2024-05-182024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/715791In recent years, the biotechnology development has always been the first priority for the national health care industry in Taiwan. However, as the most critical step in new drug development, human clinical trials in Taiwan have faced the bottleneck for the past few years because of the complexity and high costs. In order to encourage the development of biotechnology industry and make up for the gap of downstream supply chian in new drug development process, National Taiwan University Hospital (NTUH) established the ""National Center of Excellence for Clinical Trial and Research"" in 2005 in response to the ""Biotech Takeoff Diamond Action Plan"" from the Executive Yuan, Republic of China (Taiwan) and played the leading role of biotechnology industry R&D and clinical implementation in Taiwan. After focusing on innovative research and development strategies in clinical trials for these years, we have built a great clinical research environment and operating system, achieving distinctive results in doing new drug clinical trial research. In 2011, we won the 1st National Industrial Innovation Award in Taiwan. Besides, many international biotechnological pharmaceutical companies and clinical trial companies cooperated with NTUH to establish R&D centers in Taiwan because of the recognition for our innovative strategies and distinctive results. Combining global leading positions of international pharmaceutical companies in treatment areas of different diseases, our collaborations speed up new drug clinical research, benefiting patients around the world. We conduct about 600 new drug clinical trials each year, including more than 40 new drug Phase I trials, including more than 40 international clinical trials. We hold positions of principal investigators and members of steering committee for international clinical trials. Now NTUH plays a leading role of clinical trials and research in the Asia Pacific Region and makes great contribution in the development and innovation of the biotechnology industry in Taiwan.近年來政府積極推動生物科技產業發展，但人體臨床試驗研究為新藥開發最關鍵但也最複雜與昂貴的研發階段，多年被認為是台灣生技研發瓶頸及不可能解決之問題。為彌補台灣新藥研發之下游產業臨床試驗研發供應鏈缺口，並帶動台灣整體新藥產業發展，本院配合行政院「臺灣生技起飛鑽石行動方案」，自2005年設置「國家級卓越臨床試驗與研究中心」，協助臺灣生技產業落實生技產品在臨床階段的應用與研發。 因長期致力於臨床試驗創新之研發策略與經營模式，建置優質的臨床試驗研究環境與作業系統，推動新藥人體臨床試驗研究表現傑出，2011年本中心榮獲第一屆國家產業創新獎。同時因創新策略和優越成果受到多家國際生技醫藥大廠以及臨床試驗公司的肯定，陸續來臺設立研發中心，結合國際藥廠在不同疾病治療領域上的全球領導地位，彼此合作以加速新藥的臨床研發，嘉惠全球病患。本院目前每年執行約 700 件新藥臨床試驗，包括執行 100 多件新藥第一期(Phase I)臨床試驗研究，並主導40多個國際臨床試驗，擔任國際臨床試驗計畫總主持人、Steering Committee Member等，本中心目前已成為亞太區卓越臨床研發中心，對協助臺灣整體生技產業發展具有影響性及創新性之貢獻