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药物研发单位(申办者)和合同研究组织(CRO)是药物临床试验的发起者和组织者,是保证药物临床试验质量的关键。我国目前尚未建立申办者和CRO的监管措施和监督检查机制。本课题对国内外药物临床试验监管制度及对申办者和CRO的监管模式和实际监管情况进行了研究比较,收集了上海市自2008年实施药品注册临床试验现场核查以来的核查记录,并对上海市申办者、CRO和临床试验机构进行了调研访谈,对部分省市药品注册监管人员进行了访谈,以大量的研究数据为依据,深入分析了当前国内申办者和CRO开展药物临床试验的现状和执行GCP中存在的实际问题;借鉴国外比较成熟的临床试验监管经验,探讨了适合我国当前国情的对药物临床试验申办者和CRO的监管模式,以期完善国内的临床试验监管制度,保证国内药物临床试验质量,从而保障受试者权益和保证研究结果的科学可靠,并有助于推动国内制药企业走向国际化。
Drug R & D units (sponsors) and contract research organizations (CROs) are the sponsors and organizers of drug clinical trials and are key to ensuring the quality of drug clinical trials. At present, China has not yet established regulatory measures and supervision and inspection mechanism for sponsors and CROs. This issue of domestic and foreign drug clinical trial regulatory system and the sponsor and the CRO regulatory model and the actual regulatory situation were compared to collect the Shanghai since 2008, the implementation of drug registration clinical trial site verification since the verification records and Shanghai City sponsors, CROs and clinical trial institutions conducted interviews with drug regulatory regulators in some provinces and cities. Based on a large amount of research data, the current status of drug clinical trials conducted by domestic sponsors and CROs was analyzed. The implementation of the GCP in the practical problems; learn from the more mature clinical trial regulatory experience, suitable for China’s current national conditions for the drug clinical trial sponsor and CRO regulatory model, with a view to improving the domestic clinical trial regulatory system to ensure the domestic drug clinical Test quality, so as to protect the interests of subjects and ensure the scientific and reliable research results, and help to promote the domestic pharmaceutical companies to international.