法国BIA10-2474临床试验事件对我国研究者的启示

摘要

目的 通过对法国BIA 10-2474临床试验Ⅰ期研究首次人体试验事件的详细介绍,为我国从事创新药物临床试验Ⅰ期研究首次人体试验以及相关临床试验研究的研究者提供一些建议.方法采用案例分析法,以法国BIA10-2474临床Ⅰ期研究首次人体试验事件过程为案例进行了深入的分析.结果与结论 对于创新药物临床试验Ⅰ期研究首次人体试验或相关临床试验研究,我国研究者应该重视起始剂量的设计、对终止递增规则做出正确决策以及制定风险控制措施,最大程度地保证受试者的安全,提升整体临床研究水平.%Objective To provide some suggestions for the investigators who are engaged in phase Ⅰ clinical trial First-In-Human or related clinical trials in China through making a detailed introduction to the first human trial event in phase Ⅰ of French BIA 10-2474 clinical trial.Methods A case study was conducted to analyze the clinical phase Ⅰ study of BIA 10-2474 in France.Results and Conclusion To the first-in-human clinical trials,investigators in China should pay attention to the design of starting dose,making correct decision to terminate the incremental rule,setting up risk control measures,guaranteeing the safety of the subjects,enhancing the overall level of clinical research.