{"id":4565,"date":"2024-01-30T08:29:00","date_gmt":"2024-01-29T23:29:00","guid":{"rendered":"https:\/\/www.crimsonjapan.co.jp\/blog\/?p=4565"},"modified":"2024-03-27T16:32:48","modified_gmt":"2024-03-27T07:32:48","slug":"why-clinical-trial-translation-is-vital-to-global-healthcare","status":"publish","type":"post","link":"https:\/\/www.crimsonjapan.co.jp\/blog\/why-clinical-trial-translation-is-vital-to-global-healthcare\/","title":{"rendered":"\u6cbb\u9a13\u7ffb\u8a33\u304c\u4e16\u754c\u4e2d\u306e\u533b\u7642\u73fe\u5834\u306b\u4e0d\u53ef\u6b20\u306a\u7406\u7531"},"content":{"rendered":"\n

\u8fd1\u5e74\u3001\u6cbb\u9a13\u3092\u53d6\u308a\u5dfb\u304f\u74b0\u5883\u306f\u5927\u304d\u304f\u9032\u5316\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u7814\u7a76\u7d50\u679c\u304c\u5e45\u5e83\u304f\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u3001\u4e16\u754c\u5404\u5730\u3067\u306e\u6cbb\u9a13\u306e\u5b9f\u65bd\u304c\u307e\u3059\u307e\u3059\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u304d\u307e\u3057\u305f\u3002\u306a\u305c\u306a\u3089\u3057\u3063\u304b\u308a\u3068\u3057\u305f\u7814\u7a76\u7d50\u679c\u306e\u305f\u3081\u306b\u306f\u3001\u591a\u304f\u306e\u30c7\u30fc\u30bf\u304c\u4e0d\u53ef\u6b20\u3060\u304b\u3089\u3067\u3059\u3002<\/p>\n\n\n\n

\u6cbb\u9a13\u304c\u4e16\u754c\u5404\u5730\u3067\u884c\u308f\u308c\u308b\u3088\u3046\u306b\u306a\u308b\u306b\u3064\u308c\u3066\u3001\u6cbb\u9a13\u306e\u7d50\u679c\u3092\u8a18\u9332\u3057\u4f1d\u3048\u308b\u305f\u3081\u306b\u95a2\u9023\u6587\u66f8\u3092\u7ffb\u8a33\u3059\u308b\u91cd\u8981\u6027\u3082\u5897\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u6cbb\u9a13\u7ffb\u8a33\u306e\u5fc5\u8981\u6027\u306b\u3064\u3044\u3066\u3001\u69d8\u3005\u306a\u5074\u9762\u304b\u3089\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u4e16\u754c\u306b\u5e83\u304c\u308b\u6cbb\u9a13:<\/strong> \u6982\u8981<\/strong><\/h2>\n\n\n\n

\u6cbb\u9a13\u306f\u3001\u9577\u304d\u306b\u308f\u305f\u3063\u3066\u533b\u5b66\u306e\u9032\u6b69\u306e\u57fa\u790e\u3067\u3042\u308a\u3001\u65b0\u3057\u3044\u6cbb\u7642\u6cd5\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u660e\u3089\u304b\u306b\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u8fd1\u5e74\u3001\u6cbb\u9a13\u306e\u72b6\u6cc1\u306f\u5927\u304d\u304f\u5909\u5316\u3057\u3066\u304a\u308a\u3001\u4e16\u754c\u4e2d\u3067\u6cbb\u9a13\u3092\u884c\u3046\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u5909\u5316\u306b\u3088\u308a\u3001\u6cbb\u9a13\u7ffb\u8a33\u306e\u91cd\u8981\u6027\u304c\u6d6e\u304d\u5f6b\u308a\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u6cbb\u9a13\u6587\u66f8\u306e\u7ffb\u8a33\u306f\u3001\u6cbb\u9a13\u306e\u6210\u679c\u3068\u4fe1\u983c\u6027\u3092\u793a\u3059\u4e0a\u3067\u3001\u304d\u308f\u3081\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3059\u306e\u3067\u3059\u3002<\/p>\n\n\n\n

\u6cbb\u9a13\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u5316\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3001\u591a\u8a00\u8a9e\u306b\u5bfe\u5fdc\u3059\u308b\u5fc5\u8981\u6027\u3082\u9ad8\u307e\u3063\u3066\u3044\u307e\u3059\u3002\u88fd\u85ac\u4f1a\u793e\u3084\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u4f01\u696d\u306f\u3001\u591a\u69d8\u306a\u60a3\u8005\u306b\u5bfe\u5fdc\u3059\u308b\u6cbb\u7642\u6cd5\u3092\u958b\u767a\u3057\u3088\u3046\u3068\u52aa\u3081\u3066\u304a\u308a\u3001\u4e16\u754c\u898f\u6a21\u3067\u6cbb\u9a13\u3092\u884c\u3046\u610f\u7fa9\u306f\u660e\u3089\u304b\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u4e16\u754c\u5404\u5730\u3078\u306e\u6cbb\u9a13\u306e\u62e1\u5927\u306f\u3001\u7ffb\u8a33\u306b\u95a2\u3059\u308b\u8ab2\u984c\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u6cbb\u9a13\u7ffb\u8a33\u306e\u5fc5\u8981\u6027<\/strong><\/h2>\n\n\n\n
    \n
  1. \u30c7\u30fc\u30bf\u306e\u7cbe\u5ea6\u3068\u4fe1\u983c\u6027<\/strong>: \u8a00\u8449\u306e\u58c1\u306f\u3001\u6cbb\u9a13\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u3055\u3068\u4fe1\u983c\u6027\u306b\u5927\u304d\u304f\u5f71\u97ff\u3057\u307e\u3059\u3002\u8a00\u8a9e\u306e\u9055\u3044\u306b\u3088\u308a\u3001\u6cbb\u9a13\u306b\u95a2\u3059\u308b\u8cc7\u6599\u304c\u8aa4\u3063\u3066\u89e3\u91c8\u3055\u308c\u3001\u6cbb\u9a13\u306e\u76ee\u7684\u3001\u624b\u9806\u3001\u5371\u967a\u6027\u306b\u3064\u3044\u3066\u8aa4\u89e3\u304c\u751f\u3058\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n
  2. \u610f\u5473\u304c\u8aa4\u3063\u3066\u4f1d\u308f\u308b\u5371\u967a\u6027<\/strong>: \u8a00\u8a9e\u306e\u58c1\u306f\u3001\u610f\u5473\u304c\u8aa4\u3063\u3066\u4f1d\u308f\u308b\u5371\u967a\u3092\u3082\u305f\u3089\u3057\u3001\u6cbb\u9a13\u306b\u304a\u3051\u308b\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u304c\u4e0d\u6b63\u78ba\u306b\u306a\u308b\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n
  3. \u6cbb\u9a13\u53c2\u52a0\u8005\u306e\u52df\u96c6:<\/strong> \u6cbb\u9a13\u3092\u898f\u5236\u3059\u308b\u7c73\u56fd\u306e\u6cd5\u5f8b<\/a>\u306f\u3001\u88ab\u9a13\u8005\u306e\u4fdd\u8b77\u3092\u660e\u78ba\u306b\u7fa9\u52d9\u3065\u3051\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6cd5\u5f8b\u306f\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u3001\u88ab\u9a13\u8005\u304c\u7406\u89e3\u3067\u304d\u308b\u8a00\u8a9e\u3067\u63d0\u793a\u3059\u308b\u3088\u3046\u6c42\u3081\u3066\u3044\u308b\u306e\u3067\u3059\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u6587\u66f8\u5316\u3082\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/li>\n\n\n\n
  4. \u79d1\u5b66\u7684\u306a\u6b63\u3057\u3055:<\/strong> \u8a00\u8a9e\u306e\u58c1\u306b\u5bfe\u51e6\u3059\u308b\u3053\u3068\u306f\u3001\u6cbb\u9a13\u53c2\u52a0\u8005\u306e\u305f\u3081\u3060\u3051\u3067\u306a\u304f\u3001\u6cbb\u9a13\u7d50\u679c\u306e\u79d1\u5b66\u7684\u306a\u6b63\u3057\u3055\u306b\u3082\u5fc5\u8981\u3067\u3059\u3002<\/li>\n<\/ol>\n\n\n\n

    \u898f\u5236\u306e\u73fe\u72b6<\/strong><\/h2>\n\n\n\n

    \u4e16\u754c\u5404\u56fd\u306e\u898f\u5236\u6a5f\u95a2\u306f\u6cbb\u9a13\u3068\u305d\u306e\u7ffb\u8a33\u306e\u91cd\u8981\u6027\u304b\u3089\u3001\u95a2\u9023\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5236\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001{\u6cbb\u9a13\u7ffb\u8a33<\/a>\u3068\u3001\u6cbb\u9a13\u306b\u95a2\u9023\u3059\u308b\u8cc7\u6599\u3092\u30ed\u30fc\u30ab\u30e9\u30a4\u30ba\u3059\u308b\u3053\u3068\u306b\u3064\u3044\u3066\u3001\u5177\u4f53\u7684\u306a\u8981\u4ef6\u306e\u6982\u8981\u3092\u793a\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u63d0\u793a\u3055\u308c\u305f\u60c5\u5831\u3092\u6cbb\u9a13\u53c2\u52a0\u8005\u5168\u54e1\u304c\u5145\u5206\u306b\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u304c\u3001\u3053\u308c\u3089\u306e\u898f\u5236\u67a0\u7d44\u307f\u306e\u57fa\u672c\u539f\u5247\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

    \u7ffb\u8a33\u3092\u63a8\u9032\u3057\u3066\u3044\u308b\u898f\u5236\u6a5f\u95a2\u306e\u4f8b<\/strong><\/h2>\n\n\n\n

    \u5148\u307b\u3069\u3082\u304a\u4f1d\u3048\u3057\u305f\u901a\u308a\u3001\u4e16\u754c\u5404\u56fd\u306e\u898f\u5236\u6a5f\u95a2\u306f\u3001\u6cbb\u9a13\u3084\u533b\u85ac\u54c1\u306e\u6dfb\u4ed8\u6587\u66f8\u306a\u3069\u3001\u533b\u7642\u306e\u69d8\u3005\u306a\u9762\u306b\u304a\u3051\u308b\u7ffb\u8a33\u3092\u91cd\u8981\u8996\u3057\u3066\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u3001\u7ffb\u8a33\u3092\u63a8\u9032\u3057\u3066\u3044\u308b\u898f\u5236\u6a5f\u95a2\u306e\u4f8b\u3092\u6319\u3052\u3066\u3044\u304d\u307e\u3059\u3002<\/p>\n\n\n\n

      \n
    1. \u6b27\u5dde\u533b\u85ac\u54c1\u5e81 (European Medicines Agency, EMA): <\/strong>\u6b27\u5dde\u9023\u5408\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u306e\u8a55\u4fa1\u3068\u76e3\u7763\u3092\u62c5\u5f53\u3059\u308b\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\u306f\u3001\u8a55\u4fa1\u306e\u904e\u7a0b\u306b\u304a\u3044\u3066\u7ffb\u8a33\u3092\u91cd\u8996\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\u306f\u3001\u88fd\u85ac\u696d\u754c\u5411\u3051\u306b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u767a\u8868\u3002\u540c\u5e81\u306f\u3001\u4e3b\u8981\u8a00\u8a9e\u3068\u3057\u3066\u82f1\u8a9e\u3067\u306e\u6587\u66f8\u63d0\u51fa\u3092\u5968\u52b1\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u6b27\u5dde\u9023\u5408\u52a0\u76df\u56fd\u5185\u306e\u8a00\u8a9e\u3078\u306e\u7ffb\u8a33\u3082\u91cd\u8996\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n\n\n\n
    2. \u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40 (Food and Drug Administration, FDA):<\/strong> \u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u306f\u3001\u533b\u85ac\u54c1\u306e\u6dfb\u4ed8\u6587\u66f8\u306b\u304a\u3044\u3066\u660e\u78ba\u306b\u5185\u5bb9\u3092\u4f1d\u3048\u308b\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u8aac\u3044\u3066\u3044\u307e\u3059\u3002\u6dfb\u4ed8\u6587\u66f8\u306e\u4e3b\u8981\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3059\u304c\u3001\u540c\u5c40\u306f\u3001\u52b9\u80fd\u30fb\u52b9\u679c\u3001\u7528\u6cd5\u30fb\u7528\u91cf\u3001\u526f\u4f5c\u7528\u3068\u3044\u3063\u305f\u7279\u5b9a\u306e\u60c5\u5831\u306b\u306f\u7ffb\u8a33\u3092\u63d0\u4f9b\u3059\u308b\u3088\u3046\u5404\u4f01\u696d\u306b\u5968\u52b1\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u591a\u69d8\u306a\u4eba\u3005\u304c\u533b\u7642\u60c5\u5831\u3092\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3068\u3044\u3046\u540c\u5c40\u306e\u4f7f\u547d\u306b\u6cbf\u3063\u305f\u3082\u306e\u3067\u3059\u3002<\/li>\n\n\n\n
    3. \u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u85ac\u54c1\u30fb\u533b\u85ac\u54c1\u884c\u653f\u5c40 (Therapeutic Goods Administration, TGA):<\/strong> \u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306e\u85ac\u54c1\u30fb\u533b\u85ac\u54c1\u884c\u653f\u5c40\u306f\u3001\u56fd\u6c11\u306e\u591a\u6587\u5316\u6027\u304b\u3089\u3001\u533b\u85ac\u54c1\u306e\u30e9\u30d9\u30eb\u3067\u306f\u91cd\u8981\u306a\u60c5\u5831\u3092\u7ffb\u8a33\u3057\u3066\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3059\u308b\u3088\u3046\u5404\u4f01\u696d\u306b\u9023\u7d61\u3057\u3066\u3044\u307e\u3059\u3002\u56fd\u6c11\u306e\u69d8\u3005\u306a\u6587\u5316\u3084\u8a00\u8a9e\u3092\u8003\u616e\u3057\u3066\u3001\u60c5\u5831\u306e\u7ffb\u8a33\u306b\u3064\u3044\u3066\u306f\u3001\u540c\u5c40\u304c\u696d\u754c\u95a2\u4fc2\u8005\u3092\u6307\u5c0e\u3057\u3066\u3044\u308b\u3088\u3046\u3067\u3059\u3002<\/li>\n<\/ol>\n\n\n\n

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

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      \u8fd1\u5e74\u3001\u6cbb\u9a13\u3092\u53d6\u308a\u5dfb\u304f\u74b0\u5883\u306f\u5927\u304d\u304f\u9032\u5316\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u7814\u7a76\u7d50\u679c\u304c\u5e45\u5e83\u304f\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u3001\u4e16\u754c\u5404\u5730\u3067\u306e\u6cbb\u9a13\u306e\u5b9f\u65bd\u304c\u307e\u3059\u307e\u3059\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u304d\u307e\u3057\u305f\u3002\u306a\u305c\u306a\u3089\u3057\u3063\u304b\u308a\u3068\u3057\u305f\u7814\u7a76\u7d50\u679c\u306e\u305f\u3081\u306b\u306f\u3001\u591a\u304f\u306e\u30c7\u30fc\u30bf\u304c\u4e0d\u53ef\u6b20\u3060\u304b\u3089\u3067\u3059\u3002 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\u6cbb\u9a13\u306f\u3001\u9577\u304d\u306b\u308f\u305f\u3063\u3066\u533b\u5b66\u306e\u9032\u6b69\u306e\u57fa\u790e\u3067\u3042\u308a\u3001\u65b0\u3057\u3044\u6cbb\u7642\u6cd5\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u660e\u3089\u304b\u306b\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u8fd1\u5e74\u3001\u6cbb\u9a13\u306e\u72b6\u6cc1\u306f\u5927\u304d\u304f\u5909\u5316\u3057\u3066\u304a\u308a\u3001\u4e16\u754c\u4e2d\u3067\u6cbb\u9a13\u3092\u884c\u3046\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u5909\u5316\u306b\u3088\u308a\u3001\u6cbb\u9a13\u7ffb\u8a33\u306e\u91cd\u8981\u6027\u304c\u6d6e\u304d\u5f6b\u308a\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u6cbb\u9a13\u6587\u66f8\u306e\u7ffb\u8a33\u306f\u3001\u6cbb\u9a13\u306e\u6210\u679c\u3068\u4fe1\u983c\u6027\u3092\u793a\u3059\u4e0a\u3067\u3001\u304d\u308f\u3081\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3059\u306e\u3067\u3059\u3002 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