本文選題：藥物臨床試驗 + 法律監(jiān)管　； 參考：《福州大學(xué)》2014年碩士論文

【摘要】：藥物臨床試驗作為一個高度專業(yè)化的領(lǐng)域,對人體存在未知的風(fēng)險性,同時,試驗的申辦者和研究者可能為了自身的經(jīng)濟(jì)利益而違規(guī)操作甚至忽視受試者的安全利益。因此,梳理我國有關(guān)藥物臨床試驗監(jiān)管的法律法規(guī),分析我國有關(guān)藥物臨床試驗監(jiān)管的不足并提出相應(yīng)的完善措施,對于健全我國的相關(guān)法律制度、加強(qiáng)對受試者的權(quán)益保護(hù)都具有非常重要的現(xiàn)實意義。論文共分為三部分。第一部分介紹了藥物臨床試驗法律監(jiān)管的概念、經(jīng)濟(jì)學(xué)基礎(chǔ)、法律價值和基本原則。藥物臨床試驗法律監(jiān)管作為政府監(jiān)管的一種,是指藥品監(jiān)督管理部門為矯正市場失靈、保障公民用藥安全,依據(jù)法律的授權(quán),在職權(quán)范圍內(nèi),運(yùn)用藥事法律法規(guī)和政策、國家藥品標(biāo)準(zhǔn)對藥品研發(fā)過程進(jìn)行的藥物臨床試驗采取的干預(yù)和控制的活動。信息不對稱理論、市場失靈與政府干預(yù)理論是藥物臨床試驗法律監(jiān)管的經(jīng)濟(jì)學(xué)基礎(chǔ)。藥物臨床試驗法律監(jiān)管在法律價值方面應(yīng)突出秩序價值、人權(quán)價值和公平價值,其基本原則包括受試者利益第一原則,尊重個人原則,比例原則和科學(xué)性原則四個方面。第二部分梳理我國對藥物臨床試驗監(jiān)管的立法現(xiàn)狀并剖析其存在的不足。由于我國藥物臨床試驗的歷史發(fā)展較晚,雖然法律監(jiān)管制度經(jīng)歷了從無到有、從不規(guī)范到規(guī)范的過程,但是仍面臨著不少問題,與國外發(fā)達(dá)地區(qū)相比,還存在很大的差距。存在的問題主要包括三大方面,一是國家監(jiān)管部門對藥物臨床試驗監(jiān)管存在缺陷,包括申請審批時限長；缺乏與申辦者的交流機(jī)制,對申辦者的處罰措施過輕,沒有對研究機(jī)構(gòu)和研究者財務(wù)方面的監(jiān)管規(guī)定,缺少對倫理委員會的監(jiān)管規(guī)范。二是倫理委員會缺乏獨立性,不利于發(fā)揮倫理委員會的監(jiān)管職責(zé)；三是申辦者對藥物臨床試驗的監(jiān)管規(guī)范不完善�！胧刮覈幬锱R床試驗規(guī)范有序的進(jìn)行,受試者的合法權(quán)益得到有效保障,就必須有效監(jiān)管藥物臨床試驗,完善相關(guān)的法律法規(guī)。論文的最后一部分提出了完善我國藥物臨床試驗法律監(jiān)管的對策措施,首先,對于國家對藥物臨床試驗法律監(jiān)管而言,應(yīng)縮短審批時間,建立與申辦者的會議溝通機(jī)制,加重對申辦者的處罰措施,完善對研究者告知義務(wù)和財務(wù)狀況的監(jiān)管,建立倫理委員會的注冊認(rèn)證制度和跟蹤審查制度；其次,建立區(qū)域性倫理委員會,保證倫理委員會的獨立性和公正性；最后,完善申辦者對藥物臨床試驗的監(jiān)查和稽查制度。
[Abstract]:As a highly specialized field, drug clinical trials have unknown risks to human body. At the same time, the applicants and researchers may violate the rules and even ignore the safety interests of the subjects for the sake of their own economic interests. Therefore, by combing the laws and regulations concerning the supervision of clinical trials of drugs in China, analyzing the deficiencies of the supervision of clinical trials of drugs in China and putting forward corresponding measures to improve the relevant legal system of our country, It is of great practical significance to strengthen the protection of the rights and interests of the subjects. The paper is divided into three parts. The first part introduces the concept, economic basis, legal value and basic principles of legal supervision of drug clinical trials. As a kind of government supervision, the legal supervision of drug clinical trials refers to the application of pharmaceutical laws, regulations and policies by drug regulatory departments in order to correct market failures and ensure the safety of drug use by citizens, in accordance with the authorization of the law and within the scope of their functions and powers. National Drug Standards intervention and control activities for drug clinical trials conducted during drug development. The theory of information asymmetry, market failure and government intervention is the economic basis of the legal supervision of drug clinical trials. The legal supervision of drug clinical trial should emphasize the value of order, human rights and fairness in the aspect of legal value. Its basic principles include the principle of subject interests first, the principle of respecting individual, the principle of proportion and the principle of science. The second part combs the current situation of our country's legislation on the supervision of drug clinical trials and analyzes its shortcomings. Because of the late development of the history of drug clinical trial in our country, although the legal supervision system has experienced the process from nothing to existence, from non-standard to standard, it still faces many problems, and there is still a big gap compared with the developed regions abroad. The existing problems mainly include three major aspects: first, the state regulatory authorities have defects in the supervision of clinical trials of drugs, including the long time limit for application and approval; the lack of communication mechanism with the applicants; and the lenient punishment measures imposed on the applicants. There are no financial regulations for research institutions and researchers, and no regulation for ethics committees. The second is the lack of independence of the ethics committee, which is not conducive to giving full play to the supervision function of the ethics committee; the third is the imperfect regulatory norms of the applicant for the clinical trial of drugs. If we want to make the clinical trials of drugs in our country carry out in an orderly manner and ensure the legal rights and interests of the subjects, we must effectively supervise the clinical trials of drugs and perfect the relevant laws and regulations. In the last part of the paper, the author puts forward the countermeasures to improve the legal supervision of drug clinical trials in China. Firstly, the examination and approval time should be shortened and the meeting communication mechanism should be set up with the applicants for the legal supervision of drug clinical trials. To increase the penalty measures for the applicants, to improve the supervision of the researcher's obligation to inform and the financial situation, to establish the registration and certification system of the ethics committee and the tracking and examination system; secondly, to establish the regional ethics committee. To ensure the independence and impartiality of the ethics committee; finally, to improve the monitoring and inspection system of drug clinical trials.
【學(xué)位授予單位】：福州大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：D922.16

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