新藥一期臨床試驗概況與人體研究審查會審查實務──以北部某醫學中心為例【本期企劃】 試閱
Phase I Drug Trials in Taiwan and Their Review by Institutional Review Board (IRB)
新藥一期臨床試驗是新藥開發的重要階段，在過去我國鮮少執行此類試驗。但近年來，若干醫學中心已建立這方面的經驗與能力，並執行越來越多的國內外藥廠委託的試驗案。本文為國內首篇文章探討醫院執行新藥一期臨床試驗的概況，以及人體研究審查會的審查經驗。另參考主管機關及製藥界有關新藥一期臨床試驗的指引，整理出審查重點，包括臨床前的實驗數據是否支持進入人體試驗階段、高風險試驗的特徵、試驗風險極小化及安全監測等。最後，也針對新藥一期臨床試驗，製作審查檢核表，提供國內審查會參考使用。
A phase 1 drug trial is a milestone in the development of medicinal products. In recent decade, global and domestic drug developers have conducted more and more phase 1 trials in Taiwan. This article is the first to review the current status of phase 1 drug trials in a major hospital in Taiwan and how an institutional review board (IRB) reviewed such trials. The article also proposes a reviewer checklist to help IRB reviewers to evaluate phase 1 drug trials. The checklist is based on the guidance and guidelines issued by regulators and biopharma regarding phase 1 or first in human drug trials.
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