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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 1-Mar-2022 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.78.925.6952. 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/FDA4. 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-report12. ASIA: PREFERRED DESTINATION FOR CLINICAL TRIALS, retrieved 7 Nov 2021, fromhttps://novotech-cro.com/sites/default/files/170217_FrostSullivan_Asia%20white%20paper_full.pdf13. 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-economies14. 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-015. 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/gdp17. Taiwan GDP Growth Rate | 2022 Data | 2023 Forecast | 1981-2021 Historical | Calendar. Retrieved 26, Jan, 2022, from https://tradingeconomics.com/taiwan/gdp-growth18. Taiwan Average Monthly Wage In Industry and Services | 2022 Data | 2023 Forecast. Retrieved 26, Jan, 2022, from https://tradingeconomics.com/taiwan/wages19. 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=..pdf22. 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=AOvVaw0TsuZFxyp7GquFMSs3odZC23. 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.html24. 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 dc.contributor.advisor 宋皇志 zh_TW dc.contributor.advisor Sung, Huang-Chih en_US dc.contributor.author (Authors) 蔡揚璽 zh_TW dc.contributor.author (Authors) Tsai, Yang-Hsi en_US dc.creator (作者) 蔡揚璽 zh_TW dc.creator (作者) Tsai, Yang-Hsi en_US dc.date (日期) 2022 en_US dc.date.accessioned 1-Mar-2022 17:02:45 (UTC+8) - dc.date.available 1-Mar-2022 17:02:45 (UTC+8) - dc.date.issued (上傳時間) 1-Mar-2022 17:02:45 (UTC+8) - dc.identifier (Other Identifiers) G0109932153 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/139186 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 經營管理碩士學程(EMBA) zh_TW dc.description (描述) 109932153 zh_TW dc.description.abstract (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。 zh_TW dc.description.abstract (摘要) 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. en_US dc.description.tableofcontents 摘要 IABSTRACT IILIST OF FIGURES VLIST OF TABLES VIIACKNOWLEDGMENTS VIIICHAPTER 1: INTRODUCTION 1CHAPTER 2: CENTRAL LABORATORY 62.1 Central Laboratory become the standard for clinical trials 62.2 Central laboratories versus local laboratories 112.3 Central Laboratory is not a new concept in Taiwan 142.4 Discussion 15CHAPTER 3: PORTERS’ THEORIES OF COMPETITIVE STRATEGY AND ADVANTAGES 183.1 Historical Development Competitive Strategy and Advantages 183.2 The Competitive Advantage of Nations: Porter’s Diamond Model 193.3 Discussion 21CHAPTER 4: WHAT CAN WE LEARN FROM SINGAPORE? 234.1 Singapore vs. Taiwan 234.2 Porter’s Diamond Theory on the National Competitive Advantage 294.2.1 Government 294.2.1.1. Political stability 294.2.1.2. Legal Environment 304.2.1.3. Financial Environment 304.2.1.4. Tax Rates 314.2.1.5. Education 314.2.2. Demand 324.2.3. Firm Strategy, structure, and rivalry 324.2.4. Related and support industries 334.2.5. Factor Conditions 334.2.6. Chances 344.2.6.1 COVID-19 versus Decentralized Clinical Trials (DCTs) 344.2.6.2. Era of precision medicine 344.2.6.3. Chance of steer away from the dependence on semiconductor economy 354.2.6.4. Increase in the Central Lab operating costs 364.3 Conclusion 36CHAPTER 5: STRATEGY 385.1 Strategic Vision 385.1 Business Model and Timeline 395.2 LIMS Design 425.3 Accreditation and Certification 455.4 Conclusion 49REFERENCE 55 zh_TW dc.format.extent 3020160 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0109932153 en_US dc.subject (關鍵詞) 臨床 zh_TW dc.subject (關鍵詞) 臨床中心實驗室 zh_TW dc.subject (關鍵詞) 臨床試驗 zh_TW dc.subject (關鍵詞) 醫學實驗室 zh_TW dc.subject (關鍵詞) 臨床中央實驗室 zh_TW dc.subject (關鍵詞) 策略聯盟 zh_TW dc.subject (關鍵詞) Clinical en_US dc.subject (關鍵詞) Central laboratory en_US dc.subject (關鍵詞) Clinical trials en_US dc.subject (關鍵詞) Medical laboratory en_US dc.subject (關鍵詞) Central clinic laboratory en_US dc.subject (關鍵詞) Strategic alliance en_US dc.title (題名) 如何策略性的在台灣建立臨床中心實驗室? zh_TW dc.title (題名) How to strategically adopt the Central Laboratory model in Taiwan? en_US dc.type (資料類型) thesis en_US dc.relation.reference (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.78.925.6952. 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/FDA4. 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-report12. ASIA: PREFERRED DESTINATION FOR CLINICAL TRIALS, retrieved 7 Nov 2021, fromhttps://novotech-cro.com/sites/default/files/170217_FrostSullivan_Asia%20white%20paper_full.pdf13. 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-economies14. 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-015. 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/gdp17. Taiwan GDP Growth Rate | 2022 Data | 2023 Forecast | 1981-2021 Historical | Calendar. Retrieved 26, Jan, 2022, from https://tradingeconomics.com/taiwan/gdp-growth18. Taiwan Average Monthly Wage In Industry and Services | 2022 Data | 2023 Forecast. Retrieved 26, Jan, 2022, from https://tradingeconomics.com/taiwan/wages19. 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=..pdf22. 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=AOvVaw0TsuZFxyp7GquFMSs3odZC23. 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.html24. 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 zh_TW dc.identifier.doi (DOI) 10.6814/NCCU202200154 en_US
