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研究生:蔡揚璽
研究生(外文):Tsai, Yang-Hsi
論文名稱:如何策略性的在台灣建立臨床中心實驗室?
論文名稱(外文):How to strategically adopt the Central Laboratory model in Taiwan?
指導教授:宋皇志宋皇志引用關係
指導教授(外文):Sung, Huang-Chih
口試委員:詹文男鄭至甫
口試委員(外文):Tsan, Wen-NanJeng, Jyh-Fu
口試日期:2022-01-20
學位類別:碩士
校院名稱:國立政治大學
系所名稱:經營管理碩士學程(EMBA)
學門:商業及管理學門
學類:企業管理學類
論文種類:學術論文
論文出版年:2022
畢業學年度:110
語文別:英文
論文頁數:57
中文關鍵詞: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
外文關鍵詞:ClinicalCentral laboratoryClinical trialsMedical laboratoryCentral clinic laboratoryStrategic alliance
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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.
摘要 I
ABSTRACT II
LIST OF FIGURES V
LIST OF TABLES VII
ACKNOWLEDGMENTS VIII
CHAPTER 1: INTRODUCTION 1
CHAPTER 2: CENTRAL LABORATORY 6
2.1 Central Laboratory become the standard for clinical trials 6
2.2 Central laboratories versus local laboratories 11
2.3 Central Laboratory is not a new concept in Taiwan 14
2.4 Discussion 15
CHAPTER 3: PORTERS’ THEORIES OF COMPETITIVE STRATEGY AND ADVANTAGES 18
3.1 Historical Development Competitive Strategy and Advantages 18
3.2 The Competitive Advantage of Nations: Porter’s Diamond Model 19
3.3 Discussion 21
CHAPTER 4: WHAT CAN WE LEARN FROM SINGAPORE? 23
4.1 Singapore vs. Taiwan 23
4.2 Porter’s Diamond Theory on the National Competitive Advantage 29
4.2.1 Government 29
4.2.1.1. Political stability 29
4.2.1.2. Legal Environment 30
4.2.1.3. Financial Environment 30
4.2.1.4. Tax Rates 31
4.2.1.5. Education 31
4.2.2. Demand 32
4.2.3. Firm Strategy, structure, and rivalry 32
4.2.4. Related and support industries 33
4.2.5. Factor Conditions 33
4.2.6. Chances 34
4.2.6.1 COVID-19 versus Decentralized Clinical Trials (DCTs) 34
4.2.6.2. Era of precision medicine 34
4.2.6.3. Chance of steer away from the dependence on semiconductor economy 35
4.2.6.4. Increase in the Central Lab operating costs 36
4.3 Conclusion 36
CHAPTER 5: STRATEGY 38
5.1 Strategic Vision 38
5.1 Business Model and Timeline 39
5.2 LIMS Design 42
5.3 Accreditation and Certification 45
5.4 Conclusion 49
REFERENCE 55
英文:
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