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研究生:黃譯鋒
研究生(外文):Yi-feng Huang
論文名稱:企業資助研究與臨床試驗:以減重藥物羅氏鮮為例
論文名稱(外文):Industry-sponsored Research and Clinical trials: the case of Orlistat
指導教授:許甘霖許甘霖引用關係
指導教授(外文):Kan-lin Shu
學位類別:碩士
校院名稱:國立成功大學
系所名稱:公共衛生研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2009
畢業學年度:97
語文別:中文
論文頁數:81
中文關鍵詞:臨床試驗企業資助利益衝突羅氏鮮
外文關鍵詞:Orlistatclinical trialindustry-sponsoredconflict of interest
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研究目的:企業資助研究是一件越來越普遍存在的現象,尤其是在藥廠與藥物臨床試驗研究間關係更為密切。藥廠需要研究以確保其專利權與收益,而研究者需要確保研究進行所需的經費來源。但是這樣的供需中卻產生問題,研究者是否會因為企業資助的利益影響其研究過程與結果。因此本研究主要研究目的有二個:一、藥廠與企業的學術資助,是否會影響學術生產流程中的研究設計、刊登發表與研究結論,而存在特定的研究過程傾向,產生系統性的偏誤?二、承上,這些研究設計或刊登發表的特定傾向是否會影響研究結論?

方法:本研究使用醫學電子期刊資料庫,收集2000年1月1日至2007年12月31日的期間所刊登的減重藥物羅氏鮮之臨床試驗研究,作為研究分析對象,並進行變項收集與編碼。對於研究流程中的研究目的、研究設計、研究結論、研究發表中的重要變項與企業資助進行相關性分析,以了解企業資助對於學術研究的影響。

結果:研究發現接受企業資助與研究目的(P=0.898)、研究結論(P=0.187)無顯著相關。在研究設計上接受企業資助的研究,傾向使用盲目(P=0.000)設計、安慰劑控制(P=0.000)、且有高受試者完成比率(P=0.049)並呈現顯著相關,在隨機方法使用上呈現相關(P=0.055)但沒有達到顯著。顯示有接受企業資助的研究,越遵循使用標準臨床試驗設計。在研究刊登中有接受企業資助的研究,傾向於刊登在有利益衝突揭露政策的期刊(P=0.003)、與刊登在較早的年代(P=0.001)且呈現顯著相關。另外在研究設計與研究結論上,只有特殊研究設計有無(P=0.083)、納入受試者的健康狀態(P=0.063)呈現相關。

結論:本研究之結果發現企業資助與否跟研究結論呈現的推薦與否無顯著相關。接受企業資助的研究相較於未接受資助者,在研究設計的過程中選擇更符合標準的研究設計,也刊登在較為知名的期刊。這樣的結果與過去研究呈現不一致,接受企業資助的研究相較於未接受資助者更符合學術上所認定較為理想的標準。本研究分析方法無法去證實或了解研究目的中系統性偏誤的存在,其可能因素不單只是顯示出企業資助不會影響到學術研究的可能性而已;必須進一步質疑的是,對於整個研究流程而言是否存在本身系統偏誤的問題。需要建立新的框架,以分析現有框架無法解釋的問題。
Subjects: Industry-sponsored research is a more and more usual phenomenon, especially in the relationship between pharmaceutical factories and industry-clinical trials research. In fact, a pharmaceutical factory needs research to make sure the patent right and profits and also, researchers need to catch on the source of their research funds. There are some problems between the supply-demand structures. That is, if the research process and outcomes will be influenced by industry-sponsor. The main subjects of our research are two: first, we want to know if the research designs, publication types, and research conclusions have specific research process deviations even have systematic bias because of pharmaceutical factories- and industry- sponsor ? Second, with the above-mentioned, if the specific deviations of research design or publication types would influence the research conclusions ?

Methods: By using the Medical Electronic Periodical Databases, we collected the publication data of clinical trial researches of the Orlistat, a weight loss drug, from the period between year two thousand to year two thousand and seven. The variables in our research included research subjects, research designs, research conclusions, and research publication types. The relationship analysis between the said variables and industry-sponsored situations have been conducted for understanding the impacts of researches with industry-sponsor.

Outcomes: In our research, there is no apparent relationship between industry-sponsored situations and research subjects, between industry-sponsored situations and research conclusions. The research design in researches which accepted industry-sponsor had a inclination to using blind research design, placebo control and had a higher rate of accomplish of the people included in our research. It suggested that the researches which accepted industry-sponsor would follow the standard clinical trial design compared to the researches don’t had industry-sponsor.
With the publications which accepted industry-sponsor, there are apparent deviations to the journals which display the conflict of interest and publication on the early date.
For the research designs and research conclusions, the relationship only between special research design and research conclusions, between the health status of the people included in research and the research conclusions.

Conclusions: Our research suggested that there is no apparent relationship between the industry-sponsored situations and the direction of research conclusions. The research which accepted the industry-sponsor would followed the standard research design and would published in the famous journals. That is, the ideal research would be the research that accepted industry-sponsor.
The restrict to our research is that, we cann’t prove or understand the fundamental factors of systematic bias of research design. That is to say, we need to build up a new framework for explaining the problems of systematic bias during the research process.
摘 要 I
Abstract II
致謝 IV
表 目 錄 VII
圖 目 錄 IX
第一章 研究背景與研究目的 1
第一節 研究背景與動機 1
第二節 研究目的 2
第二章 文獻探討 4
第一節 臨床試驗與研究資助 4
1-1 臨床試驗 4
1-2 研究資助 6
1-3 利益衝突(Conflict of interest)問題與解決方式 7
1-3-1 利益衝突 7
1-3-2 解決方式 9
第二節 企業資助與研究客觀性 10
2-1 研究目的/研究結論 10
2-2 研究發表 11
2-3 研究設計 12
2-3-1 等價或等量試驗(Equivalence trial) 13
2-3-2 階層設計(factorial design) 14
2-3-3 使用群或叢集隨機 14
2-3-4 交叉設計(Crossover Design) 14
2-3-5 在組間的非隨機設計 15
2-3-6 控制(對照組)組選擇 15
2-3-7 介入 16
2-3-8 結果測量 16
2-3-9 選擇參與者 16
2-3-10 隨機與盲目 17
第三節 小結 18
第三章 研究架構與分析方法 21
第一節 研究架構與研究假說 21
1-1 研究架構 21
1-2 研究假說 23
第二節 研究設計 23
2-1 資料收集 24
2-1-1 研究對象:減重藥物羅氏鮮 24
2-1-2 資料來源 25
2-1-3企業資助與期刊刊登政策 25
2-2 研究變項與資料分析 27
2-2-1 研究變項 27
2-2-2分析方法 30
第四章 研究結果 32
第一節 研究資助與研究目的╱研究結論 32
1-1 研究資助與研究目的 32
1-2 研究資助與研究結論 35
第二節 研究資助╱研究結論與研究設計 36
2-1 研究資助與研究設計 36
2-2 研究設計與研究結論 38
第三節 研究資助與研究發表 40
第四節 研究資助與研究變項多變項分析 41
第五章 討論 44
第一節 企業資助研究與結論 44
第二節 研究設計與研究結論 45
第三節 企業資助透明與規範 47
第六章 結論 49
第一節 企業資助研究的重新思考 49
第二節 研究限制 50
參考文獻 79
英文文獻 79
中文文獻 81
參考文獻
英文文獻
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中文文獻
王瑞蓮,新藥實用手冊:臨床研究、設計、執行和分析,合記圖書出版社,2002。
臨床試驗登記。民98年5月15日,取自台灣藥品臨床試驗資訊網:http://www.cde.org.tw/ct_taiwan/index.htm.
學術統計資料庫。民98年6月20日,取自行政院國家科學委員會網頁:https://nscnt12.nsc.gov.tw/WAS2/academia/AsAcademia.aspx.
醫療法。民98年6月20日,取自行政院衛生署網頁:http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT0201.asp.
葉嘉新、林志六,新藥開發與臨床試驗,秀威資訊科技股份有限公司,2008。
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