去中心化药物临床试验实施模式和合规关注点讨论  

Discussions about application mode and compliance focuses for decentralized clinical trials

作　　者：陈一飞 董文彬 孙搏 张静[3] 涂勇 龚瑛 李刚 CHEN Yi-fei;DONG Wen-bin;SUN Bo;ZHANG Jing;TU Yong;GONG Ying;LI Gang(Shanghai Center for Drug Evaluation and Inspection,SHANGHAI 201203,China;School of Pharmacy,Fudan University,SHANGHAI 201203,China;Pfizer(China)Research and Development Co.,Ltd.,SHANGHAI 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203 [2]复旦大学药学院,上海201203 [3]辉瑞(中国)研究开发有限公司,上海201203

出　　处：《中国新药与临床杂志》2023年第8期507-513,共7页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：在以患者为中心的药物开发理念指导下,去中心化药物临床试验可以帮助降低受试者负担,受到各方关注。随着数字化技术的进步,去中心化药物临床试验实施模式已逐步进入实践应用,例如远程药物直达患者、使用穿戴设备收集数据等。与任何形式的药物临床试验一样,在去中心化药物临床试验实施中,受试者的伦理保护是前提,保障数据的可靠性是基础。在合规性考量中,去中心化药物临床试验较传统试验有更强的地域差别性,需要充分调研法规基础与诊疗实际。在试验设计中,新的设计元素存在实践经验少、风险未充分暴露等挑战,因此要求以对试验药物研究的质量因素识别为基础,通过质量设计,保障数据可靠性以支持药物评价。由于在其实施中可能涉及多个研究场地、更多的第三方和技术支持角色参与,所以去中心化药物临床试验的质量管理需要以先进的质量管理体系理念,通过风险管理和问题管理,保障复杂试验系统以符合预期的方式运行。With the patient-centered drug development principle,the decentralized clinical trials(DCT)have attracted increasing worldwide attentions by providing trial participants with convenience and comfort.With the development of digital technology,certain DCT models have been implemented,such as drug direct to patients,data collecting via wearable devices.The same with conventional clinical trials,participants'protection and data integrity are fundamental requirements in DCT.On the other hand,compliance is more complicated in DCT than in conventional trials since DCT has bigger geographical differences than traditional trials.Understanding the regulation requirement and practical clinical procedure is required for DCT implementations.Due to lack of experience and inadequate risk revelation,innovative DCT models are facing the challenges of protocol design.Consequently,scientific and risk-based study design should be based on the critical quality factors of investigational drugs to ensure data is adequate for drug evaluation.Since multiple study locations may be involved when conducting DCT,there will be more contract research organizations and technical supporting roles needed than conventional clinical trials.Therefore,an advanced quality management system,which includes risk management and issue management,is required for the DCT to be implemented as expected.

关 键 词：临床试验 研究者-受试对象关系 数据收集 去中心化临床试验 监管科学 合规 

分 类 号：R95[医药卫生—药学]