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"政用产学研"视角下药物临床试验机构与合同研究组织协同发展的初探 被引量:2

Preliminary study on the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of"government-application-industry-academia-research"
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摘要 目的在"政用产学研"视角下,探讨药物临床试验机构与合同研究组织(CRO)如何协同发展,以促进临床试验更好、更快地进行。方法本文通过文献学习,结合作者在药物临床试验管理中的工作实践,系统总结了临床试验实施过程中存在的问题,借鉴"政用产学研"模式,探讨药物临床试验机构与合同研究组织如何协同发展。结果临床试验实施过程中存在CRO水平参差不齐、缺乏有效的监管部门以及与药物临床试验机构不能充分合作等问题,导致临床试验资源无法共享,影响临床试验质量。并建议从以下几方面加强临床试验机构与CRO的协同发展:用好政府的"有形之手"加强对CRO的监管;加快建设药物临床试验机构与CRO的创新联盟;建立协同发展的激励机制与人才梯队并重的培养模式;加强专业性人才队伍的培养。结论可以尝试将"政用产学研"的模式应用于临床试验中,促进药物临床试验机构与CRO协同发展,推进临床试验事业健康发展。 Objective To explore the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of"government-application-industry-academia-research",and facilitate faster and better conducting of clinical trials.Methods Based the combination of literature review and the working practice in drug clinical trial management,problems existed during the implementation of clinical trials were summarized,and then the collaborative development of drug clinical trial institutions and Contract Research Organizations were discussed from the perspective of"government-application-industry-academia-research"partnership.Results Problems identified during the implementation of clinical trials including uneven capacity of CROs,lack of effective supervision department and insufficient cooperation with clinical trial institutions,which resulted difficulties in sharing clinical trial resources and also negatively impacted the quality of clinical trials.Some proposals were offered in this article,including making good use of the"visible hand"of the government to strengthen the supervision of CROs,accelerating the construction of innovation alliance between clinical trial institutions and CROs,establishing the incentive mechanism of collaborative development and the talent team construction,strengthening the personnel professional training.Conclusions The application of"government-application-industry-academia-research"model in clinical trials would promote the collaboration between drug clinical trial institutions and Contract Research Organizations,which play important roles in the development of clinical trials.
作者 孔敏 高熹 季晓慧 朱露莎 李进冬 林梅 Kong Min;Gao Xi;Ji Xiaohui;Zhu Lusha;Li Jindong;Lin Mei(Scientific Research Department of the Fifth Affiliated Hospital of Nantong University(Taizhou People′s Hospital),Taizhou 225300,Jiangsu Province,China)
出处 《中华医学科研管理杂志》 2021年第6期407-411,共5页 Chinese Journal of Medical Science Research Management
基金 泰州市软科学研究计划项目(RKX202008) 泰州市人民医院创新团队(CXTDA201901)。
关键词 政用产学研 临床试验机构 合同研究组织 协同发展 Government-application-industry-academia-research Clinical trial institution Contract research organization Collaborative development
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