探討臺灣與美國對於臨床試驗Phase I階段法規差異與臺灣製藥業現階段面臨的困境

Abstract

目前臺灣國內與國際趨勢將整個新藥開發的過程分工進行，而非自行投入，製藥廠通常會請委託研究機構公司（Contract Research Organization, CRO）進行臨床試驗，原因在於可以透過公平公正的第三方來完成其中重要的樞紐試驗，避免自行試驗引發外界質疑。對製藥廠來說，如何能縮短研發的過程，讓新藥能夠越快取得藥證並且上市，是非常值得關注的議題。然而臨床試驗是新藥上市前的最重要關卡，如何縮短臨床試驗時間同時取得最多、最有效的臨床案例，非常重要。本研究以美商CRO公司為研究對象，探討臺灣現階段對於新藥第一期臨床試驗上所面臨的困境，並以美國為學習參考對象，使用質性研究中半結構式的架構，並採用立意取樣方式訪談專業人員，藉由實際過往的經驗與現在法規規範對照，將採訪中所收集的資料分析歸納成臨床試驗場所資源、健康受試者、人體試驗委員會（Institutional Review Board, IRB）送審以及權責單位三類進行討論，進而探討臺灣在法規層面上是否仍有改善空間。

Team work in the new drug development process is the international trends in most countries. Pharmaceutical companies usually delegate the conduct of clinical trials to CRO companies because the pivotal trials can be completed through a fair and equitable independent third party. For pharmaceutical companies, how to expedite new drug development process and get the drug license as soon as possible are issues of concern. The most critical step is the completion of clinical trials, how to speed up in the execution of clinical trials, recruit more subjects, and obtain quality clinical data efficiently are quite important. In the present study, we interviewed an international CRO company to explore the current challenges in conducting Phase I trials faced by Taiwan’s pharmaceutical industry. We used the semi-structured scope in qualitative research, through intentional sampling to invite experienced professionals. Through understanding current practice and comparing the regulations in Taiwan and that of the United States, the present research investigated three aspects, including clinical site resources, healthy volunteer, and IRB approval and government agency, and discussed how to improve the regulatory environment in Taiwan.