政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/139186

政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/139186

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政大機構典藏 > 商學院 > 經營管理碩士學程EMBA > 學位論文 > Item 140.119/139186

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題名:	如何策略性的在台灣建立臨床中心實驗室? How to strategically adopt the Central Laboratory model in Taiwan?
作者:	蔡揚璽 Tsai, Yang-Hsi
貢獻者:	宋皇志 Sung, Huang-Chih 蔡揚璽 Tsai, Yang-Hsi
關鍵詞:	臨床臨床中心實驗室臨床試驗醫學實驗室臨床中央實驗室策略聯盟 Clinical Central laboratory Clinical trials Medical laboratory Central clinic laboratory Strategic alliance
日期:	2022
上傳時間:	2022-03-01 17:02:45 (UTC+8)
摘要:	臨床試驗對於評估針對疾病狀況的療法和醫療設備至關重要，它們也是最昂貴的藥物開發過程之一。在臨床實驗中，中心實驗室扮演著舉足輕重的角色，包含從臨床樣本分析與提供高質量數據與報告、各種生物標記物開發驗證、項目管理、臨床數據庫建立以及臨床樣本儲存。台灣於 1993 年引入臨床試驗系統，比中國（China Clinical Trial Registry, 2005）和韓國（KONECT, 2007）早得多，但我們沒有充分的利用我們的競爭優勢，例如先進的醫療基礎設施、訓練有素的醫療專業人員、發達的軟體設計業、亞太區中心戰略地理位置、廣泛且方便的物流服務網絡以及其他優勢來建立一個臨床生態圈。目前台灣並沒有任何國際企業設立任何的臨床中心實驗室，反而在東南亞新加坡設立它們的區域性實驗室以及亞太區總部，從這點可顯現出台灣在臨床研究競爭力不足。目前台灣在世界的競爭力依舊源於電子製造業以及代工，其中以定國神山台積電以及鴻海為行業中的翹楚。本文認為，台灣的經濟應該減少對半導體以及電子製造業的依賴。台灣在臨床試驗基本上還是遵循的代工模式，提供勞力與時間換取的微薄的利潤。而國外臨床研究機構通過安排設計臨床試驗以低價購買了我們的專業以及知識經濟，臨床中心實驗室透過分析臨床樣本從藥廠賺取了豐厚的回報。台灣醫院過去在醫療健保制度下經營運作日趨困難，為了求生存透過策略聯盟更有效的運用醫療資源，更投資副業改善財政缺口，政府透過剝削醫護，把專業的技術與知識當成低價商品。實則臨床試驗可以賦予這些臨床知識與技術更高的經濟價值，然台灣目前還沒有完整的政策與生態系統來整合醫療資源，以利用知識經濟來提供國外業者更高價值的服務，進而讓產業收益最大化。本論文透過波特鑽石模型分析台灣的國家競爭優勢，再以新加坡的成功為參考分析優劣勢。本論文認為台灣適合利用既有的醫療資源來設立區域性臨床中心實驗室，來達到最大效益以及對經濟產生貢獻。本論文最後進行策略分析，提出設立實驗室的商業模型以及實驗室流程建議。 Clinical trials are essential in the evaluation of therapies and medical devices for diseases conditions. They are also one of the most expensive steps in the drug development process. Taiwan introduced the clinical trial system in 1993, much earlier than China (China Clinical Trial Registry, 2005) and South Korea (KONECT, 2007). However, we did not take full advantage of our advanced medical infrastructure, highly qualified medical professionals, strategic geographical location, affordable software design industry, extensive logistic service network, and government policies to enhance the competitiveness of medical industries and establish a clinical trial ecosystem. Taiwan is practically a blue ocean for the clinical research continuum as there are no international clinical central laboratories. Most transnational clinical service providers are located in Singapore. The Taiwanese economy is still heavily reliant on the electronics manufacturing industry and foundry; among them, TSMC and Foxconn are the leaders in the industry. Hospitals in Taiwan receive a small token of appreciation for their services in clinical trials. This is not different from our manufacturing industry’s “outsourcing model” where labor and time are spent in exchange for meager payment. Foreign clinical research institutions are exploiting medical expertise and services at a low cost to generate a high return. Foreign clinical central laboratories have also earned lucrative revenues from analyzing clinical samples. On the contrary, hospitals’ revenue has been negatively impacted National Health Insurance Act (NHIA) by treating the medical profession as cheap commodities. Hospital business operations are becoming increasingly difficult and strategic alliances are formed between clinical laboratories, and hospitals are investing in side hustles to keep the business afloat. We have identified Taiwan`s competitive advantages and weaknesses referencing Singapore’s success using Porter’s Diamond Model. Despite the need for continuous improvement and resource integration, Taiwan has great potential to become the next regional clinical hub, thereby offering higher-value clinical services and contributing to the local economy.
參考文獻:	英文: 1. Bartholomew, M. (2002). James Lind`s Treatise of the Scurvy (1753). Postgrad Med J, 78(925), 695-696. doi:10.1136/pmj.78.925.695 2. Bhatt A. (2010). Evolution of clinical research: a history before and beyond james lind. Perspectives in clinical research, 1(1), 6–10. 3. CDER/FDA (2020) 2015-2019 Drug Trials Snapshots Summary Report: Five-Year Summary and Analysis of Clinical Trial Participation and Demographics, US CDER/FDA 4. Christopher R. Daniels, Ph.D., Venkat R. Rajagopal, M.S., and Traci Turner, M.D. ,Central Laboratory Interlaboratory Comparison Program To Assess The Comparability Of Data Of Tests From Four Regional Laboratories Involved In Global Clinical Trials, accessed on 1 Nov 2021, (https://www.clinicalleader.com/doc/central-laboratory-interlaboratory-comparison-program-to-assess-the-comparability-of-data-of-tests-from-four-regional-laboratories-involved-in-global-clinical-trials-0001) 5. Chelsea Roth,Praxis "The real cost of clinical trials," Blog, July 25, 2017, accessed on 1, Nov 2021 https://www.gopraxis.com/real-cost-clinical-trials/ 6. Porter, M. E. (1980). Competitive strategy: Techniques for analyzing industries and competitors. New York: Free Press. 7. Porter, M. E. "How Competitive Forces Shape Strategy." Harvard Business Review 57, no. 2 (March–April 1979): 137–145. 8. Porter, M. E. (1985). Competitive advantage: Creating and sustaining superior performance. New York: Free Press. 9. Porter, M. E. (1986). Competition in global industries. Boston, Mass: Harvard Business School Press. 10. Porter, M. E. (1990). The competitive advantage of nations. New York: The Free Press. 11. World Investment Report, retrieved 7 Nov 2021, from https://unctad.org/topic/investment/world-investment-report 12. ASIA: PREFERRED DESTINATION FOR CLINICAL TRIALS, retrieved 7 Nov 2021, from https://novotech-cro.com/sites/default/files/170217_FrostSullivan_Asia%20white%20paper_full.pdf 13. The Evolution of Taiwan’s Trade Linkages With the U.S. and Global Economies, retrieved 7 Nov 2021, from https://itif.org/publications/2021/10/25/evolution-taiwan-trade-linkages-us-and-global-economies 14. The Local Central Lab Model. Applied Clinical Trials, Applied Clinical Trials (2008, Jan 4th), Volume 0, Issue 0 https://www.appliedclinicaltrialsonline.com/view/local-central-lab-model-0 15. Stimulating Early Demand. (2022) Porter`s Diamond Model EXPLAINED with EXAMPLES \| B2U. Retrieved January 26, 2022, from https://www.business-to-you.com/porter-diamond-model/ 16. Taiwan GDP \| 2022 Data \| 2023 Forecast \| 1980-2021 Historical \| Chart \| News. Retrieved 26, Jan, 2022, from https://tradingeconomics.com/taiwan/gdp 17. Taiwan GDP Growth Rate \| 2022 Data \| 2023 Forecast \| 1981-2021 Historical \| Calendar. Retrieved 26, Jan, 2022, from https://tradingeconomics.com/taiwan/gdp-growth 18. Taiwan Average Monthly Wage In Industry and Services \| 2022 Data \| 2023 Forecast. Retrieved 26, Jan, 2022, from https://tradingeconomics.com/taiwan/wages 19. The College Of American Pathologists. (2022) Accredited Laboratory and Biorepository Directory \| College of American Pathologists. Retrieved 26, Jan, 2022, from https://www.cap.org/laboratory-improvement/accreditation/accredited-laboratory-and-biorepository-directory/ 20. Health Topic. (2022) . Retrieved 26, Jan, 2022, from https://trialsearch.who.int/ListBy.aspx?TypeListing=2 中文: 21. 行政院科技顧問組,「台灣生技起飛鑽石行動方案」行動計畫 - 國家發展委員會, 上網日期2021年11月2日, 檢自: https://ws.ndc.gov.tw/Download.ashx?u=LzAwMS9hZG1pbmlzdHJhdG9yLzEwL3JlbGZpbGUvNjA5NS8xMTcxMS8wMDEyNDQ1LnBkZg%3D%3D&n=5Y%2Bw54Gj55Sf5oqA6ZG955%2Bz6LW36aOb6KGM5YuV5pa55qGILnBkZg%3D%3D&icon=..pdf 22. 丁詩同, 臺灣生物科技產業發展, 上網日期2021年11月2日, 檢自: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjaifbXoZz1AhXpSWwGHWo0ALMQFnoECAkQAQ&url=https%3A%2F%2Fwww.ey.gov.tw%2FFile%2F899924B0D6DE5B67%3FA%3DC&usg=AOvVaw0TsuZFxyp7GquFMSs3odZC 23. 衛生福利統計處(2021, Nov). 108年國民醫療保健支出統計表. 衛生福利部. https://dep.mohw.gov.tw/DOS/cp-5071-57717-113.html 24. 衛生福利部中央健康保險署. Retrieved 26, Jan, 2022, from https://www.nhi.gov.tw/query/query2.aspx
描述:	碩士國立政治大學經營管理碩士學程(EMBA) 109932153
資料來源:	http://thesis.lib.nccu.edu.tw/record/#G0109932153
資料類型:	thesis
DOI:	10.6814/NCCU202200154
顯示於類別:	[經營管理碩士學程EMBA] 學位論文

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