如何提升臨床試驗中心創新及競爭力 —以北區一家醫學中心為例

Abstract

政府歷年來推動各項經濟建設，從法規制度、投資環境、專案研究計畫、國家型計畫、人才培訓、生技園區等項目著手，整合相關部會，全面推動我國生物技術產業之發展，在新藥開發臨床試驗上也是不遺餘力。2011年由國科會、經濟部、衛生署與原能會共同規劃推動「生技醫藥國家型科技計畫」（National Research Program for Biopharmaceuticals， NRPB），推動以新藥/新試劑/新治療策略/新興醫材探索研發為主之目標導向研究，落實研發成果進入臨床前試驗及初期臨床試驗。而生技/醫藥產業研發也已形成價值鏈，企業也于2012年成立「台灣研發型生技新藥發展協會」(TRPMA) 研發生技新藥。然而台灣的產、學、研、醫單位，經過多年努力創造豐富的成果，卻仍無法落實移轉產業促成生技產業發展，其中有一重要原因，就是缺乏扎實的第一期臨床試驗中心。進入了試驗中新藥（Investingational New Drug, IND）,而無完善的第一期臨床試驗來篩選測試，空有充足的第三期臨床試驗醫師，執行外商跨國臨床試驗，只在學術上、應用上和對國外產業有貢獻而已。 本論文著重於產業發展、有應用價值的臨床研究，而非僅努力提升學識研究，發表文章。藉由本論文，我們將補強臨床試驗中心的Phase I研究案, 針對試驗團隊，與藥廠、CRO加強合作，提升標準達到符合FDA， EMEA查核標準，落實並定期修正臨床試驗SOPs，增加檔案室及改善受試者休閒視聽室及改進會議室，提升 IRB、簽約效率，建立健康受試者資料庫及病人收案合作聯盟，爭取參與國際新藥Phase I、國內、外廠商來台執行臨床試驗及設立臨床R＆D中心，與CRO公司合作進行第一期臨床試驗，與國內外生技藥廠合作，執行生技醫藥國家型科技計畫（NRPB），協助國內廠商執行一定數量的醫療器材臨床試驗。

In order to push our biotechnology industry, government over the years to promote the economic development, improve investment environment, and establish ad hoc research projects. By integration of related ministries, it also spared no effort on the development of new drugs in clinical trials. In 2011, by the National Science Council, Ministry of Economic Affairs, and the Department of Health with the original plan, they joint together to promote the program called National Research Program for Biopharmaceuticals (NRPB). The goal is to explore new drugs / new reagents / new therapeutic strategies / emerging medical material into the early pre-clinical tests and clinical trials. The biotech / pharmaceutical industry R & D value chain has been formed. Companies set up a 'Taiwan biotechnology research-based Association for the Development of New Drugs' (TRPMA) biotechnology research and development of new drugs in 2012. However, Taiwan's industry, academia, research, medical units, after years of efforts to create a fruitful, still unable to implement the transfer of industry to promote the development of the biotechnology industry, which has an important reason is the lack of a solid first clinical trial center. Entered the trials of new drugs (Investingational New Drug, IND), no complete the first phase of clinical trials to test the filter, it takes plenty of Phase III clinical trial physicians, foreign multinational clinical trials performed at academic, applied only on and foreign industry contributes only. This paper has focused on the industry, and there is value in clinical research. With this thesis, we has studied the case of the reinforcing Phase I clinical trial center for testing teams, and pharmaceutical companies, CRO cooperation, and to improve standards to comply with FDA, EMEA IEC standards. Also, we periodically revised clinical trials SOPs, improved our leisure auditorium and conference rooms, and enhanced the IRB, signed efficiency and established a database of healthy subjects and patients. In Phase I clinical trials, we have cooperated domestic and foreign manufacturers to set up station to perform clinical trials and will try to establish clinical R & D centers. Also, we cooperated with CRO companies to help domestic and foreign biotech pharmaceutical companies to perform a certain number of clinical trials, and NRPB grants.