中国临床药学杂志

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。

AIM To explore the difference in efficiency and quality of clinical trials between two operation modes. METHODS We selected two protocols sponsored by the same drug company in the department of endocrinology in our hospital,these two protocols almost carried out in the same period and we collected the data conducting the retrospective analysis. Protocal A: a multi-center,randomized,controlled study of the treatment of noninsulin-dependent diabetes mellitus with exenatide. The protocol autrorized research assisstant to follow up the subjects. Protocal B: teriparati-de treatment of postmenopausal osteoporosis,a multi-center randomized controlled study. In this protocol,all the investigators were authorized and everyone follow up the subject screened by themselves. We analized the difference in situation of GCP compliance,the speed of enrollment between two protocals. RESULTS There was no difference in drug administration,temperature recording,initial review,continuing review,email communication. But from the need of GCP regulation,such as recording the data in CRF,dealing with SAE and deviation of the protocol,protocol A was much better than protocol B. CONCLUSION Authorizing the research assisstant to follow up the subjects can decrease most work of the investigators and research assistant usually be more familiar to the protocol and GCP regulation,he / she can be better to control the process of the clinical trial,and collect the source data and fill in CRF on time.