风湿免疫科药物临床试验风险管控策略研究

Study on risk control strategies for clinical trials of drugs in rheumatology and immunology department

关键词:  风湿免疫科  药物临床试验  风险指标体系  标准操作规程  

Key words:  Rheumatology  Clinical trials  Risk indicator system  Standard operating procedures  

摘要:

目的 基于临床试验流程识别风湿免疫科临床试验开展过程中面临的风险点,为未来风湿免疫科开展药物临床试验风险管控工作提供参考。方法 收集质控报告、稽查报告、监查报告等,总结出124项风湿免疫科药物临床试验具体风险点。采用专家评价表,对各项风险点的发生概率和影响程度进行赋值评价。结果 设立三级风湿免疫科临床试验风险指标体系,总结124项风险点。筛选前10项作为关键风险点,其中数据记录与报告、管理制度/SOP两大部分是最容易出现风险与影响程度最大的两部分。 结论 本研究以风湿免疫科临床试验作为研究对象,构建风险指标体系,结合行业专家意见识别出关键风险点,同时标准操作规程的修订为主要风险管理措施,对完善风湿免疫科临床试验质量控制具有一定的实践参考价值。

Abstract:

ABSTRACT: OBJECTIVE To identify the risk points faced during the conduct of clinical trials in the Department of Rheumatology and Immunology based on the clinical trial process, and to provide a reference for the future risk control work of conducting drug clinical trials in the Department of Rheumatology and Immunology. METHODS Quality control reports, audit reports, supervision reports, etc. were collected to summarise 124 specific risk points of rheumatology and immunology clinical trials. The probability of occurrence and the degree of influence of each risk point were evaluated by assigning values using an expert evaluation form. RESULTS A three-level rheumatology clinical trial risk index system was set up to summarise 124 risk points. The top 10 items were screened as key risk points, of which the two main parts, data recording and reporting and management system/SOP, were the two parts with the highest probability of risk and the highest degree of influence. CONCLUSION This study takes clinical trials in rheumatology and immunology as the research object, constructs the risk index system, identifies the key risk points by combining the opinions of industry experts, and at the same time, the revision of SOP is the main risk management measure, which is of certain practical reference value for the improvement of the quality control of clinical trials in rheumatology and immunology.