Loading...
|
Please use this identifier to cite or link to this item:
https://nccur.lib.nccu.edu.tw/handle/140.119/60003
|
| Title: | 新藥臨床試驗制度在生技產業政策推動過程中變遷之探討
The study on the institutional change of new drug clinical trials in biotechnology industry promotion policies |
| Authors: | 鄭居元
Cheng, Chu Yuan |
| Contributors: | 溫肇東
Wen, Chao Tung
鄭居元
Cheng, Chu Yuan |
| Keywords: | 科技政策
制度變遷
臨床試驗
生技產業
爭議
science and technology policy
institutional change
clinical trials
biotechnology industry
controversy |
| Date: | 2009 |
| Issue Date: | 2013-09-04 11:56:19 (UTC+8) |
| Abstract: | 本研究之目的在探討台灣生技產業科技政策推動過程中所引發之爭議：臨床試驗(clinical trials)產業化，並以台灣地區自1960年代末期至2010年臨床試驗發展的制度變遷為研究標的，尤其是其中之生技產業政策推動及臨床試驗制度變遷，以說明該爭議如何發生及為何發生。
為發展台灣生物技術產業，行政院於2005年起推動生醫科技島(biomedical technology island)計畫，將原先為生物技術產業發展基礎設施的臨床試驗作為政策推動的主體，引發臨床試驗產業化的爭議。一般認為，此爭議是來自於促進產業發展與維護國民健康之間的利益衝突。
本研究經由制度變遷(institutional change)的觀點，探索台灣地區臨床試驗發展的歷程，認為上述臨床試驗產業化的爭議不只是產業推動與國民健康間的衝突，而是與台灣地區自1960年代末期至2010年生技產業政策推動與臨床試驗制度變遷有關。
台灣地區推動生物技術的科技政策始於1982年行政院修訂「科學技術發展方案(science technology development program」，明訂生物技術為八大重點科技之一，而後有1995年的行政院「加強生物技術產業推動方案(biotechnology industry promotion program」，2005年的行政院「生醫科技島計畫」等科技政策，本研究發現不同時期的科技政策賦予臨床試驗不同的意義，而不同時期臨床試驗的發展，其不同時期的行動者【產、官、學、研、醫】-- 包含政策決策者與政策參與者 -- 在臨床試驗制度變遷的過程中產生行動的差異；而在不同時期臨床試驗的發展階段，不同的官方行動者 -- 治理機構（governance agency）【衛生署、國科會、經濟部、科技顧問組等】，對於臨床試驗議題有不同程度的涉入。
台灣地區臨床試驗的發展在生技產業政策的型塑下，由原先之學術研究，階段性轉向協助產業發展。2005年行政院生醫科技島計畫，將臨床試驗作為政策推動的主體，擴大醫界參與生物技術產業發展，而醫界主要以醫療服務為主的制度邏輯（institutional logics）與科技政策形塑下產業發展的制度邏輯不一致（contradictions），因而引發臨床試驗產業化的爭議。
本研究發現對於科技政策的意涵為：在制訂與推動科技政策的過程中，唯有同時瞭解產業發展的歷史脈絡，才能避免產生非預期的結果（例如爭議）。本研究除探討生技產業政策推動過程中臨床試驗的制度變遷與變遷過程中所衍生的爭議，並將探討未來可能的研究方向。
The study is intended to explore a controversy derived from the Taiwan biotechnology industry promotion by government policies, industrialization of clinical trials. The study targets the institutional change of the clinical trials and the policies for biotechnology industry promotion in Taiwan from the late 1960’s through 2010 to explain why and how the controversy was incurred.
In order to develop the Taiwan biotechnology industry, the Executive Yuan implemented a Biomedical Technology Island program beginning 2005 to focus on clinical trials -- supposedly the infrastructure of biotechnology technology development -- but resulted in the controversy about the initiative of industrialization of clinical trials. It is reputedly because there is a conflict of interest between industry development promotion and how to maintain national healthcare.
From the perspective of institutional change, the study explores the evolution of clinical trials in Taiwan, holding that the aforementioned controversy is not only a conflict of interest between industry development promotion and how to maintain national healthcare but also a consequence of the institutional change of the clinical trials and biotechnology promotion by government policies from the late 1960’s through 2010.
The biotechnology industry promotion in Taiwan began with the Executive Yuan’s revision of its Science Technology Development program in 1982, designating the biotechnology as one of the eight strategic industries. The Executive Yuan followed through with a Biotechnology Industry Promotion program in 1995 and the Biomedical Technology Island program in 2005. The study finds that science and technology policies in different periods of time endowed clinical trials with different meanings while discrepant actions on clinical trials were taken by both policy makers and policy executors including the industry, government organizations, academia, research institutes and the medical community in different periods of time. The study also finds that different governance agencies, such as the Department of Health, Ministry of Economic Affairs, National Science Council as well as Science and Technology Advisory Group of the Executive Yuan, had different levels of involvement with the development of clinical trials in different periods of time.
Molded by the government’s biotechnology policies, clinical trials in Taiwan have evolved from the nature of academic research to assistance to industry development. The Biomedical Technology Island program beginning 2005 focuses on clinical trials and strengthens the medical community’s participation in biotechnology development, but the institutional logics of the medical community is primarily about medical service and its contradictions with the institutional logics of biotechnology industry development have resulted in the controversy about industrialization of clinical trials.
A science and technology policy implication identified by the study is that unexpected outcomes, such as the controversy dealt with herein, can only be avoided by understanding the historical context of an industry when the government develops and promotes the relevant policies for the industry. Moreover, the study will explore possible research directions in the future. |
| Reference: | 英文期刊與參考書目
Bhatt, A. 2004. “Clinical Trials in India: Pangs of Globalization”. Indian Journal of Pharmacology, 36, 4: 207-208.
Brint. S., &, J. Karabel. 1991. “Institutional Origins and Transformations: The case of American Community Colleges”. In W. Powell & P. DiMaggio (Eds.). The New Institutionalism in Organizational Analysis: 337-360. Chicago: University of Chicago Press.
Bryde, David James and Joby, Roger. 2007. “Product-based planning: the importance of project and project management deliverables in the management of clinical trials”. R&D Management. Oxford. 37, 4: 363
Davis, Gerald F. and Marquis Christopher. 2005. “Prospects for Organization Theory in the Early Twenty-First Century: Institutional Fields and Mechanisms”. Organization Science 16, 4: 332-343.
Davis, Gerald F. 2006. “Mechanisms and the Theory of Organizations". Journal of Management Inquiry 15, 2:114-118.
D’Aunno, Thomas. 2005. “Management scholars and public policy: a bridge too far?” Academy of Management Journal, 48, 6:949-951.
Denzin, N. K. 1978. The research act: A theoretical introduction to sociological methods (2nd). New York: McGraw-Hill.
DiMaggio, Paul J., and Walter W. Powell, 1983. “The iron cage revisited: Institutional isomorphism and collective rationality in organizational fields”. American Sociological Review 48:147-160
Fisher, Jill. 2006. “Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry”. Kennedy Institutes of Ethics Journal. Baltimore. 16, 3: 251-269
Fligstein, N. 1992. “Bank control, owner control or organizational dynamics: Who controls the large modern corporation?” American Journal of Sociology, 98: 280-307.
Friedland, Roger and Robert R.Alford, 1991. “Bringing society back In: Symbols, practices, and institutional contradictions”. In Walter W. Powell and Paul J. DiMaggio (Eds) The New Institutionalism in Organizational Analysis: 232-263. Chicago: University of Chicago Press.
Glickman, Seth, Mchutchison, John, Peterson, Eric and Cairns, Charles. 2009. “Ethical and Scientific Implications of the Globalization of Clinical Research”. The New England Journal of Medicine, 360, 8: 816
Janesick, V. J. 1998a. “The dance of qualitative research design: Metaphor, methodolatry, and meaning”. In N.K. Denzin & Y. S. Lincoln (Eds), Strategies of Qualitative Inquiry. Thousand Oaks, CA: Sage.
Hall, Peter A., and David Soskice. 2001a. “An introduction to varieties of capitalism”. In Peter A. Hall and David Soskice (Eds) In Varieties of Capitalism: The Institutional Foundation of Comparative Advantage: 1-68. Oxford: Oxford University Press.
Hoffman, J. Andrew. 1997. 2001. From Heresy to Dogma: An Institutional History of Corporate Environmentalism. San Francisco: New Lexington Press
Hoffman, Andrew J. 1999. “Institutional Evolution and Change: Environmentalism and the U.S. Chemical Industry”. Academy of Management Journal 42, 4: 351-371
Hsiao, Mei-Ling. 1998. “The current status of clinical trials and GCP in Taiwan”. Drug Information Journal, 32: 1203-1207.
Huckman, Robert and Zinner, Darren. 2008. “Does focus improve operational performance? Lessons from the management of clinical trials”. Strategic Management Journal. Chichester. 29, 2: 2
Karlberg, J. 2008. “The trial of sponsored clinical trials”. Clinical Trial Magnifier 1, 4:49-76
Karlberg, J. 2008. “Development of sponsored clinical trials in Asia”. Clinical Trial Magnifier 1, 5
Krasner, Stephen D. 1988. “Sovereignty: An institutional perspective”. Comparative Political Studies 21:66-94.
March, James G. 2007. “The Study of Organizations and Organizing Since 1945”. Organization Studies 28(1): 9-19. Sage.
Mello, Michelle, Clarridge, Brian and Studdert David. 2005. “Academic Medical Centers’ Standards for Clinical-Trial Agreement with Industry”. The New England Journal of Medicine. Boston. 352, 21: 2202-2210
Maxwell, Joseph A. 2005. Qualitative Research Design: An Interactive Approach. London: Sage
Meyer, John W. and B. Rowen.1997. “Institutionalized organizations: Formal structure as myth and ceremony”. American Journal of Sociology. 83: 340-63
Pierson, Paul. 2004. Politics in Time: History, Institutions, and Social Analysis. Princeton, NJ: Princeton University Press.
Pittigrew, Andrew M. 1997. “What is a processual analysis”? Scand. J. Mgmt 13, 4: 337-348.
Powell, Walter K. 1999. “The Social construction of an organizational field: the case of biotechnology”. International Journal of Biotechnology. 1, 1: 42-66.
PricewaterhouseCoopers. 2008. The changing dynamics of pharma outsourcing in Asia. New York.
Rynes, Sara L. and Debra L. Shaprio. 2005. “Academy of management journal editors’ forum. Public policy and the public interest: what if we mattered more?” Academy of Management Journal. 48, 6: 925-927.
Saillot, Jean-Louis and Paxton, Mark. 2009. “Industry Efforts on Simultaneous Global Development”. Drug Information Journal, 43, 3: 339-347.
Scott, Richard W. 1991. “Unpacking institutional arguments”. In W. Powell & P. DiMaggio (Eds.). The new institutionalism in organizational analysis: 164-182. Chicago: University of Chicago Press.
Scott, Richard W., John W. Meyer, and associates. 1994. Institutional environments and organizations: structural complexity and individualism. CA: Sage
Scott, Richard W. 1995, 2008, Institutions and organizations. Thousand Oaks: Sage
Scott, Richard W. and Søren Christensen.. 1995. “The Institutional Construction of Organizations”: International and Longitudinal Studies. Sage.
Scott, Richard W., Martin Ruef, Peter J. Mendel and Carol A. Caronna. 2000. Institutional Change and Healthcare Organizations: From Professional Dominance to Managed Care. University of Chicago Press.
Scott, Richard W. 2001, Institutions and organizations. Thousand Oaks: Sage.
Scott, Richard W. 2002. “Organizations and the natural environment: Evolving models”. In A. Hoffman and M. Ventresa (eds), Organizations, Policy, and the Natural Environment: Institutional and Strategic Perspectives: 453-464. Calif: Standford University Press.
Scott, W. Richard, 2003, Organizations: rational, natural, and open systems. Prentice Hall. (with 1981, 1987, 1992, 1998, 2003 editions)
Scott, Richard W. 2004. “Competing logics in health care: professional, state, and managerial”. The sociology of the economy, Frank Dobbin (Ed), 267-287, New York: Russell Sage Foundation
Scott, Richard W. 2005. “Institutional theory: Contributing to a theoretical research program”. In Ken G. Smith and Michael A. Hitt (Eds) In Great Minds in Management: The process of Theory Development: 460-484. Oxford: Oxford University Press.
Scott, Richard W. and Gerald F. Davis. 2007. Organizations and organizing: rational, natural, and open system perspectives. N.J: Pearson Prentice Hall
Scott, Richard W. 2008, Institutions and organizations. Thousand Oaks: Sage.
Tassignon, Jean-Pierre. 2006. « The Globalization of Clinical Trials”. Applied Clinical Trials, 15, 1: 42-44.
Theirs, Fabio A, Sinskey, Anthony J, and Berndt, Ernst R, 2008. “Trends in the Globalization of Clinical Trials”. Nature Reviews Drug Discovery, 7, 1: 13-14.
Van Arnum, Patricia. May, 2009. “Taiwan, no longer a life-sciences island unto itself”. Pharmaceutical Technology.com. Advanstar Communications.
Will, Catherine, 2009. “Identifying Effectiveness in ’The Old old’: Principles and Values in the Age of Clinical Trials”. Science, Technology & Human Values. Cambridge, 34, 5: 607
Zuker, L. 1983. “Organizations as institutions”. In S. Bacharach (Ed.), Research in the sociology of organizations: 1-47. Greenwich, CT: JAI Press.
中文期刊與參考書目
周雪光，2003，組織社會學十講，北京：社會科學文獻
吳思華，2000，策略九說：策略思考的本質，台北：臉譜
高熏芳、林盈助、王向葵(譯)，2001，質化研究設計：一種互動取向的方法Maxwell, Joseph A. 1996. Qualitative Research Design: An Interactive Approach，台北：心理
葉嘉新、林志六(編)，2008，新藥開發與臨床試驗，台北：威秀資訊科技
楊玉玲、羅時成，1999，肝炎聖戰：台灣公共衛生史上的大勝利，台北：天下文化
經濟部工業局，2009，生技產業白皮書，經濟部工業局
蕭瑞麟，2006，不用數字的研究：鍛鍊深度思考力的質性研究，台北：培生教育
秦慶瑤，2004，生技產業委外代工的動向與機會，經濟情勢暨評論，9，4: 30-51
莊慧明，2001，生物技術服務業，產業調查與技術季刊，138: 36-51
劉文婷2006，執行高品質的臨床試驗--我們準備好了嗎？，臨床試驗中英文季刊，1: 42-47
邵愛玫，2006，篇名:臺灣臨床試驗嚴重不良事件通報監測機制，臨床試驗中英文季刊，2: 53-58
彭瓊芳，2006，以生物科技產業角度探討疫苗臨床試驗，臨床試驗中英文季刊，3: 15-20
林青青，陶光恆，2006，生技製藥委託研究產業趨勢探討，臨床試驗中英文季刊，3: 9-14
張啟仁，2006，臨床資訊科技操作平臺建置之必要性，臨床試驗中英文季刊，4: 24-31
鮑力恆，2007，臨床試驗研究用藥方面常見之缺失，臨床試驗中英文季刊，4: 32-35
劉仁沛，2007，臨床試驗查核與統計方面缺失，臨床試驗中英文季刊，4: 12-25
何善台，李玉菁，王如娥，2007，臨床試驗查核現況與發展，臨床試驗中英文季刊，4: 2-11
董淑敏，2008，簡介美國之新藥研發關鍵途徑，臨床試驗中英文季刊，3，4: 2-7
王玫，李芝瑩，吳雅琪，林敏雄，2008，近三年查驗中心臨床試驗計劃書統計缺失之分析，臨床試驗中英文季刊，3，4: 41-49
廖宗志，林敏雄，2008，臨床試驗受試者同意書製作注意事項，臨床試驗中英文季刊，3，3: 2-5
陳玲貴，2008，銜接性試驗之法規介紹及現況探討，臨床試驗中英文季刊，3，2 : 2-10
陳瑩如，2008，我國新藥臨床試驗之申請流程及法規要求，臨床試驗中英文季刊，
3，1: 2-13
陳恆德，2006，國內臨床試驗現況簡要問答，財團法人醫藥品查驗中心
行政院衛生署，2006，臨床試驗政策說明，行政院衛生署
秦慶瑤，2007，藥物委外研發及生產趨勢及亞太市場競爭分析，生物技術開發中心ITIS計畫
秦慶瑤，2009，生物技術產業年鑑，生物技術開發中心ITIS計畫 |
| Description: | 博士
國立政治大學
科技管理研究所
893595022
98 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0893595022 |
| Data Type: | thesis |
| Appears in Collections: | [科技管理研究所] 學位論文
|
Files in This Item:
| File |
Size | Format | |
|---|
| 502201.pdf | 2418Kb | Adobe PDF2 | 570 | View/Open |
|
All items in 政大典藏 are protected by copyright, with all rights reserved.
|
