\u30f3\u306a\u3057\u306b\u3001\u4fe1\u983c\u3067\u304d\u308b\u30c7\u30fc\u30bf\u306f\u751f\u307e\u308c\u307e\u305b\u3093\u3002<\/p>\n\n\n\n

\u672c\u8a18\u4e8b\u3067\u306f\u3001\u30e9\u30f3\u30c0\u30e0\u5316\u6bd4\u8f03\u8a66\u9a13\uff08RCT\uff1a\u53c2\u52a0\u8005\u3092\u30e9\u30f3\u30c0\u30e0\u306b\u5272\u308a\u4ed8\u3051\u3066\u6cbb\u7642\u52b9\u679c\u3092\u6bd4\u8f03\u3059\u308b\u8a66\u9a13\uff09\u306a\u3069\u306e\u57fa\u790e\u304b\u3089\u3001\u8fd1\u5e74\u6ce8\u76ee\u3055\u308c\u308b\u30d0\u30b9\u30b1\u30c3\u30c8\u8a66\u9a13\u30fb\u30a2\u30c0\u30d7\u30c6\u30a3\u30d6\u30c7\u30b6\u30a4\u30f3\u30fb\u30d9\u30a4\u30ba\u6d41<\/strong>\u3068\u3044\u3063\u305f\u9769\u65b0\u7684\u624b\u6cd5\uff08CID\uff1a\u5f93\u6765\u578b\u3092\u8d85\u3048\u305f\u8907\u96d1\u3067\u65b0\u3057\u3044\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\uff09\u307e\u3067\u3092\u4f53\u7cfb\u7684\u306b\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb(PMDA)\u306e\u300c\u81e8\u5e8a\u8a66\u9a13\u306e\u4e00\u822c\u6307\u91dd\u300d\u306b\u57fa\u3065\u304d\u3001\u79d1\u5b66\u7684\u59a5\u5f53\u6027\u3068\u502b\u7406\u6027\u3092\u4e21\u7acb\u3059\u308b\u305f\u3081\u306e\u77e5\u8b58\u3092\u7db2\u7f85\u3057\u307e\u3057\u305f\u3002<\/p>\n\n\n\n

\u6cbb\u9a13\u306b\u95a2\u308f\u308b\u5168\u3066\u306e\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30eb\u306e\u305f\u3081\u306e\u300c\u6301\u3061\u904b\u3079\u308b\u6559\u79d1\u66f8\u300d\u3068\u3057\u3066\u6d3b\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n

\u81e8\u5e8a\u7814\u7a76\u306e\u5b9f\u65bd\u5148\u3092\u304a\u63a2\u3057\u306e\u4f01\u696d\u69d8\u3078<\/div>
\n
\"\"<\/figure>\n\n\n\n

\u5f0a\u793e\u306f\u533b\u7642\u306e\u672a\u6765\u3092\u652f\u3048\u308b\u81e8\u5e8a\u7814\u7a76\u306e\u652f\u63f4\u3092\u901a\u3058\u3001\u793e\u4f1a\u306b\u8ca2\u732e\u3059\u308b\u3053\u3068\u3092\u7406\u5ff5\u3068\u3057\u3066\u63b2\u3052\u3066\u304a\u308a\u307e\u3059\u3002
\u3054\u76f8\u8ac7\u3044\u305f\u3060\u304f\u7814\u7a76\u5185\u5bb9\u3084\u6761\u4ef6\u306b\u5fdc\u3058\u3066\u3001\u67d4\u8edf\u304b\u3064\u8aa0\u5b9f\u306b\u5bfe\u5fdc\u3055\u305b\u3066\u3044\u305f\u3060\u304d\u307e\u3059\u3002
\u81e8\u5e8a\u7814\u7a76\u306e\u5b9f\u65bd\u306b\u3042\u305f\u308a\u3054\u652f\u63f4\u304c\u5fc5\u8981\u306a\u5834\u5408\u306f\u3001\u305c\u3072\u304a\u6c17\u8efd\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n

\n
\u304a\u554f\u3044\u5408\u308f\u305b\u306f\u3053\u3061\u3089\u304b\u3089<\/strong><\/span><\/a><\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n

\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3068\u306f\uff1f \u76ee\u7684\u3068\u300c3\u3064\u306e\u57fa\u672c\u8981\u7d20\u300d<\/strong><\/h2>\n\n\n\n

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

\u306a\u305c\u300c\u30c7\u30b6\u30a4\u30f3\u300d\u304c\u6700\u91cd\u8981\u306a\u306e\u304b<\/strong><\/h3>\n\n\n\n

\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30b6\u30a4\u30f3\u306f\u3001\u5efa\u7269\u306e\u300c\u8a2d\u8a08\u56f3\u300d\u306b\u76f8\u5f53\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

 \u6700\u3082\u91cd\u8981\u306a\u5f79\u5272\u306f\u30a8\u30d3\u30c7\u30f3\u30b9\u30ec\u30d9\u30eb\u306e\u62c5\u4fdd<\/strong>\u3067\u3059\uff08\u30a8\u30d3\u30c7\u30f3\u30b9\u30ec\u30d9\u30eb\uff1a\u7814\u7a76\u7d50\u679c\u306e\u4fe1\u983c\u6027\u306e\u5f37\u3055\u3092\u793a\u3059\u6982\u5ff5\uff09\u3002<\/p>\n\n\n\n

\u4e0d\u9069\u5207\u306a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3067\u53ce\u96c6\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306f\u3001\u3069\u308c\u307b\u3069\u9ad8\u5ea6\u306a\u7d71\u8a08\u89e3\u6790\u3092\u884c\u3063\u3066\u3082\u4fe1\u983c\u3067\u304d\u308b\u7d50\u8ad6\u3092\u5c0e\u304d\u51fa\u305b\u307e\u305b\u3093\uff08GIGO: Garbage In, Garbage Out\uff1a\u5165\u529b\u30c7\u30fc\u30bf\u306e\u8cea\u304c\u60aa\u3051\u308c\u3070\u7d50\u679c\u3082\u60aa\u304f\u306a\u308b\u3068\u3044\u3046\u8003\u3048\u65b9\uff09\u3002<\/p>\n\n\n\n

PMDA\u306e\u300c\u81e8\u5e8a\u8a66\u9a13\u306e\u4e00\u822c\u6307\u91dd\u300d\u306b\u304a\u3044\u3066\u3082\u3001\u300c2.2 \u79d1\u5b66\u7684\u306a\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u3068\u89e3\u6790\u300d\u3068\u3057\u3066\u3001\u30d0\u30a4\u30a2\u30b9\u3092\u6392\u9664\u3057\u3001\u4e8b\u524d\u306b\u8a08\u753b\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3046\u3053\u3068\u306e\u91cd\u8981\u6027\u304c\u5f37\u8abf\u3055\u308c\u3066\u3044\u307e\u3059\uff08\u30d0\u30a4\u30a2\u30b9\uff1a\u7d50\u679c\u3092\u6b6a\u3081\u308b\u7cfb\u7d71\u7684\u306a\u504f\u308a\uff09\u3002<\/p>\n\n\n\n

 \u307e\u305f\u3001\u30c7\u30b6\u30a4\u30f3\u3092\u6c7a\u5b9a\u3059\u308b\u969b\u306f\u3001PICO<\/strong>\uff08Patient: \u5bfe\u8c61\u3001Intervention: \u4ecb\u5165\u3001Comparator: \u6bd4\u8f03\u5bfe\u7167\u3001Outcome: \u7d50\u679c\uff1a\u7814\u7a76\u8ab2\u984c\u3092\u6574\u7406\u3059\u308b\u57fa\u672c\u67a0\u7d44\u307f\uff09\u306e\u95a2\u4fc2\u6027\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u304c\u7b2c\u4e00\u6b69\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\u30c7\u30b6\u30a4\u30f3\u3092\u69cb\u6210\u3059\u308b3\u3064\u306e\u67f1<\/strong><\/h3>\n\n\n\n

\u81e8\u5e8a\u8a66\u9a13\u306e\u79d1\u5b66\u7684\u59a5\u5f53\u6027\u3092\u62c5\u4fdd\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u306a\u30013\u3064\u306e\u57fa\u672c\u8981\u7d20\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\u5bfe\u7167\u7fa4\u306e\u8a2d\u5b9a (Control):<\/strong><\/h4>\n\n\n\n
\"\"<\/figure>\n\n\n\n

\u65b0\u85ac\u306e\u52b9\u679c\u3092\u6b63\u3057\u304f\u8a55\u4fa1\u3059\u308b\u306b\u306f\u3001\u6bd4\u8f03\u5bfe\u8c61\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n\n\n\n

\u30d7\u30e9\u30bb\u30dc\u5bfe\u7167<\/strong>\uff08Placebo\uff1a\u6709\u52b9\u6210\u5206\u3092\u542b\u307e\u306a\u3044\u507d\u85ac\uff09\u3001\u5b9f\u85ac\u5bfe\u7167<\/strong>\uff08\u65e2\u5b58\u306e\u6a19\u6e96\u6cbb\u7642\uff09\u3001\u7121\u6cbb\u7642\u5bfe\u7167<\/strong>\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\u5e0c\u5c11\u75be\u60a3\u306a\u3069\u3067\u5bfe\u7167\u7fa4\u3092\u7f6e\u304f\u3053\u3068\u304c\u502b\u7406\u7684\u30fb\u7269\u7406\u7684\u306b\u56f0\u96e3\u306a\u5834\u5408\u306b\u9650\u308a\u3001\u904e\u53bb\u306e\u30c7\u30fc\u30bf\u3092\u7528\u3044\u308b\u30d2\u30b9\u30c8\u30ea\u30ab\u30eb\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\uff08\u5916\u90e8\u5bfe\u7167\uff09\uff08Historical Control\uff1a\u904e\u53bb\u3084\u5916\u90e8\u306e\u30c7\u30fc\u30bf\u3092\u6bd4\u8f03\u5bfe\u8c61\u3068\u3057\u3066\u7528\u3044\u308b\u65b9\u6cd5\uff09\u304c\u8a31\u5bb9\u3055\u308c\u308b\u30b1\u30fc\u30b9\u304c\u3042\u308a\u307e\u3059\u3002
<\/p>\n\n\n\n

\u30e9\u30f3\u30c0\u30e0\u5316 (Randomization):<\/strong><\/h4>\n\n\n\n
\"\"<\/figure>\n\n\n\n

\u53c2\u52a0\u8005\u3092\u4f5c\u70ba\u306a\u304f\u5404\u7fa4\u306b\u5272\u308a\u4ed8\u3051\u308b\u64cd\u4f5c\u3067\u3059\u3002\u5358\u7d14\u30e9\u30f3\u30c0\u30e0\u5316\u3001\u30d6\u30ed\u30c3\u30af\u30e9\u30f3\u30c0\u30e0\u5316\u3001\u5c64\u5225\u30e9\u30f3\u30c0\u30e0\u5316\u306a\u3069\u306e\u624b\u6cd5\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\u6700\u5927\u306e\u76ee\u7684\u306f\u3001\u5e74\u9f62\u3084\u91cd\u75c7\u5ea6\u3068\u3044\u3063\u305f\u65e2\u77e5\u306e\u56e0\u5b50\u3060\u3051\u3067\u306a\u304f\u3001\u300c\u672a\u77e5\u306e\u4ea4\u7d61\u56e0\u5b50\u300d\u3092\u7fa4\u9593\u3067\u5747\u7b49\u306b\u3057\u3001\u30d0\u30a4\u30a2\u30b9\u3092\u5236\u5fa1\u3059\u308b\u3053\u3068\u306b\u3042\u308a\u307e\u3059\uff08\u4ea4\u7d61\u56e0\u5b50\uff1a\u4ecb\u5165\u3068\u7d50\u679c\u306e\u95a2\u4fc2\u3092\u898b\u3048\u306b\u304f\u304f\u3059\u308b\u5225\u306e\u8981\u56e0\uff09\u3002<\/p>\n\n\n\n

\u76f2\u691c\u5316 (Blinding):<\/strong><\/h4>\n\n\n\n
\"\"<\/figure>\n\n\n\n

\u8a66\u9a13\u306b\u53c2\u52a0\u3059\u308b\u95a2\u4fc2\u8005\u304c\u5272\u308a\u4ed8\u3051\u3089\u308c\u305f\u6cbb\u7642\u5185\u5bb9\uff08\u4f8b\uff1a\u5b9f\u85ac\u304b\u30d7\u30e9\u30bb\u30dc\u304b\uff09\u3092\u77e5\u3089\u306a\u3044\u72b6\u614b\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u4e88\u65ad\u3084\u671f\u5f85\u306b\u3088\u308b\u30d0\u30a4\u30a2\u30b9\u3092\u9632\u3050\u624b\u6cd5\u3067\u3059\u3002<\/p>\n\n\n\n

\u5358\u76f2\u691c<\/strong>\uff08\u53c2\u52a0\u8005\u306e\u307f\u96a0\u3059\uff09\u3001\u4e8c\u91cd\u76f2\u691c<\/strong>\uff08\u53c2\u52a0\u8005\u3068\u533b\u5e2b\u5171\u306b\u96a0\u3059\uff09\u3001\u30aa\u30fc\u30d7\u30f3\u30e9\u30d9\u30eb<\/strong>\uff08\u96a0\u3055\u306a\u3044\uff09\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n

\u8fd1\u5e74\u3067\u306f\u3001\u6cbb\u7642\u306f\u30aa\u30fc\u30d7\u30f3\u30e9\u30d9\u30eb\u3067\u884c\u3044\u3064\u3064\u3001\u8a55\u4fa1\u8005\u306e\u307f\u3092\u76f2\u691c\u5316\u3059\u308bPROBE\u6cd5<\/strong>\uff08\u524d\u5411\u304d\u30e9\u30f3\u30c0\u30e0\u5316\u30aa\u30fc\u30d7\u30f3\u30e9\u30d9\u30eb\u8a55\u4fa1\u8005\u76f2\u691c\uff1a\u8a55\u4fa1\u306e\u516c\u5e73\u6027\u3092\u9ad8\u3081\u308b\u5de5\u592b\uff09\u3082\u6d3b\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

\u4ee3\u8868\u7684\u306a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306e\u5206\u985e\u3068\u7279\u5fb4<\/strong><\/h2>\n\n\n\n

\u3053\u3053\u3067\u306f\u8a66\u9a13\u306e\u69cb\u9020\u306b\u3088\u308b\u5206\u985e\u3092\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u307e\u305f\u3001\u30a4\u30e1\u30fc\u30b8\u3057\u3084\u3059\u3044\u3088\u3046\u306b\u30c7\u30b6\u30a4\u30f3\u3054\u3068\u306e\u5177\u4f53\u4f8b\u3082\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u203b\u3042\u304f\u307e\u3067\u3082\u4e00\u4f8b\u3067\u3042\u308a\u3001\u5b9f\u5728\u3059\u308b\u8a66\u9a13\u3092\u6307\u3059\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093<\/p>\n\n\n\n

\u4e26\u884c\u7fa4\u9593\u6bd4\u8f03\u8a66\u9a13 (Parallel Group Design)<\/strong><\/h3>\n\n\n\n
\"\"<\/figure>\n\n\n\n
\u4e26\u884c\u7fa4\u9593\u6bd4\u8f03\u8a66\u9a13<\/strong><\/div>
\n

<\/span>\u7279\u5fb4:<\/strong> \u81e8\u5e8a\u8a66\u9a13\u306e\u30b4\u30fc\u30eb\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\uff08\u6700\u3082\u6a19\u6e96\u7684\u3067\u4fe1\u983c\u6027\u304c\u9ad8\u3044\u3068\u3055\u308c\u308b\u65b9\u6cd5\uff09\u3068\u3055\u308c\u3001\u89e3\u6790\u304c\u30b7\u30f3\u30d7\u30eb\u3067\u7d50\u679c\u306e\u89e3\u91c8\u304c\u5bb9\u6613\u3067\u3059\u3002<\/p>\n\n\n\n

<\/span>\u6ce8\u610f\u70b9:<\/strong> \u7fa4\u9593\u306e\u80cc\u666f\u56e0\u5b50\u3092\u63c3\u3048\u308b\u305f\u3081\u306b\u3001\u6bd4\u8f03\u7684\u591a\u304f\u306e\u75c7\u4f8b\u6570\uff08\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba $N$\uff1a\u89e3\u6790\u306b\u5fc5\u8981\u306a\u53c2\u52a0\u8005\u6570\uff09\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<\/div><\/div>\n\n\n\n

\n

<\/span>\u4f8b\uff1a\u82b1\u7c89\u75c7\u306e\u65b0\u3057\u3044\u98f2\u307f\u85acA\u3092\u8a66\u3057\u305f\u3044<\/span><\/strong><\/p>\n\n\n\n

200\u4eba\u306e\u82b1\u7c89\u75c7\u60a3\u8005\u3092\u30e9\u30f3\u30c0\u30e0\u306b2\u7d44\u306b\u5206\u3051\u308b\u3002<\/p>\n\n\n\n

\u30fbA\u7fa4\uff08100\u4eba\uff09\uff1a\u65b0\u85acA\u3092\u6bce\u65e5<\/p>\n\n\n\n

\u30fbB\u7fa4\uff08100\u4eba\uff09\uff1a\u6a19\u6e96\u85acB\u3092\u6bce\u65e5<\/p>\n\n\n\n

\u4e00\u5b9a\u671f\u9593\u5f8c\u306b\u304f\u3057\u3083\u307f\u56de\u6570\u3001\u9f3b\u3065\u307e\u308a\u30b9\u30b3\u30a2\u3001\u526f\u4f5c\u7528\u3092\u6bd4\u8f03\u3002<\/p>\n<\/div>\n\n\n\n

\u30af\u30ed\u30b9\u30aa\u30fc\u30d0\u30fc\u8a66\u9a13 (Crossover Design)<\/strong><\/h3>\n\n\n\n
\"\"<\/figure>\n\n\n\n
\u30af\u30ed\u30b9\u30aa\u30fc\u30d0\u30fc\u8a66\u9a13<\/strong><\/div>
\n

<\/span>\u69cb\u9020:<\/strong> \u4e00\u4eba\u306e\u53c2\u52a0\u8005\u304c\u3001\u6642\u671f\u3092\u305a\u3089\u3057\u3066\u300c\u5b9f\u85ac\u300d\u3068\u300c\u30d7\u30e9\u30bb\u30dc\uff08\u307e\u305f\u306f\u5bfe\u7167\u85ac\uff09\u300d\u306e\u4e21\u65b9\u3092\u9806\u306b\u8a66\u3057\u307e\u3059\uff08\u81ea\u5df1\u5bfe\u7167\uff1a\u540c\u3058\u4eba\u304c\u81ea\u5206\u81ea\u8eab\u306e\u6bd4\u8f03\u5bfe\u8c61\u306b\u306a\u308b\u8003\u3048\u65b9\uff09\u3002<\/p>\n\n\n\n

<\/span>\u7279\u5fb4:<\/strong> \u500b\u4eba\u5dee\u306e\u5f71\u97ff\u3092\u9664\u5916\u3067\u304d\u308b\u305f\u3081\u3001\u5c11\u4eba\u6570\u3067\u3082\u9ad8\u3044\u691c\u51fa\u529b\uff08\u691c\u51fa\u529b\uff1a\u672c\u5f53\u306b\u5dee\u304c\u3042\u308b\u3068\u304d\u306b\u5dee\u3092\u898b\u3064\u3051\u3089\u308c\u308b\u78ba\u7387\uff09\u3092\u6301\u3061\u307e\u3059\u3002<\/p>\n\n\n\n

<\/span>\u5fc5\u9808\u6761\u4ef6:<\/strong><\/p>\n\n\n\n

    \n
  1. \u75c7\u72b6\u304c\u5b89\u5b9a\u3057\u3066\u3044\u308b\u6162\u6027\u75be\u60a3\u3067\u3042\u308b\u3053\u3068\u3002<\/li>\n\n\n\n
  2. \u524d\u306e\u85ac\u306e\u5f71\u97ff\u3092\u6d88\u3059\u305f\u3081\u306e\u30a6\u30a9\u30c3\u30b7\u30e5\u30a2\u30a6\u30c8\u671f\u9593\uff08\u30a6\u30a9\u30c3\u30b7\u30e5\u30a2\u30a6\u30c8\u671f\u9593\uff1a\u524d\u6cbb\u7642\u306e\u5f71\u97ff\u304c\u6b8b\u3089\u306a\u3044\u3088\u3046\u306b\u7a7a\u3051\u308b\u671f\u9593\uff09\u306e\u8a2d\u5b9a\u3002<\/li>\n\n\n\n
  3. \u524d\u306e\u6cbb\u7642\u52b9\u679c\u304c\u5f8c\u306e\u671f\u9593\u306b\u5f71\u97ff\u3057\u306a\u3044\u3053\u3068\uff08\u6301\u3061\u8d8a\u3057\u52b9\u679c\u304c\u306a\u3044\u3053\u3068\uff09\u3002<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n
    \n

    <\/span>\u4f8b<\/strong>\uff1a\u6162\u6027\u306e\u4e0d\u7720\u75c7\u3067\u3001\u65b0\u3057\u3044\u7761\u7720\u85acA\u304c\u672c\u5f53\u306b\u52b9\u304f\u304b\u898b\u305f\u3044<\/strong><\/span><\/p>\n\n\n\n

    \u540c\u3058\u60a3\u8005\u304cA\u3068B\u306e\u4e21\u65b9\u3092\u4f53\u9a13\u3059\u308b\u3002<\/p>\n\n\n\n

      \n
    • \u671f\u95931\uff082\u9031\u9593\uff09\uff1a\u7761\u7720\u85acA<\/li>\n\n\n\n
    • \u4f11\u85ac\uff081\u9031\u9593\uff09\uff1a\u30a6\u30a9\u30c3\u30b7\u30e5\u30a2\u30a6\u30c8<\/li>\n\n\n\n
    • \u671f\u95932\uff082\u9031\u9593\uff09\uff1a\u30d7\u30e9\u30bb\u30dcB<\/li>\n<\/ul>\n\n\n\n

      \u5225\u306e\u30b0\u30eb\u30fc\u30d7\u306f\u9806\u756a\u304c\u9006\uff08B\u2192A\uff09\u3002<\/p>\n\n\n\n

      \u5404\u671f\u9593\u3067 \u5165\u7720\u307e\u3067\u306e\u6642\u9593\u3084\u4e2d\u9014\u899a\u9192\u56de\u6570\u3092\u6bd4\u8f03\u3002<\/p>\n<\/div>\n\n\n\n

      \u305d\u306e\u4ed6\u306e\u91cd\u8981\u306a\u30c7\u30b6\u30a4\u30f3<\/strong><\/h3>\n\n\n\n

      \u8981\u56e0\u914d\u7f6e\u8a66\u9a13 (Factorial Design)<\/strong><\/h4>\n\n\n\n

      2\u7a2e\u985e\u306e\u85ac\u5264\u306e\u5358\u72ec\u52b9\u679c\u3068\u4f75\u7528\u52b9\u679c\u3092\u540c\u6642\u306b\u691c\u8a3c\u3059\u308b\u5834\u5408\u306a\u3069\u306b\u7528\u3044\u3089\u308c\u307e\u3059\uff08\u8907\u6570\u4ecb\u5165\u3092\u52b9\u7387\u3088\u304f\u8a55\u4fa1\u3059\u308b\u67a0\u7d44\u307f\uff09\u3002<\/p>\n\n\n\n

      \n

      <\/span>\u4f8b\uff1a\u9ad8\u8840\u5727\u4e88\u9632\u3067\u300c\u6e1b\u5869\u300d\u3068\u300c\u904b\u52d5\u300d\u306e\u52b9\u679c\u3092\u540c\u6642\u306b\u691c\u8a3c\u3057\u305f\u3044<\/span><\/strong><\/span><\/strong><\/p>\n\n\n\n

      \u53c2\u52a0\u8005\u3092\u4e0b\u8a18\u306e4\u7fa4\u306b\u30e9\u30f3\u30c0\u30e0\u5316\uff1a<\/p>\n\n\n\n

        \n
      • \u6e1b\u5869\u3042\u308a \uff0b \u904b\u52d5\u3042\u308a<\/li>\n\n\n\n
      • \u6e1b\u5869\u3042\u308a \uff0b \u904b\u52d5\u306a\u3057<\/li>\n\n\n\n
      • \u6e1b\u5869\u306a\u3057 \uff0b \u904b\u52d5\u3042\u308a<\/li>\n\n\n\n
      • \u6e1b\u5869\u306a\u3057 \uff0b \u904b\u52d5\u306a\u3057<\/li>\n<\/ul>\n\n\n\n

        \u4e00\u5b9a\u671f\u9593\u5f8c\u306b\u3001\u53ce\u7e2e\u671f\u8840\u5727\u3084\u62e1\u5f35\u671f\u8840\u5727\u3092\u6bd4\u8f03\u3002<\/p>\n<\/div>\n\n\n\n

        \u7fa4\u30e9\u30f3\u30c0\u30e0\u5316\u8a66\u9a13 (Cluster RCT)<\/strong><\/h4>\n\n\n\n

        \u500b\u4eba\u5358\u4f4d\u3067\u306f\u306a\u304f\u3001\u300c\u75c5\u9662\u300d\u3084\u300c\u5730\u57df\u300d\u5358\u4f4d\u3067\u5272\u308a\u4ed8\u3051\u3092\u884c\u3044\u307e\u3059\uff08\u96c6\u56e3\u5358\u4f4d\u3067\u4ecb\u5165\u306e\u52b9\u679c\u3092\u307f\u308b\u65b9\u6cd5\uff09\u3002<\/p>\n\n\n\n

        \n

        <\/span>\u4f8b\uff1a\u5b66\u6821\u5358\u4f4d\u3067\u611f\u67d3\u5bfe\u7b56\u304c\u52b9\u304f\u304b\u3092\u898b\u305f\u3044<\/span><\/strong><\/p>\n\n\n\n

        A\u6821\uff1a\u624b\u6d17\u3044\u6559\u80b2\uff0b\u6559\u5ba4\u306b\u6d88\u6bd2\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u8ffd\u52a0<\/p>\n\n\n\n

        B\u6821\uff1a\u901a\u5e38\u306e\u885b\u751f\u6307\u5c0e<\/p>\n\n\n\n

        \u500b\u4eba\u3067\u306f\u306a\u304f\u5b66\u6821\u3068\u3044\u3046\u201c\u96c6\u56e3\u201d\u3092\u30e9\u30f3\u30c0\u30e0\u306b\u5272\u308a\u4ed8\u3051\u3066\u3001\u51ac\u306e\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u6b20\u5e2d\u7387\u3092\u6bd4\u8f03\u3002<\/p>\n<\/div>\n\n\n\n

        \u7fa4\u30e9\u30f3\u30c0\u30e0\u5316\u8a66\u9a13\u306e\u4ee3\u8868\u7684\u306a\u6ce8\u610f\u70b9<\/strong><\/div>
        \n

        <\/span>\u5fc5\u8981\u306a\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u304c\u5927\u5e45\u306b\u5897\u3048\u308b<\/strong>\uff1a\u540c\u3058\u5b66\u6821\u306e\u751f\u5f92\u540c\u58eb\u306f\u751f\u6d3b\u74b0\u5883\u304c\u4f3c\u3066\u3044\u308b\u305f\u3081\u3001\u30c7\u30fc\u30bf\u3068\u3057\u3066\u3082\u4f3c\u305f\u50be\u5411\u3092\u6301\u3061\u307e\u3059\uff08\u72ec\u7acb\u6027\u304c\u4f4e\u3044\uff09\u3002<\/p>\n\n\n\n

        \u305d\u306e\u305f\u3081\u3001\u7d71\u8a08\u7684\u306a\u300c\u60c5\u5831\u306e\u4fa1\u5024\u300d\u304c\u76ee\u6e1b\u308a\u3057\u307e\u3059\u3002\u500b\u4eba\u5358\u4f4d\u306e\u8a66\u9a13\u3068\u540c\u3058\u611f\u899a\u3067\u4eba\u6570\u8a08\u7b97\u3092\u3059\u308b\u3068\u3001\u672c\u5f53\u306f\u52b9\u679c\u304c\u3042\u308b\u306e\u306b\u300c\u5dee\u306a\u3057\u300d\u3068\u3044\u3046\u7d50\u679c\u306b\u306a\u308a\u304c\u3061\u3067\u3059\u3002<\/p>\n<\/div><\/div>\n\n\n\n

        \u6c17\u3065\u304d\u306b\u304f\u3044\u843d\u3068\u3057\u7a74<\/strong><\/div>
        \n

        <\/span>\u540c\u610f\u53d6\u5f97\u3068\u5272\u308a\u4ed8\u3051\u306e\u300c\u9806\u5e8f\u300d\u3092\u9593\u9055\u3048\u308b<\/strong> \u300cA\u6821\u306f\u65b0\u3057\u3044\u5bfe\u7b56\u3042\u308a\u300d\u3068\u6c7a\u307e\u3063\u305f \u201c<\/strong>\u5f8c\u201d<\/strong> \u306b\u751f\u5f92\u3078\u53c2\u52a0\u3092\u52df\u308b\u3068\u3001\u300c\u65b0\u3057\u3044\u5bfe\u7b56\u304c\u3042\u308b\u306a\u3089\u53c2\u52a0\u3057\u305f\u3044\u300d\u3068\u3044\u3046\u4eba\u304c\u5897\u3048\u3001\u7fa4\u9593\u306e\u516c\u5e73\u6027\u304c\u5d29\u308c\u3066\u3057\u307e\u3044\u307e\u3059\uff08\u9078\u629e\u30d0\u30a4\u30a2\u30b9\uff09\u3002<\/p>\n\n\n\n

        \u300c\u5168\u54e1\u306e\u53c2\u52a0\u540c\u610f\u3092\u53d6\u308b \u2192 \u305d\u306e\u5f8c\u306b\u5b66\u6821\u3092\u5272\u308a\u4ed8\u3051\u308b\u300d \u3068\u3044\u3046\u9806\u5e8f\u3092\u53b3\u5b88\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/div><\/div>\n\n\n\n

        \u30de\u30c3\u30c1\u30c9\u30da\u30a2\u8a66\u9a13<\/h4>\n\n\n\n

        \u6027\u5225\u30fb\u5e74\u9f62\u30fb\u91cd\u75c7\u5ea6\u306a\u3069\u306e\u7279\u5fb4\u304c\u4f3c\u305f\u60a3\u8005\u3092\u30da\u30a2\u306b\u3057\u3001\u305d\u308c\u305e\u308c\u3092\u5225\u3005\u306e\u7fa4\u306b\u5272\u308a\u4ed8\u3051\u308b\u3053\u3068\u3067\u80cc\u666f\u56e0\u5b50\u3092\u8abf\u6574\u3059\u308b\u624b\u6cd5\u3067\u3059\uff08\u80cc\u666f\u5dee\u3092\u3067\u304d\u308b\u3060\u3051\u5c0f\u3055\u304f\u3059\u308b\u5de5\u592b\uff09\u3002<\/p>\n\n\n\n

        \n

        <\/span>\u4f8b\uff1a\u8853\u5f8c\u306e\u75db\u307f\u6b62\u3081A\u3068B\u3092\u6bd4\u3079\u305f\u3044\u304c\u3001\u60a3\u8005\u306e\u5dee\u3092\u6975\u529b\u6e1b\u3089\u3057\u305f\u3044<\/span><\/strong><\/p>\n\n\n\n

          \n
        • \u5e74\u9f62<\/li>\n\n\n\n
        • \u6027\u5225<\/li>\n\n\n\n
        • \u624b\u8853\u5185\u5bb9<\/li>\n\n\n\n
        • \u75db\u307f\u306e\u91cd\u75c7\u5ea6<\/li>\n<\/ul>\n\n\n\n

          \u304c\u4f3c\u3066\u3044\u308b\u60a3\u8005\u30922\u4eba1\u7d44\u3067\u30da\u30a2\u306b\u3059\u308b\u3002<\/p>\n\n\n\n

          \u30da\u30a2\u5185\u3067<\/p>\n\n\n\n

            \n
          • \u7247\u65b9\uff1a\u93ae\u75db\u85acA<\/li>\n\n\n\n
          • \u7247\u65b9\uff1a\u93ae\u75db\u85acB<\/li>\n<\/ul>\n\n\n\n

            \u3092\u4f7f\u3044\u300124\u6642\u9593\u306e\u75db\u307f\u30b9\u30b3\u30a2\u3092\u6bd4\u8f03\u3002<\/p>\n<\/div>\n\n\n\n

            \u958b\u767a\u30d5\u30a7\u30fc\u30ba\u3054\u3068\u306e\u6a19\u6e96\u7684\u30c7\u30b6\u30a4\u30f3\u3068\u304c\u3093\u9818\u57df\u306e\u7279\u4f8b<\/strong><\/h2>\n\n\n\n
            \"\"<\/figure>\n\n\n\n

            \u7b2cI\u76f8\u8a66\u9a13\uff08\u63a2\u7d22\u7684\u8a66\u9a13\uff09\uff1a\u5b89\u5168\u6027\u3092\u3069\u3046\u898b\u6975\u3081\u308b\u304b<\/strong><\/h3>\n\n\n\n

            SAD\u3068MAD<\/strong><\/h4>\n\n\n\n

            \u4e00\u822c\u7684\u306a\u85ac\u5264\u3067\u306f\u3001\u5065\u5e38\u4eba\u3092\u5bfe\u8c61\u306b\u5358\u56de\u6295\u4e0e\uff08SAD\uff1aSingle Ascending Dose\uff1a\u5358\u56de\u6295\u4e0e\u3067\u7528\u91cf\u3092\u6bb5\u968e\u7684\u306b\u5897\u3084\u3059\u8a66\u9a13\uff09\u304b\u3089\u958b\u59cb\u3057\u3001\u5b89\u5168\u6027\u3092\u78ba\u8a8d\u5f8c\u306b\u53cd\u5fa9\u6295\u4e0e\uff08MAD\uff1aMultiple Ascending Dose\uff1a\u8907\u6570\u56de\u6295\u4e0e\u3067\u7528\u91cf\u3092\u5897\u3084\u3059\u8a66\u9a13\uff09\u3078\u79fb\u884c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

            \u304c\u3093\u9818\u57df\u306e\u7b2cI\u76f8\uff08Oncology Phase 1\uff09<\/strong><\/h4>\n\n\n\n

            \u6297\u304c\u3093\u5264\u306f\u7d30\u80de\u6bd2\u6027\u304c\u5f37\u3044\u305f\u3081\u3001\u60a3\u8005\u3092\u5bfe\u8c61\u306b\u884c\u308f\u308c\u307e\u3059\u3002<\/p>\n\n\n\n

            <\/span>3+3\u6cd5<\/strong><\/p>\n\n\n\n

            3\u4eba\u306e\u30b3\u30db\u30fc\u30c8\uff08Cohort\uff1a\u540c\u3058\u7528\u91cf\u306a\u3069\u540c\u6761\u4ef6\u306e\u60a3\u8005\u96c6\u56e3\uff09\u3054\u3068\u306b\u7528\u91cf\u3092\u4e0a\u3052\u3001\u6bd2\u6027\uff08DLT\uff1aDose Limiting Toxicity\uff1a\u7528\u91cf\u5236\u9650\u6bd2\u6027\uff09\u306e\u767a\u73fe\u72b6\u6cc1\u3067\u6b21\u306e\u7528\u91cf\u3092\u6c7a\u3081\u308b\u4f1d\u7d71\u7684\u306a\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3067\u3059\u3002<\/p>\n\n\n\n

            \u4f8b\u3048\u3070\u3001\u65b0\u3057\u3044\u85ac\u3092\u300c\u30ec\u30d9\u30eb1\uff08\u5c11\u91cf\uff09\u300d\u304b\u3089\u300c\u30ec\u30d9\u30eb3\uff08\u591a\u91cf\uff09\u300d\u307e\u3067\u8a66\u3059\u3068\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

            1<\/div>
            \u30ec\u30d9\u30eb1\uff0810mg\uff09\u3092\u6295\u4e0e<\/strong><\/div>

            \u307e\u305a3\u4eba<\/strong>\u306e\u60a3\u8005\u3055\u3093\u306b\u6295\u4e0e\u3057\u307e\u3057\u305f\u3002
            \u7d50\u679c\uff1a<\/strong> 3\u4eba\u3068\u3082DLT\uff08\u91cd\u3044\u526f\u4f5c\u7528\uff09\u306f\u51fa\u307e\u305b\u3093\u3067\u3057\u305f\uff080\/3\u4eba\uff09\u3002
            \u5224\u5b9a\uff1a<\/strong> \u300c\u3053\u306e\u91cf\u306f\u5b89\u5168\u300d\u3068\u5224\u65ad\u3057\u3001\u6b21\u306e\u30ec\u30d9\u30eb\u3078\u5897\u91cf<\/strong>\u3057\u307e\u3059\u3002<\/p><\/div><\/div>

            2<\/div>
            \u30ec\u30d9\u30eb2\uff0820mg\uff09\u3092\u6295\u4e0e<\/strong><\/div>

            \u6b21\u306e3\u4eba<\/strong>\u306b\u3001\u500d\u306e\u91cf\u3092\u6295\u4e0e\u3057\u307e\u3057\u305f\u3002
            \u7d50\u679c\uff1a<\/strong> 1\u4eba<\/strong>\u306bDLT\u304c\u51fa\u307e\u3057\u305f\uff081\/3\u4eba\uff09\u3002
            \u5224\u5b9a\uff1a<\/strong> \u300c\u305f\u307e\u305f\u307e\u3053\u306e\u4eba\u306e\u4f53\u8abf\u304c\u60aa\u304b\u3063\u305f\u306e\u304b\u3001\u85ac\u304c\u5f37\u3059\u304e\u308b\u306e\u304b\uff1f\u300d\u5224\u65ad\u304c\u3064\u304d\u307e\u305b\u3093\u3002 \u305d\u306e\u305f\u3081\u3001\u540c\u3058\u30ec\u30d9\u30eb2\u3067\u3001\u3055\u3089\u306b\u300c3\u4eba\u300d\u3092\u8ffd\u52a0\u3057\u307e\u3059<\/strong>\uff08\u3053\u308c\u304c”3+3″\u306e\u540d\u524d\u306e\u7531\u6765\u3067\u3059\uff09\u3002
            \u8ffd\u52a0\u7d50\u679c\uff1a<\/strong> \u5408\u8a086\u4eba\uff08\u6700\u521d\u306e3\u4eba\uff0b\u8ffd\u52a0\u306e3\u4eba\uff09\u3067\u898b\u308b\u3068\u3001DLT\u304c\u51fa\u305f\u306e\u306f\u6700\u521d\u306e1\u4eba\u3060\u3051\u3067\u3057\u305f\uff081\/6\u4eba\uff09\u3002
            \u6700\u7d42\u5224\u5b9a\uff1a<\/strong> \u300c6\u4eba\u4e2d1\u4eba\u306a\u3089\u8a31\u5bb9\u7bc4\u56f2\u300d\u3068\u3057\u3066\u3001\u6b21\u306e\u30ec\u30d9\u30eb\u3078\u5897\u91cf<\/strong>\u3057\u307e\u3059\u3002<\/p><\/div><\/div>

            3<\/div>
            \u30ec\u30d9\u30eb3\uff0830mg\uff09\u3092\u6295\u4e0e<\/strong><\/div>

            \u6b21\u306e3\u4eba<\/strong>\u306b\u3055\u3089\u306b\u591a\u3044\u91cf\u3092\u6295\u4e0e\u3057\u307e\u3057\u305f\u3002
            \u7d50\u679c\uff1a<\/strong> 2\u4eba<\/strong>\u306bDLT\u304c\u51fa\u307e\u3057\u305f\uff082\/3\u4eba\uff09\u3002
            \u5224\u5b9a\uff1a<\/strong> \u300c\u3053\u308c\u306f\u5371\u967a\u3059\u304e\u308b\u300d\u3068\u5224\u65ad\u3057\u3001\u3053\u3053\u3067\u30b9\u30c8\u30c3\u30d7<\/strong>\u3057\u307e\u3059\u3002<\/p><\/div><\/div><\/div><\/div>\n\n\n\n

            <\/span>CRM (Continual Reassessment Method)<\/strong><\/p>\n\n\n\n

            \u7d71\u8a08\u30e2\u30c7\u30eb\u3092\u7528\u3044\u3066\u3001\u3088\u308a\u6b63\u78ba\u306bMTD\uff08\u6700\u5927\u8010\u91cf\uff1a\u526f\u4f5c\u7528\u304c\u8a31\u5bb9\u3067\u304d\u308b\u7bc4\u56f2\u3067\u306e\u6700\u5927\u7528\u91cf\uff09\u3092\u63a8\u5b9a\u3059\u308b\u624b\u6cd5\u3067\u3059\u3002<\/p>\n\n\n\n

            CRM\u306f3+3\u6cd5\u3088\u308a\u3082\u3055\u3089\u306b\u300c\u6570\u5b66\u7684\uff08\u7d71\u8a08\u5b66\u7684\uff09\u300d\u306b\u3001\u6700\u9069\u306a\u6295\u4e0e\u91cf\u3092\u63a2\u308a\u5f53\u3066\u308b\u65b9\u6cd5\u3067\u3059\u3002<\/p>\n\n\n\n

            1<\/div>
            \u4e88\u6e2c<\/strong><\/div>

            \u6700\u521d\u306b\u3001\u533b\u5e2b\u3068\u7d71\u8a08\u5bb6\u304c\u300c\u304a\u305d\u3089\u304f\u3053\u306e\u91cf\u3067\u526f\u4f5c\u7528\u3007\u3007%\u304f\u3089\u3044\u306b\u306a\u308b\u3060\u308d\u3046\u300d\u3068\u3044\u3046\u4e88\u6e2c\u30ab\u30fc\u30d6\uff08\u66f2\u7dda\uff09\u3092\u63cf\u304d\u307e\u3059\u3002<\/p><\/div><\/div>

            2<\/div>
            \u5b9f\u884c<\/strong><\/div>

            \u6700\u521d\u306e\u60a3\u8005\u3055\u3093\u306b\u6295\u4e0e\u3057\u307e\u3059\u3002<\/p><\/div><\/div>

            3<\/div>
            \u518d\u8a08\u7b97<\/strong><\/div>

            <\/span>\u60a3\u8005\u3055\u3093\u306b\u526f\u4f5c\u7528\u304c\u51fa\u306a\u304b\u3063\u305f<\/strong>\u5834\u5408 \u2192 \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u304c\u8a08\u7b97\uff1a\u300c\u601d\u3063\u3066\u3044\u305f\u3088\u308a\u85ac\u304c\u5f31\u3044\uff08\u5b89\u5168\uff09\u3088\u3046\u3067\u3059\u3002\u4e88\u6e2c\u30ab\u30fc\u30d6\u3092\u4fee\u6b63\u3057\u307e\u3059\u3002\u6b21\u306f\u3082\u3063\u3068\u591a\u3044\u91cf\u306730%\u3092\u72d9\u3044\u307e\u3057\u3087\u3046\u300d
            <\/span>\u60a3\u8005\u3055\u3093\u306b\u526f\u4f5c\u7528\u304c\u51fa\u305f<\/strong>\u5834\u5408 \u2192 \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u304c\u8a08\u7b97\uff1a\u300c\u601d\u3063\u3066\u3044\u305f\u3088\u308a\u85ac\u304c\u5f37\u3044\uff08\u5371\u967a\uff09\u3088\u3046\u3067\u3059\u3002\u4e88\u6e2c\u30ab\u30fc\u30d6\u3092\u4fee\u6b63\u3057\u307e\u3059\u3002\u6b21\u306f\u5c11\u3057\u91cf\u3092\u6e1b\u3089\u3057\u306630%\u3092\u72d9\u3044\u307e\u3057\u3087\u3046\u300d<\/p><\/div><\/div>

            4<\/div>
            \u7e70\u308a\u8fd4\u3057<\/strong><\/div>

            \u3053\u308c\u3092\u60a3\u8005\u3055\u30931\u4eba\uff08\u307e\u305f\u306f\u6570\u4eba\uff09\u3054\u3068\u306b\u7e70\u308a\u8fd4\u3057\u3001\u6700\u7d42\u7684\u306b\u300c\u526f\u4f5c\u7528\u767a\u751f\u7387\u304c\u3061\u3087\u3046\u3069\u3007\u3007%\u306b\u306a\u308b\u91cf\uff08MTD\uff09\u300d\u3092\u30d4\u30f3\u30dd\u30a4\u30f3\u30c8\u3067\u7279\u5b9a\u3057\u307e\u3059\u3002<\/p><\/div><\/div><\/div><\/div>\n\n\n\n

            \u63a8\u5968\u7528\u91cf\u6c7a\u5b9a\u5f8c\u306b\u75c7\u4f8b\u3092\u8ffd\u52a0\u3057\u3001\u6709\u52b9\u6027\u306e\u30b7\u30b0\u30ca\u30eb\u3092\u65e9\u671f\u306b\u63b4\u3080\u5de5\u592b\u304c\u884c\u308f\u308c\u307e\u3059\uff08\u5b89\u5168\u6027\u3060\u3051\u3067\u306a\u304f\u52b9\u679c\u306e\u5146\u3057\u3082\u78ba\u8a8d\u3059\u308b\u76ee\u7684\uff09\u3002<\/p>\n\n\n\n

            \u7b2cII\u76f8\u8a66\u9a13\uff08\u65b0\u85ac\u3068\u3057\u3066\u306e\u300c\u6709\u671b\u3055\u300d\u3092\u78ba\u8a8d\u3059\u308b\u6bb5\u968e\uff09\uff1aPOC\u306e\u78ba\u8a8d<\/strong><\/h3>\n\n\n\n

            \u7528\u91cf\u53cd\u5fdc\u6027\u306e\u691c\u8a0e\u304a\u3088\u3073POC\uff08Proof of Concept\uff1a\u6982\u5ff5\u5b9f\u8a3c\uff09\u306e\u78ba\u8a8d\u3092\u884c\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

            \u7c21\u5358\u306b\u8a00\u3046\u3068\u3001POC\u306f\u300c\u673a\u4e0a\u306e\u7a7a\u8ad6\u3067\u306f\u306a\u3044\u3053\u3068\u306e\u8a3c\u660e\u300d\u3092\u610f\u5473\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

            \u5b9f\u969b\u306b\u5c11\u6570\u306e\u60a3\u8005\u3055\u3093\u306b\u6295\u4e0e\u3057\u3001\u300c\u672c\u5f53\u306b\u85ac\u3068\u3057\u3066\u671f\u5f85\u3067\u304d\u308b\u304b\u300d\u3068\u3044\u3046\u78ba\u304b\u306a\u624b\u5fdc\u3048\u3092\u63b4\u3080\u3053\u3068\u304c\u3001\u3053\u306e\u8a66\u9a13\u306e\u6700\u5927\u306e\u30b4\u30fc\u30eb\u3067\u3059\u3002<\/p>\n\n\n\n

            \u5358\u7fa4\u8a66\u9a13\u306e\u53ef\u5426<\/strong><\/h4>\n\n\n\n

            \u4e88\u5f8c\u4e0d\u826f\u306a\u304c\u3093\u3084\u5e0c\u5c11\u75be\u60a3\u306b\u304a\u3044\u3066\u3001\u904e\u53bb\u306e\u60a3\u8005\u30c7\u30fc\u30bf\u3068\u6bd4\u8f03\u3057\u3066\u660e\u3089\u304b\u306b\u9ad8\u3044\u594f\u52b9\u7387(\u816b\u760d\u304c\u660e\u3089\u304b\u306b\u7e2e\u3093\u3060\u4eba\u306e\u5272\u5408)\u304c\u671f\u5f85\u3067\u304d\u308b\u5834\u5408\u3001\u5bfe\u7167\u7fa4\u3092\u7f6e\u304b\u306a\u3044\u5358\u7fa4\u8a66\u9a13\u304c\u884c\u308f\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\uff08\u502b\u7406\u7684\u30fb\u5b9f\u52d9\u7684\u5236\u7d04\u3078\u306e\u5bfe\u5fdc\uff09\u3002<\/p>\n\n\n\n

            Simon\u306e2\u6bb5\u968e\u30c7\u30b6\u30a4\u30f3<\/strong><\/h4>\n\n\n\n

            \u7b2c\u4e00\u6bb5\u968e\u3067\u52b9\u679c\u304c\u898b\u3089\u308c\u306a\u3044\u5834\u5408\u3001\u7121\u76ca\u306a\u6cbb\u7642\u3092\u65e9\u671f\u306b\u4e2d\u6b62\uff08Futility stop\uff1a\u6709\u52b9\u6027\u304c\u898b\u8fbc\u3081\u306a\u3044\u3068\u5224\u65ad\u3057\u3066\u4e2d\u6b62\u3059\u308b\u3053\u3068\uff09\u3057\u3001\u60a3\u8005\u306e\u4e0d\u5229\u76ca\u3068\u958b\u767a\u30b3\u30b9\u30c8\u3092\u6291\u3048\u308b\u30c7\u30b6\u30a4\u30f3\u3067\u3059\u3002<\/p>\n\n\n\n

            \u4e3b\u306b\u304c\u3093\u306e\u7b2cII\u76f8\u8a66\u9a13\u3067\u4f7f\u308f\u308c\u308b\u3001\u975e\u5e38\u306b\u6709\u540d\u306a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3067\u3059\u3002<\/p>\n\n\n\n

            \u4e00\u8a00\u3067\u8a00\u3046\u3068\u3001\u300c\u898b\u8fbc\u307f\u306e\u306a\u3044\u85ac\u306f\u3001\u65e9\u3081\u306b\u898b\u5207\u308a\u3092\u3064\u3051\u3066\u8a66\u9a13\u3092\u30b9\u30c8\u30c3\u30d7\u3059\u308b\uff08\u7121\u52b9\u4e2d\u6b62\uff09\u300d\u305f\u3081\u306e\u4ed5\u7d44\u307f\u3067\u3059\u3002<\/p>\n\n\n\n

            \u7b2cIII\u76f8\u8a66\u9a13\uff08\u691c\u8a3c\u7684\u8a66\u9a13\uff09\uff1a\u512a\u8d8a\u6027\u30fb\u975e\u52a3\u6027\u30fb\u540c\u7b49\u6027<\/strong><\/h3>\n\n\n\n

            \u5927\u898f\u6a21\u306aRCT\u306b\u3088\u308a\u3001\u6a19\u6e96\u6cbb\u7642\u306b\u5bfe\u3059\u308b\u4f4d\u7f6e\u3065\u3051\u3092\u78ba\u5b9a\u3055\u305b\u307e\u3059\u3002<\/p>\n\n\n\n

            \u512a\u8d8a\u6027\u8a66\u9a13<\/strong><\/h4>\n\n\n\n

            \u65b0\u85ac\u304c\u5bfe\u7167\u85ac\u3088\u308a\u512a\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3002<\/p>\n\n\n\n

            \u975e\u52a3\u6027\u8a66\u9a13<\/strong><\/h4>\n\n\n\n

            \u65b0\u85ac\u304c\u5bfe\u7167\u85ac\u3088\u308a\u300c\u52a3\u3063\u3066\u3044\u306a\u3044\u300d\u3053\u3068\u3092\u793a\u3059\uff08\u52b9\u679c\u304c\u540c\u7a0b\u5ea6\u3067\u3082\u5b89\u5168\u6027\u3084\u5229\u4fbf\u6027\u3067\u4fa1\u5024\u304c\u3042\u308b\u5834\u5408\u306b\u91cd\u8981\uff09\u3002<\/p>\n\n\n\n

            \u3053\u308c\u306b\u306f\u53b3\u5bc6\u306a\u300c\u975e\u52a3\u6027\u30de\u30fc\u30b8\u30f3\u300d\uff08Non-inferiority Margin\uff1a\u8a31\u5bb9\u3067\u304d\u308b\u5dee\u306e\u4e0a\u9650\uff09\u306e\u8a2d\u5b9a\u3068\u3001\u5fc5\u8981\u306a\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u306e\u5897\u5927\u304c\u4f34\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

            \u8fd1\u5e74\u306e\u30c8\u30ec\u30f3\u30c9\u300cComplex Innovative Design (CID)\u300d<\/strong><\/h2>\n\n\n\n
            \"\"<\/figure>\n\n\n\n

            \u500b\u5225\u5316\u533b\u7642\uff08\u30d7\u30ec\u30b7\u30b8\u30e7\u30f3\u30e1\u30c7\u30a3\u30b7\u30f3\uff1a\u907a\u4f1d\u5b50\u306a\u3069\u500b\u4eba\u5dee\u306b\u57fa\u3065\u304d\u6700\u9069\u6cbb\u7642\u3092\u9078\u3076\u533b\u7642\uff09\u306e\u9032\u5c55\u306b\u4f34\u3044\u3001\u5f93\u6765\u306e\u67a0\u7d44\u307f\u3092\u8d85\u3048\u305f\u30c7\u30b6\u30a4\u30f3\u304c\u6025\u5897\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

            \u30de\u30b9\u30bf\u30fc\u30d7\u30ed\u30c8\u30b3\u30eb\uff1a\u30d0\u30b9\u30b1\u30c3\u30c8\u8a66\u9a13\u3068\u30a2\u30f3\u30d6\u30ec\u30e9\u8a66\u9a13<\/strong><\/h3>\n\n\n\n

            \u30de\u30b9\u30bf\u30fc\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u30011\u3064\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3067\u8907\u6570\u306e\u30b5\u30d6\u8a66\u9a13\u3092\u884c\u3046\u52b9\u7387\u7684\u306a\u30c7\u30b6\u30a4\u30f3\u3067\u3059\u3002<\/p>\n\n\n\n

            \u304c\u3093\u9818\u57df\u3092\u4e2d\u5fc3\u306b\u6d3b\u7528\u3055\u308c\u3066\u3044\u308b\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3067\u3059\u304c\u3001\u4eca\u5f8c\u4ed6\u306e\u9818\u57df\u3067\u3082\u6d3b\u7528\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

            \u30d0\u30b9\u30b1\u30c3\u30c8\u8a66\u9a13 (Basket Trial)<\/strong><\/h4>\n\n\n\n

            \u300c1\u3064\u306e\u85ac \u00d7 \u8907\u6570\u306e\u304c\u3093\u7a2e\u300d<\/strong>\u3002<\/p>\n\n\n\n

            \u81d3\u5668\u306b\u95a2\u308f\u3089\u305a\u3001\u5171\u901a\u306e\u907a\u4f1d\u5b50\u5909\u7570\u3092\u6301\u3064\u60a3\u8005\u3092\u96c6\u3081\u3066\u7279\u5b9a\u306e\u5206\u5b50\u6a19\u7684\u85ac\u3092\u8a55\u4fa1\u3057\u307e\u3059\uff08\u540c\u3058\u5206\u5b50\u7570\u5e38\u3092\u8ef8\u306b\u60a3\u8005\u3092\u307e\u3068\u3081\u308b\u8003\u3048\u65b9\uff09\u3002(\u53c2\u8003\uff1a\u65e5\u672c\u88fd\u85ac\u5de5\u696d\u5354\u4f1a 4)<\/p>\n\n\n\n

            \n

            <\/span>\u4f8b\uff1a\u540c\u3058\u907a\u4f1d\u5b50\u5909\u7570\u201d\u3092\u6301\u3064\u306a\u3089\u3001\u304c\u3093\u306e\u81d3\u5668\u304c\u9055\u3063\u3066\u3082\u540c\u3058\u85ac\u304c\u52b9\u304f\u304b\u3092\u691c\u8a3c\u3057\u305f\u3044<\/span><\/strong><\/span><\/strong><\/p>\n\n\n\n

              \n
            • \u80ba\u304c\u3093<\/li>\n\n\n\n
            • \u5927\u8178\u304c\u3093<\/li>\n\n\n\n
            • \u80c6\u9053\u304c\u3093<\/li>\n<\/ul>\n\n\n\n

              \u8907\u6570\u306e\u304c\u3093\u7a2e\u3067\u540c\u3058\u907a\u4f1d\u5b50\u5909\u7570\u3092\u6301\u3064\u60a3\u8005\u3060\u3051\u3092\u96c6\u3081\u3001\u5206\u5b50\u6a19\u7684\u85acA\u3092\u6295\u4e0e\u3057\u3066\u594f\u52b9\u7387\u3092\u8a55\u4fa1\u3002<\/p>\n<\/div>\n\n\n\n

              \u30a2\u30f3\u30d6\u30ec\u30e9\u8a66\u9a13 (Umbrella Trial)<\/strong><\/h4>\n\n\n\n

              \u300c1\u3064\u306e\u304c\u3093\u7a2e \u00d7 \u8907\u6570\u306e\u85ac\u300d<\/strong>\u3002<\/p>\n\n\n\n

              \u7279\u5b9a\u306e\u304c\u3093\u7a2e\uff08\u4f8b\uff1a\u80ba\u304c\u3093\uff09\u306e\u4e2d\u3067\u3001\u907a\u4f1d\u5b50\u5909\u7570\u306e\u30bf\u30a4\u30d7\u5225\u306b\u7570\u306a\u308b\u85ac\u5264\u3092\u5272\u308a\u4ed8\u3051\u307e\u3059\uff08\u540c\u3058\u304c\u3093\u7a2e\u5185\u3067\u5206\u5b50\u30bf\u30a4\u30d7\u5225\u306b\u6cbb\u7642\u3092\u5206\u3051\u308b\u8003\u3048\u65b9\uff09\u3002(\u53c2\u8003\uff1a\u65e5\u672c\u88fd\u85ac\u5de5\u696d\u5354\u4f1a 4)<\/p>\n\n\n\n

              \n
              \n

              <\/span>\u4f8b\uff1a\u540c\u3058\u80ba\u304c\u3093\u3067\u3082\u3001\u907a\u4f1d\u5b50\u30bf\u30a4\u30d7\u3067\u52b9\u304f\u85ac\u306f\u7570\u306a\u308b\u304b\u3092\u691c\u8a3c\u3057\u305f\u3044<\/span><\/strong><\/p>\n\n\n\n

              \u80ba\u304c\u3093\u60a3\u8005\u3092\u691c\u67fb\u3057\u3001<\/p>\n\n\n\n

                \n
              • \u5909\u7570X \u2192 \u85acA<\/li>\n\n\n\n
              • \u5909\u7570Y \u2192 \u85acB<\/li>\n\n\n\n
              • \u5909\u7570Z \u2192 \u85acC<\/li>\n<\/ul>\n\n\n\n

                \u3068\u3044\u3046\u3088\u3046\u306b\u540c\u3058\u304c\u3093\u7a2e\u306e\u4e2d\u3067\u85ac\u3092\u5206\u3051\u3066\u52b9\u679c\u3092\u8a55\u4fa1\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

                \u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u8a66\u9a13<\/strong><\/h4>\n\n\n\n

                \u6642\u9593\u7d4c\u904e\u3068\u3068\u3082\u306b\u52b9\u679c\u306e\u306a\u3044\u6cbb\u7642\u7fa4\u3092\u9664\u5916\u3057\u3001\u65b0\u3057\u3044\u6cbb\u7642\u7fa4\u3092\u8ffd\u52a0\u3067\u304d\u308b\u300c\u7d42\u308f\u3089\u306a\u3044\u8a66\u9a13\u300d\u69cb\u9020\u3092\u6301\u3061\u307e\u3059\uff08\u8a66\u9a13\u3092\u7d99\u7d9a\u3057\u306a\u304c\u3089\u6cbb\u7642\u7fa4\u3092\u5165\u308c\u66ff\u3048\u3089\u308c\u308b\u4ed5\u7d44\u307f\uff09\u3002<\/p>\n\n\n\n

                \n

                <\/span>\u4f8b\uff1a\u65b0\u3057\u3044\u6cbb\u7642\u5019\u88dc\u304c\u6b21\u3005\u51fa\u3066\u304f\u308b\u75be\u60a3\u3067\u3001\u52b9\u7387\u3088\u304f\u52dd\u3061\u6b8b\u308a\u65b9\u5f0f\u3067\u691c\u8a3c<\/span><\/strong><\/p>\n\n\n\n

                \u5171\u901a\u306e\u6a19\u6e96\u6cbb\u7642\u3092\u5bfe\u7167\u306b\u3057\u306a\u304c\u3089<\/p>\n\n\n\n

                  \n
                • \u6709\u671b\u306a\u65b0\u85ac\u7fa4\u3092\u8ffd\u52a0<\/li>\n\n\n\n
                • \u52b9\u679c\u304c\u5f31\u3044\u7fa4\u306f\u9014\u4e2d\u3067\u7d42\u4e86<\/li>\n<\/ul>\n\n\n\n

                  \u3092\u7e70\u308a\u8fd4\u3059\u3002\u611f\u67d3\u75c7\u3084\u304c\u3093\u306a\u3069\u3067\u63a1\u7528\u3055\u308c\u308b\u8003\u3048\u65b9\u3002<\/p>\n<\/div>\n\n\n\n

                  \u30a2\u30c0\u30d7\u30c6\u30a3\u30d6\u30c7\u30b6\u30a4\u30f3 (Adaptive Design)<\/strong><\/h3>\n\n\n\n

                  \u8a66\u9a13\u9014\u4e2d\u306e\u30c7\u30fc\u30bf\uff08\u4e2d\u9593\u89e3\u6790\uff1a\u9014\u4e2d\u6642\u70b9\u3067\u884c\u3046\u52b9\u679c\u3084\u5b89\u5168\u6027\u306e\u8a55\u4fa1\uff09\u306b\u57fa\u3065\u3044\u3066\u3001\u4e8b\u524d\u306b\u8a08\u753b\u3055\u308c\u305f\u624b\u9806\u306b\u6cbf\u3063\u3066\u8a66\u9a13\u6cd5\u3092\u5909\u66f4\u3059\u308b\u30c7\u30b6\u30a4\u30f3\u3067\u3059\u3002<\/p>\n\n\n\n

                  \u30a2\u30c0\u30d7\u30c6\u30a3\u30d6\u30c7\u30b6\u30a4\u30f3<\/strong><\/div>
                  \n

                  <\/span>\u3067\u304d\u308b\u3053\u3068:<\/strong> \u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u306e\u518d\u8a2d\u8a08\u3001\u52b9\u679c\u304c\u898b\u8fbc\u3081\u306a\u3044\u7fa4\u306e\u65e9\u671f\u4e2d\u6b62\u3001\u512a\u826f\u306a\u7fa4\u3078\u306e\u5272\u4ed8\u6bd4\u7387\u306e\u5909\u66f4\u306a\u3069\u304c\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n

                  <\/span>\u6ce8\u610f\u70b9:<\/strong> \u6063\u610f\u7684\u306a\u5909\u66f4\u306f\u8a31\u3055\u308c\u307e\u305b\u3093\u3002\u30bf\u30a4\u30d7I\u30a8\u30e9\u30fc\uff08\u507d\u967d\u6027\uff1a\u672c\u5f53\u306f\u5dee\u304c\u306a\u3044\u306e\u306b\u5dee\u304c\u3042\u308b\u3068\u5224\u65ad\u3059\u308b\u8aa4\u308a\uff09\u306e\u5897\u5927\u3092\u9632\u3050\u7d71\u8a08\u7684\u306a\u8abf\u6574\u3068\u3001PMDA\u3078\u306e\u7dbf\u5bc6\u306a\u4e8b\u524d\u76f8\u8ac7\u304c\u5fc5\u9808\u3067\u3059\u3002<\/p>\n<\/div><\/div>\n\n\n\n

                  \n

                  <\/span>\u4f8b\uff1a\u82b1\u7c89\u75c7\u306e\u65b0\u85acA\u304c\u6a19\u6e96\u85acB\u3088\u308a\u52b9\u304f\u304b\u78ba\u8a8d\u3057\u305f\u3044<\/span><\/strong><\/p>\n\n\n\n

                  \u5f53\u521d\u306e\u8a08\u753b\u3067\u306f200\u4eba\u3067\u6bd4\u8f03\u3059\u308b\u8a2d\u8a08\u3002<\/p>\n\n\n\n

                  \u305f\u3060\u3057\u3001\u4e2d\u9593\u89e3\u6790\u3067\u52b9\u679c\u306f\u51fa\u3066\u3044\u305d\u3046\u3060\u304c\u4e88\u60f3\u3088\u308a\u3070\u3089\u3064\u304d\u304c\u5927\u304d\u3044\u3053\u3068\u304c\u5206\u304b\u3063\u305f\u3002<\/p>\n\n\n\n

                  \u305d\u3053\u3067\u3001\u3042\u3089\u304b\u3058\u3081\u6c7a\u3081\u3066\u304a\u3044\u305f\u6761\u4ef6\u306b\u5f93\u3063\u3066\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u3092300\u4eba\u306b\u5897\u3084\u3059\u3002<\/p>\n<\/div>\n\n\n\n

                  \u30d9\u30a4\u30ba\u6d41\u30c7\u30b6\u30a4\u30f3 (Bayesian Design)<\/strong><\/h3>\n\n\n\n

                  \u5f93\u6765\u306e\u983b\u5ea6\u8ad6\uff08P\u5024\uff1a\u5076\u7136\u306b\u3088\u308b\u7d50\u679c\u306e\u78ba\u7387\u3092\u8a55\u4fa1\u3059\u308b\u6307\u6a19\uff09\u3060\u3051\u306b\u3053\u3060\u308f\u3089\u305a\u3001\u300c\u4e8b\u5f8c\u78ba\u7387\uff08\u30c7\u30fc\u30bf\u304c\u5f97\u3089\u308c\u305f\u5f8c\u306b\u771f\u3067\u3042\u308b\u78ba\u7387\uff09\u300d\u3092\u7528\u3044\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u3059\u3002<\/p>\n\n\n\n

                  \u30d9\u30a4\u30ba\u6d41\u30c7\u30b6\u30a4\u30f3<\/strong><\/div>
                  \n

                  <\/span>\u30e1\u30ea\u30c3\u30c8:<\/strong> \u904e\u53bb\u306e\u8a66\u9a13\u30c7\u30fc\u30bf\u306a\u3069\u306e\u300c\u4e8b\u524d\u60c5\u5831\u300d\u3092\u6d3b\u7528\u3067\u304d\u308b\u305f\u3081\u3001\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u304c\u9650\u3089\u308c\u308b\u5e0c\u5c11\u75be\u60a3<\/strong>\u3084\u5c0f\u5150\u304c\u3093<\/strong>\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u306b\u304a\u3044\u3066\u52b9\u7387\u7684\u3067\u3059\u3002<\/p>\n<\/div><\/div>\n\n\n\n

                  \n

                  <\/span>\u4f8b\uff1a\u60a3\u8005\u304c\u5c11\u306a\u3044\u5e0c\u5c11\u75be\u60a3\u3067\u3001\u7121\u99c4\u306a\u304f\u8a66\u9a13\u3057\u305f\u3044<\/strong><\/span><\/span><\/strong><\/p>\n\n\n\n

                  \u904e\u53bb\u306e\u5c0f\u898f\u6a21\u7814\u7a76\u3084\u30ec\u30b8\u30b9\u30c8\u30ea\u3092\u4e8b\u524d\u60c5\u5831\u3068\u3057\u3066\u4f7f\u3044\u3001\u65b0\u3057\u3044\u8a66\u9a13\u30c7\u30fc\u30bf\u304c\u5165\u308b\u305f\u3073\u306b\u3053\u306e\u85ac\u304c\u6709\u52b9\u3067\u3042\u308b\u78ba\u7387\u3092\u66f4\u65b0\u3002<\/p>\n\n\n\n

                  \u4e00\u5b9a\u306e\u78ba\u7387\u3092\u8d85\u3048\u305f\u3089\u65e9\u671f\u306b\u6709\u52b9\u3068\u5224\u65ad\u3001\u4f4e\u3051\u308c\u3070\u65e9\u671f\u4e2d\u6b62\u3092\u691c\u8a0e\u3002<\/p>\n<\/div>\n\n\n\n

                  \u7279\u6b8a\u306a\u30b1\u30fc\u30b9\uff1a\u5e0c\u5c11\u75be\u60a3\u30fb\u5c0f\u898f\u6a21\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3<\/strong><\/h2>\n\n\n\n

                  N-of-1\u8a66\u9a13\uff08\u5358\u4e00\u53c2\u52a0\u8005\u8a66\u9a13\uff09<\/strong><\/h3>\n\n\n\n

                  \u4e00\u4eba\u306e\u60a3\u8005\u306e\u4e2d\u3067\u3001\u5b9f\u85ac\u3068\u30d7\u30e9\u30bb\u30dc\u3092\u30e9\u30f3\u30c0\u30e0\u306b\u4f55\u5ea6\u3082\u5207\u308a\u66ff\u3048\u3066\u8a55\u4fa1\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

                  N-of-1\u8a66\u9a13<\/strong>\u306e\u7279\u5fb4<\/div>
                  \n

                  \u96c6\u56e3\u5e73\u5747\u3067\u306f\u306a\u304f\u3001\u300c\u305d\u306e\u60a3\u8005\u500b\u4eba\u306b\u3068\u3063\u3066\u85ac\u304c\u52b9\u304f\u304b\u300d\u3092\u79d1\u5b66\u7684\u306b\u691c\u8a3c\u3059\u308b\u3001\u7a76\u6975\u306e\u500b\u5225\u5316\u533b\u7642\u30c7\u30b6\u30a4\u30f3\u3067\u3059\u3002<\/p>\n<\/div><\/div>\n\n\n\n

                  \n

                  <\/span>\u4f8b\uff1a\u6162\u6027\u306e\u795e\u7d4c\u75db\u3067\u201c\u3053\u306e\u60a3\u8005\u306b\u3068\u3063\u3066\u201d\u672c\u5f53\u306b\u52b9\u304f\u85ac\u3092\u77e5\u308a\u305f\u3044<\/span><\/strong><\/strong><\/span><\/span><\/strong><\/p>\n\n\n\n

                  1\u4eba\u306e\u60a3\u8005\u306b<\/p>\n\n\n\n

                    \n
                  • 1\u9031\u9593\uff1a\u85acA<\/li>\n\n\n\n
                  • 1\u9031\u9593\uff1a\u30d7\u30e9\u30bb\u30dc<\/li>\n\n\n\n
                  • 1\u9031\u9593\uff1a\u85acA<\/li>\n\n\n\n
                  • 1\u9031\u9593\uff1a\u30d7\u30e9\u30bb\u30dc<\/li>\n<\/ul>\n\n\n\n

                    \u306e\u3088\u3046\u306b\u30e9\u30f3\u30c0\u30e0\u306a\u9806\u3067\u8907\u6570\u56de\u5207\u308a\u66ff\u3048\u3001\u75db\u307f\u65e5\u8a8c\u3084\u6d3b\u52d5\u91cf\u3092\u6bd4\u8f03\u3057\u3066\u3053\u306e\u4eba\u306bA\u304c\u52b9\u304f\u304b\u3092\u5224\u65ad\u3002<\/p>\n<\/div>\n\n\n\n

                    \u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\uff08RWD\uff09\u3068\u5916\u90e8\u5bfe\u7167\u306e\u6d3b\u7528<\/strong><\/h3>\n\n\n\n

                    \u75be\u60a3\u767b\u9332\uff08\u30ec\u30b8\u30b9\u30c8\u30ea\uff1a\u60a3\u8005\u60c5\u5831\u3092\u7cfb\u7d71\u7684\u306b\u96c6\u3081\u305f\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff09\u30c7\u30fc\u30bf\u306a\u3069\u3092\u5bfe\u7167\u7fa4\uff08\u5916\u90e8\u5bfe\u7167\uff09\u3068\u3057\u3066\u5229\u7528\u3057\u3001\u5358\u7fa4\u8a66\u9a13\u306e\u7d50\u679c\u3068\u6bd4\u8f03\u3059\u308b\u624b\u6cd5\u3067\u3059\u3002\u5bfe\u7167\u7fa4\u3092\u7f6e\u304f\u3053\u3068\u304c\u56f0\u96e3\u306a\u5e0c\u5c11\u75be\u60a3\u3067\u306e\u958b\u767a\u3092\u88dc\u5b8c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

                    \n

                    <\/span>\u4f8b<\/strong>\uff1a\u60a3\u8005\u6570\u304c\u5c11\u306a\u3044\u5e0c\u5c11\u75be\u60a3\u3067\u65b0\u85acA\u306e\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3057\u305f\u3044<\/span><\/strong><\/strong><\/span><\/span><\/strong><\/p>\n\n\n\n

                    \u65b0\u85acA\u3092\u4f7f\u3046\u5358\u7fa4\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u305f\u3044\u304c\u3001\u502b\u7406\u7684\u30fb\u4eba\u6570\u7684\u306b\u300c\u30d7\u30e9\u30bb\u30dc\u7fa4\u300d\u3092\u4f5c\u308c\u306a\u3044\u3002<\/p>\n\n\n\n

                    \u305d\u3053\u3067\u3001\u904e\u53bb\u306b\u540c\u3058\u75be\u60a3\u3067\u6a19\u6e96\u6cbb\u7642\u3092\u53d7\u3051\u305f\u60a3\u8005\u306e\u30ec\u30b8\u30b9\u30c8\u30ea\uff08RWD\uff09 \u3092\u96c6\u3081\u3001\u5916\u90e8\u5bfe\u7167\u7fa4\u3068\u3057\u3066\u6bd4\u8f03\u3059\u308b\u3002<\/p>\n<\/div>\n\n\n\n

                    \u6700\u9069\u306a\u30c7\u30b6\u30a4\u30f3\u3092\u9078\u3076\u305f\u3081\u306e\u8996\u70b9<\/strong><\/h2>\n\n\n\n
                    \"\"<\/figure>\n\n\n\n

                    \u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u3092\u9078\u629e\u3059\u308b\u969b\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u8907\u6570\u306e\u5224\u65ad\u8ef8\u3092\u7dcf\u5408\u7684\u306b\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

                    \u3069\u306e\u30c7\u30b6\u30a4\u30f3\u304c\u300c\u79d1\u5b66\u7684\u306b\u59a5\u5f53\u300d\u300c\u502b\u7406\u7684\u306b\u8a31\u5bb9\u300d\u300c\u5b9f\u52d9\u7684\u306b\u6210\u7acb\u300d\u3059\u308b\u304b\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u89b3\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n

                    1. \u7814\u7a76\u76ee\u7684\uff08Research Question\uff09\u306b\u57fa\u3065\u304f\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u81e8\u5e8a\u8a66\u9a13\u306e\u4e2d\u5fc3\u3068\u306a\u308b\u554f\u3044\u306f\u4f55\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u8a66\u9a13\u76ee\u7684<\/strong><\/div>

                    \u63a2\u7d22\uff0f\u512a\u8d8a\u6027\u691c\u8a3c\uff0f\u975e\u52a3\u6027\u691c\u8a3c\u306e\u3069\u308c\u304b<\/p><\/div><\/div>

                    2<\/div>
                    \u5bfe\u8c61\u96c6\u56e3\u306e\u5b9a\u7fa9<\/strong><\/div>

                    \u75be\u60a3\u3001\u91cd\u75c7\u5ea6\u3001\u6cbb\u7642\u30e9\u30a4\u30f3\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc<\/p><\/div><\/div>

                    3<\/div>
                    \u4e3b\u8981\u8a55\u4fa1\u9805\u76ee<\/strong><\/div>

                    ORR\u3001PFS\u3001OS\u3001\u75c7\u72b6\u6539\u5584\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u5909\u5316\u306a\u3069<\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 \u7814\u7a76\u306e\u76ee\u7684\u3068\u8a55\u4fa1\u9805\u76ee\u304c\u3001\u9069\u5207\u306a\u30c7\u30b6\u30a4\u30f3\u3092\u9078\u3076\u201c\u6839\u672c\u6761\u4ef6\u201d\u3068\u306a\u308b\u3002<\/span><\/strong><\/p>\n\n\n\n

                    2. \u75be\u60a3\u3068\u4ecb\u5165\u7279\u6027\u306e\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u30c7\u30b6\u30a4\u30f3\u304c\u6210\u7acb\u3059\u308b\u305f\u3081\u306e\u751f\u7269\u5b66\u7684\u30fb\u81e8\u5e8a\u7684\u5236\u7d04\u306f\u4f55\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u75be\u60a3\u306e\u6027\u8cea<\/strong><\/div>

                    \u6025\u6027\uff0f\u6162\u6027\u3001\u9032\u884c\u6027\u304b\u5b89\u5b9a\u6027\u304b<\/p><\/div><\/div>

                    2<\/div>
                    \u52b9\u679c\u306e\u6027\u8cea<\/strong><\/div>

                    \u53ef\u9006\u7684\u304b\u3001\u6301\u3061\u8d8a\u3057\u52b9\u679c\uff08carryover\uff09\u304c\u751f\u3058\u308b\u304b<\/p><\/div><\/div>

                    3<\/div>
                    \u6a19\u6e96\u6cbb\u7642\u306e\u6709\u7121<\/strong><\/div>

                    <\/p><\/div><\/div>

                    4<\/div>
                    \u30d7\u30e9\u30bb\u30dc\u5bfe\u7167\u304c\u502b\u7406\u7684\u306b\u8a31\u5bb9\u3055\u308c\u308b\u304b<\/strong><\/div>

                    <\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 \u30af\u30ed\u30b9\u30aa\u30fc\u30d0\u30fc\u304c\u53ef\u80fd\u304b\u3001\u5358\u7fa4\u8a66\u9a13\u304c\u8a31\u3055\u308c\u308b\u304b\u3001\u5bfe\u7167\u7fa4\u304c\u5fc5\u9808\u304b\u304c\u6c7a\u307e\u308b\u3002<\/span><\/strong><\/p>\n\n\n\n

                    3. \u5b9f\u884c\u53ef\u80fd\u6027\uff08Feasibility\uff09\u306e\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u7406\u8ad6\u4e0a\u53ef\u80fd\u3067\u3082\u3001\u5b9f\u52d9\u3068\u3057\u3066\u6210\u7acb\u3059\u308b\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u4e88\u6e2c\u75c7\u4f8b\u6570<\/strong><\/div>

                    <\/p><\/div><\/div>

                    2<\/div>
                    \u671f\u9593\u30fb\u4e88\u7b97\u30fb\u904b\u7528\u96e3\u6613\u5ea6<\/strong><\/div>

                    <\/p><\/div><\/div>

                    3<\/div>
                    \u5b9f\u65bd\u65bd\u8a2d\u306e\u80fd\u529b\u30fb\u6cbb\u9a13\u4f53\u5236<\/strong><\/div>

                    <\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 RCT\u304c\u3067\u304d\u308b\u75c7\u4f8b\u6570\u304b\uff0f\u5c0f\u898f\u6a21\u30c7\u30b6\u30a4\u30f3\u304c\u5fc5\u8981\u304b\u306e\u73fe\u5b9f\u7684\u306a\u5224\u65ad\u57fa\u76e4\u3002<\/span><\/strong><\/p>\n\n\n\n

                    4. \u5bfe\u7167\u7fa4\u8a2d\u5b9a\u306e\u59a5\u5f53\u6027\u3092\u8a55\u4fa1\u3059\u308b\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u5bfe\u7167\u7fa4\u3092\u7f6e\u304f\u3053\u3068\u304c\u53ef\u80fd\u304b\uff0f\u502b\u7406\u7684\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u4e26\u884c\u7fa4\u9593\u306eRCT\u3092\u5b9f\u65bd\u3067\u304d\u308b\u6761\u4ef6\u304c\u63c3\u3063\u3066\u3044\u308b\u304b<\/strong><\/div>

                    <\/p><\/div><\/div>

                    2<\/div>
                    \u5bfe\u7167\u7fa4\u304c\u4e0d\u53ef\u80fd\u30fb\u4e0d\u502b\u7406\u306a\u5834\u5408\u306b\u5358\u7fa4\u8a66\u9a13\u3092\u8003\u616e\u3059\u3079\u304d\u304b<\/strong><\/div>

                    <\/p><\/div><\/div>

                    3<\/div>
                    \u5916\u90e8\u5bfe\u7167\uff08RWD\u30fb\u6b74\u53f2\u5bfe\u7167\uff09\u3092\u4f7f\u3046\u5834\u5408\u306e\u540c\u7b49\u6027\u3084\u30d0\u30a4\u30a2\u30b9\u7ba1\u7406\u306f\u53ef\u80fd\u304b<\/strong><\/div>

                    <\/p><\/div><\/div>

                    4<\/div>
                    \u65e9\u671f\u4e2d\u6b62\uff08futility\/efficacy\uff09\u30eb\u30fc\u30eb\u306a\u3069\u304c\u5fc5\u8981\u304b<\/strong><\/div>

                    <\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 \u5bfe\u7167\u7fa4\u306e\u6709\u7121\u306f\u3001\u79d1\u5b66\u7684\u59a5\u5f53\u6027\u3068\u502b\u7406\u6027\u306e\u4e21\u5074\u9762\u304b\u3089\u8a55\u4fa1\u3055\u308c\u308b\u4e3b\u8981\u5224\u65ad\u8ef8\u3002<\/span><\/strong><\/p>\n\n\n\n

                    5. \u540c\u4e00\u88ab\u9a13\u8005\u5185\u6bd4\u8f03\u306e\u9069\u5426\uff08\u30af\u30ed\u30b9\u30aa\u30fc\u30d0\u30fc\uff09\u306e\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u30af\u30ed\u30b9\u30aa\u30fc\u30d0\u30fc\u304c\u6210\u7acb\u3059\u308b\u75be\u60a3\u30fb\u85ac\u5264\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u6301\u3061\u8d8a\u3057\u52b9\u679c\u304c\u5c0f\u3055\u3044<\/strong><\/div>

                    <\/p><\/div><\/div>

                    2<\/div>
                    \u75c7\u72b6\u3084\u75c5\u52e2\u304c\u77ed\u671f\u306b\u5b89\u5b9a\u3057\u3066\u3044\u308b<\/strong><\/div>

                    <\/p><\/div><\/div>

                    3<\/div>
                    Washout\u671f\u9593\u304c\u5341\u5206\u53d6\u308c\u308b<\/strong><\/div>

                    <\/p><\/div><\/div>

                    4<\/div>
                    \u6025\u6027\u75be\u60a3\u3084\u4e0d\u53ef\u9006\u7684\u6cbb\u7642\u3067\u306f\u6210\u7acb\u3057\u306a\u3044<\/strong><\/div>

                    <\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 \u7528\u91cf\u53cd\u5fdc\u3084\u77ed\u671f\u52b9\u679c\u3092\u898b\u308b\u5834\u5408\u306b\u6709\u52b9\u3060\u304c\u3001\u9069\u5fdc\u6761\u4ef6\u304c\u53b3\u3057\u3044\u30c7\u30b6\u30a4\u30f3\u3002<\/span><\/strong><\/p>\n\n\n\n

                    6. \u7cbe\u5bc6\u533b\u7642\uff08\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\uff09\u9069\u5fdc\u306e\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u907a\u4f1d\u5b50\u5909\u7570\u3084\u5206\u5b50\u30b5\u30d6\u30bf\u30a4\u30d7\u304c\u8a66\u9a13\u69cb\u9020\u306b\u5f71\u97ff\u3059\u308b\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u7279\u5b9a\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3067\u88ab\u9a13\u8005\u304c\u5c64\u5225\u5316\u3055\u308c\u308b<\/strong><\/div>

                    <\/p><\/div><\/div>

                    2<\/div>
                    1\u3064\u306e\u85ac\u5264\u3092\u8907\u6570\u75be\u60a3\u306b\u6a2a\u65ad\u2192\u30d0\u30b9\u30b1\u30c3\u30c8<\/strong><\/div>

                    <\/p><\/div><\/div>

                    3<\/div>
                    1\u75be\u60a3\u306e\u4e2d\u3067\u8907\u6570\u6a19\u7684\u6cbb\u7642\u3092\u6bd4\u8f03\u2192\u30a2\u30f3\u30d6\u30ec\u30e9<\/strong><\/div>

                    <\/p><\/div><\/div>

                    4<\/div>
                    \u7fa4\u8ffd\u52a0\u30fb\u5165\u66ff\u3092\u7d99\u7d9a\u7684\u306b\u884c\u3044\u305f\u3044\u2192\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/strong><\/div>

                    <\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 \u30de\u30b9\u30bf\u30fc\u30d7\u30ed\u30c8\u30b3\u30eb\u63a1\u7528\u306e\u53ef\u5426\u3092\u6c7a\u3081\u308b\u4e3b\u8981\u5224\u65ad\u8ef8\u3002<\/span><\/strong><\/p>\n\n\n\n

                    7. \u7d71\u8a08\u7684\u59a5\u5f53\u6027\u306e\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u5c02\u9580\u5bb6\u306e\u8996\u70b9\u3067\u79d1\u5b66\u7684\u6210\u7acb\u6027\u3092\u62c5\u4fdd\u3067\u304d\u308b\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3068\u89e3\u6790\u624b\u6cd5\u306e\u6574\u5408\u6027<\/strong><\/div>

                    <\/p><\/div><\/div>

                    2<\/div>
                    \u5fc5\u8981\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u306e\u59a5\u5f53\u6027<\/strong><\/div>

                    <\/p><\/div><\/div>

                    3<\/div>
                    \u4e2d\u9593\u89e3\u6790\u30fb\u30a2\u30c0\u30d7\u30c6\u30a3\u30d6\u624b\u6cd5\u306e\u8aa4\u5dee\uff08Type I error\uff09\u7ba1\u7406<\/strong><\/div>

                    <\/p><\/div><\/div>

                    4<\/div>
                    \u30d0\u30a4\u30a2\u30b9\u30fb\u4ea4\u7d61\u56e0\u5b50\u3078\u306e\u7d71\u8a08\u7684\u5bfe\u51e6<\/strong><\/div>

                    <\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 \u30c7\u30b6\u30a4\u30f3\u306e\u201c\u79d1\u5b66\u7684\u6210\u7acb\u6027\u201d\u3092\u4fdd\u8a3c\u3059\u308b\u4e0d\u53ef\u6b20\u306e\u8ef8\u3002<\/span><\/strong><\/p>\n\n\n\n

                    8. \u898f\u5236\u5f53\u5c40\uff08PMDA\u7b49\uff09\u3068\u306e\u6574\u5408\u6027\u5224\u65ad\u8ef8<\/strong><\/h3>\n\n\n\n

                    \u627f\u8a8d\u6226\u7565\u30fb\u502b\u7406\u6027\u306b\u7167\u3089\u3057\u3066\u53d7\u5bb9\u6027\u304c\u3042\u308b\u304b\uff1f<\/p>\n\n\n\n

                    1<\/div>
                    \u975e\u6a19\u6e96\u30c7\u30b6\u30a4\u30f3\u306e\u59a5\u5f53\u6027\uff08\u5358\u7fa4\uff0b\u5916\u90e8\u5bfe\u7167\u3001\u30de\u30b9\u30bf\u30fc\u30d7\u30ed\u30c8\u30b3\u30eb\u7b49\uff09<\/strong><\/div>

                    <\/p><\/div><\/div>

                    2<\/div>
                    \u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306e\u53d7\u5bb9\u6027<\/strong><\/div>

                    <\/p><\/div><\/div>

                    3<\/div>
                    \u627f\u8a8d\u6226\u7565\u30fb\u958b\u767a\u30d5\u30a7\u30fc\u30ba\u5168\u4f53\u3067\u306e\u6574\u5408<\/strong><\/div>

                    <\/p><\/div><\/div><\/div><\/div>\n\n\n\n

                    \u2192 \u5b9f\u969b\u306b\u627f\u8a8d\u7533\u8acb\u3092\u898b\u636e\u3048\u308b\u5834\u5408\u306f\u78ba\u8a8d\u3059\u3079\u304d\u8ef8\u3002<\/span><\/strong><\/p>\n\n\n\n

                    \u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306b\u95a2\u3059\u308b\u3088\u304f\u3042\u308b\u8cea\u554f (FAQ)<\/strong><\/h2>\n\n\n\n
                    \n
                    Q<\/div>
                    \u30a8\u30d3\u30c7\u30f3\u30b9\u30ec\u30d9\u30eb\u304c\u6700\u3082\u9ad8\u3044\u7814\u7a76\u30c7\u30b6\u30a4\u30f3\u306f\uff1f
                    <\/strong><\/div><\/dt>
                    A<\/div>
                    \n

                    \u500b\u5225\u306e\u81e8\u5e8a\u7814\u7a76\u3067\u306f\u300c\u30e9\u30f3\u30c0\u30e0\u5316\u6bd4\u8f03\u8a66\u9a13\uff08RCT\uff09\u300d\u304c\u6700\u3082\u4e0a\u4f4d\u3067\u3059\u3002\u3055\u3089\u306b\u8907\u6570\u306eRCT\u3092\u7d71\u5408\u30fb\u89e3\u6790\u3057\u305f\u300c\u30b7\u30b9\u30c6\u30de\u30c6\u30a3\u30c3\u30af\u30ec\u30d3\u30e5\u30fc\uff08\u30e1\u30bf\u89e3\u6790\uff1a\u8907\u6570\u7814\u7a76\u3092\u7d71\u5408\u3057\u3066\u7d50\u8ad6\u306e\u7cbe\u5ea6\u3092\u9ad8\u3081\u308b\u65b9\u6cd5\uff09\u300d\u304c\u305d\u306e\u4e0a\u4f4d\u306b\u4f4d\u7f6e\u3057\u307e\u3059\u3002<\/p>\n<\/div><\/dd><\/dl>\n\n\n\n

                    Q<\/div>
                    POC\uff08Proof of Concept\uff09\u3068\u306f\u533b\u7642\u7528\u8a9e\u3067\u4f55\u3067\u3059\u304b\uff1f
                    <\/strong><\/div><\/dt>
                    A<\/div>
                    \n

                    \u300c\u6982\u5ff5\u5b9f\u8a3c\u300d\u3067\u3059\u3002\u4e3b\u306b\u7b2cII\u76f8\u8a66\u9a13\u306a\u3069\u3067\u3001\u65b0\u85ac\u306e\u52b9\u679c\u304c\u52d5\u7269\u3060\u3051\u3067\u306a\u304f\u30d2\u30c8\u3067\u3082\u671f\u5f85\u901a\u308a\u306b\u767a\u63ee\u3055\u308c\u308b\u304b\u3092\u78ba\u8a8d\u3059\u308b\u91cd\u8981\u306a\u6bb5\u968e\u3092\u6307\u3057\u307e\u3059\u3002<\/p>\n<\/div><\/dd><\/dl>\n\n\n\n

                    Q<\/div>
                    \u6cbb\u9a13\u306e\u5931\u6557\u7387\u3092\u4e0b\u3052\u308b\u305f\u3081\u306e\u30c7\u30b6\u30a4\u30f3\u4e0a\u306e\u5de5\u592b\u306f\uff1f
                    <\/strong><\/div><\/dt>
                    A<\/div>
                    \n

                    \u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\uff08\u6cbb\u7642\u52b9\u679c\u3084\u75c5\u614b\u3092\u53cd\u6620\u3059\u308b\u6e2c\u5b9a\u6307\u6a19\uff09\u3092\u6d3b\u7528\u3057\u3066\u52b9\u679c\u304c\u51fa\u3084\u3059\u3044\u60a3\u8005\u5c64\u3092\u7d5e\u308a\u8fbc\u3080\u3053\u3068\u3084\u3001\u7121\u76ca\u306a\u5834\u5408\u306b\u65e9\u671f\u4e2d\u6b62\u3057\u3066\u30ea\u30bd\u30fc\u30b9\u3092\u6700\u9069\u5316\u3067\u304d\u308b\u300c\u30a2\u30c0\u30d7\u30c6\u30a3\u30d6\u30c7\u30b6\u30a4\u30f3\u300d\u306e\u5c0e\u5165\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n<\/div><\/dd><\/dl>\n\n\n\n

                    Q<\/div>
                    Q. \u30a2\u30f3\u30d6\u30ec\u30e9\u8a66\u9a13\u3068\u30d0\u30b9\u30b1\u30c3\u30c8\u8a66\u9a13\u306e\u9055\u3044\u3092\u4e00\u8a00\u3067\u8a00\u3046\u3068\uff1f
                    <\/strong><\/div><\/dt>
                    A<\/div>
                    \n

                    \u300c\u540c\u3058\u75c5\u6c17\u30fb\u9055\u3046\u85ac\uff1d\u30a2\u30f3\u30d6\u30ec\u30e9\u300d\u3001\u300c\u9055\u3046\u75c5\u6c17\u30fb\u540c\u3058\u85ac\uff1d\u30d0\u30b9\u30b1\u30c3\u30c8\u300d\u3067\u3059\u3002<\/p>\n<\/div><\/dd><\/dl>\n<\/div>\n\n\n\n

                    \u307e\u3068\u3081<\/strong><\/h2>\n\n\n\n

                    \u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306f\u3001\u79d1\u5b66\u30fb\u502b\u7406\u30fb\u7d71\u8a08\u30fb\u898f\u5236\u304c\u8907\u96d1\u306b\u7d61\u307f\u5408\u3046\u30d1\u30ba\u30eb\u3067\u3059\u3002<\/p>\n\n\n\n

                    \u8fd1\u5e74\u3067\u306f\u30d9\u30a4\u30ba\u6d41\u3084\u30a2\u30c0\u30d7\u30c6\u30a3\u30d6\u30c7\u30b6\u30a4\u30f3\u306a\u3069\u9078\u629e\u80a2\u304c\u5897\u3048\u3001\u3088\u308a\u9ad8\u5ea6\u306a\u5c02\u9580\u6027\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

                    \u672c\u8a18\u4e8b\u3067\u5f97\u305f\u77e5\u8b58\u3092\u30d9\u30fc\u30b9\u306b\u3057\u3064\u3064\u3001\u5b9f\u969b\u306e\u8a08\u753b\u6bb5\u968e\u3067\u306f\u5fc5\u305a\u7d71\u8a08\u5c02\u9580\u5bb6<\/strong>\u3084PMDA<\/strong>\u3068\u65e9\u671f\u304b\u3089\u76f8\u8ac7\u3092\u884c\u3046\u3053\u3068\u304c\u3001\u8a66\u9a13\u3092\u6210\u529f\u306b\u5c0e\u304f\u6700\u5927\u306e\u8fd1\u9053\u3067\u3059\u3002<\/p>\n\n\n\n

                    \u53c2\u8003\u8cc7\u6599\u30fb\u6587\u732e\u4e00\u89a7<\/strong><\/p>\n\n\n\n

                    1.PMDA https:\/\/www.pmda.go.jp\/files\/000156372.pdf
                    2.PMDA https:\/\/www.pmda.go.jp\/int-activities\/int-harmony\/ich\/0076.html
                    3.PMDA https:\/\/www.pmda.go.jp\/files\/000269222.pdf
                    4.\u65e5\u672c\u88fd\u85ac\u5de5\u696d\u5354\u4f1a https:\/\/www.jpma.or.jp\/information\/evaluation\/symposium\/jtrngf0000001cap-att\/DS_202302_masterpc.pdf
                    5.\u65e5\u672c\u88fd\u85ac\u5de5\u696d\u5354\u4f1a https:\/\/www.jpma.or.jp\/information\/evaluation\/symposium\/jtrngf0000001cap-att\/DS_202302_hirakawa1.pdf
                    6.\u6771\u4eac\u5927\u5b66 https:\/\/biostatistics.m.u-tokyo.ac.jp\/wp-content\/uploads\/2023\/03\/49-206603.pdf<\/p>\n","protected":false},"excerpt":{"rendered":"

                    \u300c\u3069\u306e\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u304c\u81ea\u5206\u305f\u3061\u306e\u7814\u7a76\u306b\u6700\u9069\u304b\u308f\u304b\u3089\u306a\u3044\u300d\u3002 \u591a\u304f\u306e\u533b\u7642\u5f93\u4e8b\u8005\u3084\u958b\u767a\u62c5\u5f53\u8005\u304c\u3001\u3053\u306e\u58c1\u306b\u76f4\u9762\u3057\u307e\u3059\u3002 \u9069\u5207\u306a\u30c7\u30b6\u30a4\u30f3\u306a\u3057\u306b\u3001\u4fe1\u983c\u3067\u304d\u308b\u30c7\u30fc\u30bf\u306f\u751f\u307e\u308c\u307e\u305b\u3093\u3002 \u672c\u8a18\u4e8b\u3067\u306f\u3001\u30e9\u30f3\u30c0\u30e0\u5316\u6bd4\u8f03\u8a66\u9a13\uff08RCT\uff1a\u53c2\u52a0\u8005\u3092\u30e9\u30f3 […]<\/p>\n","protected":false},"author":1,"featured_media":3964,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[90],"tags":[],"class_list":["post-3942","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-for-companies"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/posts\/3942","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/comments?post=3942"}],"version-history":[{"count":13,"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/posts\/3942\/revisions"}],"predecessor-version":[{"id":3985,"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/posts\/3942\/revisions\/3985"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/media\/3964"}],"wp:attachment":[{"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/media?parent=3942"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/categories?post=3942"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/chiken-japan.co.jp\/blog\/wp-json\/wp\/v2\/tags?post=3942"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}