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    題名: 臨床試驗受試者保護：從利害關係人觀點探討CRA監測功能之提升
    Clinical Trial Subject Protection:The enhancement of CRA monitoring from stakeholder perspectives
    作者: 李雅玟
    Lee, Ya Wen
    貢獻者: 温肇東
    Wen, Chao-Tung
    李雅玟
    Lee, Ya Wen
    關鍵詞: 試驗監測員CRA
    受試者
    臨床試驗
    監測
    利害關係人
    社會重大事件
    CRA
    clinical trial subject
    clinical trial
    monitoring
    stakeholder
    social serious events
    日期: 2012
    上傳時間: 2013-09-02 16:10:13 (UTC+8)
    摘要: 隨著新藥研發臨床試驗受試者安全與權利有關的社會重大事件日漸增加，我們迫切需要了解造成這些事件的根本原因。本研究發現，關鍵根本原因之一與可能的答案，存在於可以早期辨識新藥危害受試者安全與權利是否被依法規受保護的臨床試驗監測業務。

    至今，似乎未有人針對試驗監測員(CRA)工作、時間與能量分配，這些與臨床試驗監測業務品質有關的因素做研究。由利害關係人分析、交易成本理論與白地策略角度，本研究針對兩面向，進行分析: 1) 全球化分工對台灣臨床試驗的衝擊 2) 台灣臨床研究專員面臨監測業務的四大阻礙，因而失去了早期辨識新藥危害受試者安全與權利的機會，並提出處理下列四大阻礙的相關建議:
    1)舒緩目前由全球化分工過度造成的CRA大增的工作量、事務範圍縮小、警覺變差等影響;
    2)降低由CRO組織複雜與效能不佳造成的內部交易成本;
    3)降低由主持人團隊責任不明、或無充裕時間執行試驗，試驗地點額外事務造成的額外交易成本;
    4)降低由委託者當地代表不當期盼與干涉造成的外部交易成本
    With the increasing of serious social incidents related to the safety and welfare of the clinical trial subjects, their causes are urgently needed. This study finds that the main causes as well as their solutions may reside in whether or not the monitoring process, which is more frequent than audits and inspections, can provide an early detection of side effects during a clinical trial so that the safety and welfare of the clinical trial subjects can be protected according to the related laws and regulations.

    To date, there are not many studies have focused on the distribution of work, time, and effort, factors that are closely related to the quality of the monitoring of the clinical trials, of the Clinical Research Associates (CRAs, a role defined by the GCP and related regulations). From the viewpoints of the stakeholders, the theory on the transaction costs, and the “seizing the white space”, this study made a descriptive analysis on the following two aspects: 1) the impact on Taiwan clinical trial due to over division of work from globalization and 2) CRAs in Taiwan are confronted with four hindrances, when monitoring a clinical trial, which results in missed opportunities in early discovery of clinical trial victims and, subsequently, endangering their lives, safety and welfare. The following suggestions are proposed to minimize the impact from the four hindrances:
    a) To alleviate CRAs’ increased workload, narrowed scope, and reduced sensitivity suffered from over division of work in globalization.
    b) To reduce the internal transaction cost resulted from the poorly organized CRO.
    c) To reduce the external transaction cost brought by the ambiguousness in the responsibility of the investigator, inadequate experimental time, or the overflow of the extra affairs at the experimental sites.
    d) To reduce the external transaction cost resulted from the improper expectations and interferences by the local representatives of the sponsors.
    參考文獻: 參考文獻
    一、英文部分：

    •"New Research offers CRO market snapshot", Kirsty Barnes, Outsourcing-Pharma, November 22, 2007

    •"Top 10 Areas of Research", Michael D. Christel, R&D Directions, vol. 14, no. 9, October 2008, pg. 20

    •"Riding the Wave", Pharmaceutical Executive Europe, FOCUS Oncology, September 2007, pp. 3–5.

    •"The CRO Market", Association of Clinical Research Organization, 2012

    •"Quintiles in $3bn investment deal". Outsourcing-pharma.com. Jan2, 2008.

    •"CRO market to reach $24bn by 2010". Outsourcing-pharma.com. Jul30, 2007.

    •"Report linker Adds The CRO Market Outlook: Emerging Markets, Leading Players and Future Trends. | Trends & Events > Trends from". AllBusiness.com. Sep21, 2009.

    •"US Clinical Drug Trial Contract Research Organization: Component Database". Medibix.com. May17, 2010.

    •PPD, Kendle and ICON top CenterWatch’s 2011 global CRO report card BOSTON, Mass., May 2, 2011 http://www.centerwatch.com/press/pr-2011-05-02.aspx

    •CRO Market View What lies ahead of the curve? By Brad Anderson
    http://www.contractpharma.com/issues/2008-03/view_features/cro-market-view/

    •The CRO Market Outlook: Emerging Markets, Leading Players And Future Trends. Viewed April 02, 2008.
    http://www.marketresearch.com/product/display.asp?productid=152687 2&g=1

    •China Contract Research Organization (CRO) Industry Report, 2010-2011
    http://www.reportlinker.com/p0590608/China-Contract-Research-Organization-CRO-Industry-Report-2010-2011.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Disc

    •Globalization White Paper, 25May, 2012 http://www.acrohealth.org/globalization-white-paper.html

    •A Glance at the Clinical Research Organization Industry By Janine Richardson 28Oct2009,(website: 14Nov2011) http://ezinearticles.com/?A-Glance-at-the-Clinical-Research-Organization-Industry&id=3135697

    •Insight: Pharma asks the money question earlier for new drugs, 20Dec, 2011.http://www.linkedin.com/news?actionBar=&articleID=996929498&ids=0VdjkScz0QejAIejgOdj0TdjoVb3wVd3AOejoVeiMVdPoRdjkRe3AId3gSdPwScPAV&aag=true&freq=weekly&trk=eml-tod2-b-ttl-2&ut=3XMK4H53fkV501

    •Documentation of the Informed Consent Process, 24Nov, 2009.
    http://www.mcw.edu/hrpp/QualityImprovementProgram/checklists/DocumentationoftheInformedConsentProcess.htm

    •FDA “ALCOA” Guidance, 1999. http://www.fda.gov/ohrms/dockets/dailys/04/June04/061504/04N-0133_emc-000034-01.ppt

    •Awakenings (1973, rev. ed. 1990) Oliver Sacks Paperback, Vintage Books, ISBN 0-375-70405-1

    •Stockholders and Stakeholders: A new perspective on Corporate Governance. by Freeman, R. Edward; Reed, David L.. California Management Review, Spring83, Vol. 25 Issue 3, p88-106

    •Freeman, R. Edward (1984). Strategic Management: A stakeholder approach. Boston: Pitman. ISBN 0-273-01913-9

    •Redefining the Corporation Stakeholder Management and Organizational Wealth(2002) by James E. Post, Lee E. Preston, and Sybille Sachs

    •“Implications of Physician Payment Act”, William Sharbaugh, 1Oct2010, Applied Clinical Trials.

    •Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, 24Aug2011.

    •“Flying Blind on CRA Workload, Time Demands”, Kenneth A. Getz, July 2012, Applied Clinical Trials.


    二、 中文部分：

    •鄭居元 ，《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》，國立政治大學科技管理研究所博士論文，2009年。
    •洪錫娟，《台灣發展醫藥研發服務產業之探討-以臨床試驗部分為例》，國立政治大學科技管理研究所碩士論文，2005年。
    •鍾曉芬，《台灣臨床試驗服務公司 (CRO) 營運模式之探討- 以藥品研發為例》，國立政治大學經營管理碩士學程(EMBA)碩士論文，2010年。
    •馬克強生著，《白地策略》，天下遠見出版，2010年11月初版。
    •蕭瑞麟著，《不用數字的研究》，台灣培生教育出版股份有限公司，2011版。
    •藥品優良臨床試驗準則, 2005。
    •艾瑞克•弗洛姆著，《逃避自由》1941。
    •李育融，《影響參與臨床試驗之動機研究：以健康受試者為例》，國立中山大學醫務管理研究所碩士論文，2011年。
    •彭嚴燕，《全球藥品委外代工(CRO)的現況與未來》，2009年。
    •王蓉君、陳恆德，《台灣臨床試驗發展之沿革》，2011年。
    •吳惠林，《飛越黑板經濟學》翰蘆圖書出版有限公司出版，2000年。
    •製藥業廠商委外問卷調查報告，2012年。
    •96年國際廠商收購或高額投資的台灣生技公司，商業周刊1064期，2008年。
    •立法院公報第98卷第43期委員會紀錄，2009年。
    •陳肇文醫師演講資料，《台灣法律變遷下之人體試驗》101人體試驗講習班講義，2012年。
    •曾育裕副教授演講資料，《台灣法律變遷下之人體試驗》101人體試驗講習班講義，2012年。
    •劉維公，《文化產業的時代意義》，典藏今藝術，2003年。
    •佛里曼著，《我們曾經輝煌》，2012年。
    •吳清在教授演講，《台灣地區大學教授薪資待遇之合理性初探：大、中、小學教師之比較研究》
    •台大醫院受試者知情同意過程紀錄格式(含說明) ，2009年。
    •「建立臨床試驗與研究體系計畫」的推動與執行出國報告，2007年。

    三、 網頁部分：

    •台灣生技新藥產業發展策略, 2008葉明峯簡報資料 <www.centerforpbbefr.rutgers.edu/TaipeiPBFR&D/0530-31%20papers/3-1.ppt >

    •Merck的Vioxx 止痛藥事件 <http://www.reuters.com/article/2012/04/19/us-merck-vioxx-idUSBRE83I1EE20120419 >

    •臨床研究專業服務機構（CRO）以徵求工讀生的名義違反規定招募健康受試者事件<http://n.yam.com/newtalk/life/201010/20101007238745.html>

    •醫改會對「台大 / 成大醫院誤植愛滋器官事件」聲明稿<http://www.thrf.org.tw/Page_Show.asp?Page_ID=1435>

    •藥物測試致下顎壞死 家屬控長庚與諾華不認帳
    2011/05/19 自由時報 記者曾韋禎、李容萍、王昶閔／綜合報導
    <http://www.thamd.org.tw/medispute.php#informed11>

    •「血汗醫院」 全台竟有16家員工超時工作 還沒加班費 署基也上榜 2011年 06月20日
    <http://tw.nextmedia.com/applenews/article/art_id/33471757/Issue ID/20110620/pvtype/r>

    •Association of clinical research organization 臨床研究機構協會<http://www.acrohealth.org>

    •ClinicalTrials.gov < www.clinicaltrials.gov>

    •長庚醫療財團法人長庚紀念醫院卓越臨床試驗中心<http://www1.cgmh.org.tw/intr/intr2/c3s400/html/mission.html>

    •台灣黄頁<http://www.web66.com.tw/ch/61/CW102/Blog/102171.html>

    •臨床試驗審查作業機制說明-石麗鳳科長(2012/5/28網頁) <http://www.cde.org.tw/action/uploadfile/2011/1000927and0929/4.%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a9%97%e5%af%a9%e6%9f%a5%e4%bd%9c%e6%a5%ad%e6%a9%9f%e5%88%b6%e8%aa%aa%e6%98%8e-%e7%9f%b3%e9%ba%97%e9%b3%b3%e7%a7%91%e9%95%b7.pdf>

    •專案合約與屨約管理<http://www.iiiedu.org.tw/ites/PContract.htm>

    •”藥物人體試驗導致下顎骨壞死及切除”中央社記者陳偉婷台北18日電(2011May) <http://n.yam.com/cna/politics/201105/20110518049972.html> (29May2012)

    •2006台灣各產業景氣趨勢調查報告 西藥製藥產業<www.biotaiwan.org.tw/download/structure4/陳嘉宏/2005> (29May2012)

    •英國Phase I TGN1412 事件<http://en.wikipedia.org/wiki/Talk:TGN1412/Archive1>;
    <http://www.fiercebiotech.com/story/unexpected-death-brings-medigene-phase-i-halt/2008-07-08、http://www.i-sis.org.uk/LDTC.php>

    •典型美國的監測員一週工作<http://www.indeed.com/forum/job/Clinical-Research-Associate/job-opportunities-CRA/t32649>
    描述: 碩士
    國立政治大學
    經營管理碩士學程(EMBA)
    99932133
    101
    資料來源: http://thesis.lib.nccu.edu.tw/record/#G0099932133
    資料類型: thesis
    顯示於類別:[經營管理碩士學程EMBA] 學位論文

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