基于药品管理探讨研究者发起的儿科药物临床研究实施风险及对策  

Discussion on implementation risks and countermeasures of investigator-initiated pediatric drug clinical trials based on drug management

作　　者：叶朝辉 严荧燕 朱卓儿 陈漪 Ye Chaohui;Yan Yingyan;Zhu Zhuoer;Chen Yi(Women and Children′s Hospital of Ningbo University,Ningbo 315012,Zhejiang Province,China)

机构地区：[1]宁波大学附属妇女儿童医院,315012

出　　处：《中华医学科研管理杂志》2024年第5期424-428,共5页Chinese Journal of Medical Science Research Management

基　　金：宁波市重点学科儿科学(2022-B17);宁波市医疗品牌学科-儿科重症学(PPXK2024-06)。

摘　　要：目的从研究药品管理探讨研究者发起的儿科药物临床研究实施风险并提出相关建议,以提高儿科临床研究的规范和质量。方法通过查阅文献资料和法律法规,结合项目管理中出现的研究药品相关问题,讨论国内研究者发起的儿科药物临床研究实施过程中的风险点并提出对策建议。结果研究者发起的儿科药物临床研究中,研究药品来源多样,包括赞助方赠药、医院药房供应和社会药房供应,带来了不同的管理风险,需要特别关注。同时,研究执行过程中儿科用药特有的风险点也需充分关注。医疗机构应加强研究药品的全流程管理,确保研究顺利进行。结论研究者发起的儿科药物临床研究是对儿童新药临床试验的补充和延展,医疗机构积极开展的同时,建议从药品供应、受试者补偿和儿童剂型等角度加强立项审查,实施研究药品中心化管理,重视药品不良事件伦理审查,加强人员培训及采用信息化结算,从而提高工作效率和研究质量,为我国儿童用药研发和儿科医学高质量发展提供助力。ObjectiveThis study aimed to discuss the risks associated with investigator-initiated pediatric drug clinical trials in terms of drug management and put forward relevant suggestions to improve the standardization and quality of pediatric clinical trials.MethodsThe risk in the implementation of pediatric drug clinical trials initiated by domestic researchers were discussed and the countermeasures were put forward by reviewing literature,laws and regulations,and combining with the problems related to research drugs in project management.ResultsIn investigator-initiated pediatric drug clinical trials,the variety of research drug sources,such as sponsor donations,hospital pharmacy supplies,and community pharmacy provisions,posed distinct management risks that would require tailored attention.Moreover,the specific risk of pediatric medication should be fully considered during study execution.It was imperative for medical institutions to strengthen comprehensive management of research drugs to ensure the trial′s smooth operation.ConclusionsInvestigator-initiated pediatric drug clinical trials serve as valuable supplements that expand new drugs′trial scope for children.While actively conducting these trials,it is recommended that medical institutions should strengthen project approval reviews from the perspectives of drug supply,subject compensation and child dosage form,implement centralized management of research drugs,attach importance to ethical review of adverse drug events,strengthen personnel training and leverage information settlement,so as to improve work efficiency and research quality-ultimately providing support for pediatric pharmaceutical development efforts as well as promoting high-quality advancements within Chinese pediatrics medicine.

关 键 词：研究者发起 药物临床研究 药品管理 儿科 

分 类 号：R95[医药卫生—药学]