札幌医科大学医学部

分子医学研究部門

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**「バイオ研究者・大学院生のための便利メモ」**

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バイオ研究者・大学院生のための簡単な英語文例集

その18 アメリカ遺伝子治療学会の見解 つづき

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One area which requires clarification is the role of the Board in "developing information that will enhance the development, design, and conduct of human gene transfer clinical trials". Information developed by the Board will be an important resource for investigators in designing clinical trials. Nevertheless, the Society is very concerned if the proposed changes suggest that the Board will take an active role in the design of clinical trials. Design of investigational trials has been a collaborative effort between investigators and the FDA. Trial design is complex and the addition of an another, potentially conflicted, organization is not in line with the ACD Working Group recommendations for harmonization.


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