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目的探讨不同的操作模式对于临床试验执行的效率及质量的差别。方法选择由同一申办者在我院内分泌科同期发起的2个临床试验项目作了相关指标的回顾性分析。项目A(艾塞那肽治疗非胰岛素依赖型糖尿病的多中心、随机、对照研究)采用授权专人随访模式,项目B(特立帕肽治疗绝经期妇女骨质疏松症的多中心、随机、对照研究)则采用全科参与模式,每个研究者负责随访自己招募的受试者。从2个项目的基本概况,入组的速度、对GCP法规的符合要求、项目执行情况规范性等方面进行比较。结果 2个项目基本文档的保存,例如药物管理、温控记录、血标本记录、伦理审查情况、跟踪审查、邮件往来等文件齐全,差异未见统计学意义。但是从GCP要求来看,对研究病历、CRF表填写的规范性及相关的事件的处理,如方案偏离、SAE等,模式A执行优于模式B。结论随访授权专人能减少大部分医师的工作量,研究助手对于项目流程及GCP要求也更熟悉,对项目进度也能更好地把控,原始数据的收集及誊抄也会更及时。
Objective To explore the differences in the efficiency and quality of different operation modes for clinical trial implementation. Methods Select the same sponsor in our hospital endocrinology initiated two clinical trial projects made a retrospective analysis of relevant indicators. Item A (multicentre, randomized, controlled study of exenatide for non-insulin dependent diabetes mellitus) was conducted using an authorized person-to-person mode of follow-up and Project B (a multicenter, randomized, controlled trial of teriparatide for the treatment of osteoporosis in postmenopausal women Research) uses a generalized participatory approach whereby each investigator is responsible for following up on the subjects that they themselves recruited. The basic situation of the two projects, the speed of entering the group, the compliance with the GCP regulations and the normative nature of the project are compared. Results The preservation of basic documents such as drug management, temperature control records, blood sample records, ethical review, follow-up examination and mail correspondence between the two projects were complete and the differences were not statistically significant. However, according to the requirements of GCP, Mode A performs better than Mode B in terms of studying medical history, handling of normative CRF forms and related events such as scenario deviations and SAE. Conclusion The follow-up authorized persons can reduce the workload of most physicians. The research assistants are also more familiar with the project process and GCP requirements. They can also control the progress of the project and collect and copy raw data more timely.