药学服务相关研究者发起的临床研究设计与实践心得

Pharmacy Services-related Investigator-initiated Trial Research Design and Practical Experiences

目的探讨药学服务相关研究者发起的临床研究(investigator-initiated trial,IIT)的设计与实施策略,提升药师的研究能力,为后期开展研究的药师提供参考。方法分析国内外药学服务相关IIT文献与注册研究,并结合浙江省人民医院药师开展药学服务相关IIT研究的探索经验,总结主题确立、结局指标、样本量估算、随机化、质控和总结报告等关键环节的注意事项以及经验。结果IIT是临床研究的重要组成部分,科学严谨的方案设计和规范的实施管理是高质量IIT的重要前提。结论在药学服务中发现临床问题,药师运用科研思维发起IIT研究,将成果转化为临床应用,推动药学服务的高质量发展。

OBJECTIVE To explore the design and implementation strategies of investigator-initiated trial(IIT)studies related to pharmaceutical services,enhance the research capabilities of pharmacists,and provide a reference for pharmacists who will conduct research in the future.METHODS Analyzed domestic and international pharmaceutical service-related IIT literature and registered studies,and combined with the experience of pharmacists in carrying out IIT research,and summarize the matters needing attention and experience in key links such as theme establishment,outcome indicators,sample size estimation,randomization,quality control and summary report in Zhejiang Provincial People's Hospital.RESULTS IIT is an important part of clinical research,scientific design and standardized implementation were important prerequisites to ensure the authenticity and reliability of research results.CONCLUSION In pharmaceutical services,pharmacists identify clinical issues and initiate IIT research with a scientific mindset.Transforming research findings into clinical applications promotes the high-quality development of pharmaceutical services.