Glinical Trials in Japan and Korea-The Present State and Issues to be Solved-

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  • 日本と韓国における臨床研究の現状と問題点
  • ワークショップ 5 ニホン ト カンコク ニ オケル リンショウ ケンキュウ ノ ゲンジョウ ト モンダイテン

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Abstract

The purpose of this workshop was to discuss on various issues for the development of a protocol for the Ja pan-Korea research collaboration. An important issue is to select/develop the experimental design of the clinical trial for individualized therapy done in Japan and Korea. Randomizedn-of-1 trial and randomization test were proposed as an possible candidate. A pilot study using randomized n-of-1 trial was done using intradermal acupuncture on pollinosis, and the methodological issues on the generalizability of randomized n-of-1 trial and the need of the selection of target disease were discussed. Onthe other hand, the literature survey has shown that the individualized acupuncture therapy is more effective than those of the standardized' fixed acupuncture therapy in usual RCTs. The diagnosis and selection of acupuncture point and method of manipulation were also shown to be an important factor. Further discussions will be required for the development of the adequate protocol for the individualized therapy.

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