基于儿童人群特点的临床试验风险控制模型的建立

Establishment of risk control model of clinical trial based on characteristics of pediatric population

目的建立基于儿童人群特点的临床试验风险控制模型。方法对近年开展的儿童临床试验项目风险点进行分析,编订、修订管理制度和标准操作规程(standard operating procedure,SOP),运用风险管理的方法开展研究。结果《临床试验项目风险识别、预估、评估表》为儿童临床试验设计提供了参考依据。结论初步建立的基于儿童人群特点的临床试验风险控制模型,可有效地减少儿童临床试验风险的发生,起到保护儿童受试者、规范临床试验操作流程的作用,可提高研究者参与临床试验的积极性。

Objective To establish a risk control model for clinical trials based on the characteristics of paediatric populations. Methods The risk points of children＇s clinical trials in recent years were analyzed. The management systems and Standard Operating Procedures（SOP） were formulated and modified, and risk management methods were used to conduct research. Results The ＂Clinical Trial Project Risk Identification, Prediction, and Evaluation Form＂ provided a reference for the design of clinical trials in children. Conclusion The preliminarily established clinical trial risk control model based on the characteristics of paediatric populations can effectively reduce the risk of children＇s clinical trials, play a role in protecting children＇s subjects, standardize the clinical trials＇ operating procedures, and increase the enthusiasm of researchers to participate in clinical trials.