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KMID : 1142220140090010007
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 1 p.7 ~ p.15
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Study on the Guidance for Adaptive Design Clinical Trials to Activating Drug Development
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Choi Jong-Youl
Kim Young-Hoon
Shin Hee-Jung
Ha Ji-Hye
Kim Hae-Deun
Seo Doo-Won
Na Han-Sung
Chung Myeon-Woo
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Abstract
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As Drug development has rise important field in the national competitiveness, national has actively expanded support to development of new drug. However, Currently facing the biggest problem in the pharmaceutical industry is the continued degradation of the R & D productivity. The degradation of these R & D productivity was acting low success rate of clinical trials as bottlenecks. One of the proposed methods is "Adaptive Design Clinical Trials" in order to increase the efficiency of clinical trials. Through the interim analysis in early clinical trials design based initial lack of information, Adaptive clinical trials has the potential to increase the success rate of clinical trials. Because of expectation increased the success rate of new drug development by more efficient clinical trial, The attention of the regulators and the pharmaceutical industry is growing, Even though The concept of an adaptive clinical trial design is still in its infancy. Therfore, in this study, we propose to appropriate domestic considerations international through review of international adaptive clinical trials-related guidances. By providing the national foundation of adaptive design clinical trials, it will be able to promote the development of new drugs and gain a international level of competitiveness of domestic clinical trials.
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KEYWORD
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Drug development, Clinical Trials, Adaptive Design
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