摘要
目的 兼顾研究者、伦理委员会、研究机构科研管理部门的管理要求及工作量,平衡管理及减少方案偏离事件的发生,探讨研究者发起的临床研究方案偏离事件的管理策略.方法 分析研究者发起的临床研究中方案偏离事件表现形式、发现途径、主要原因及分类标准等方面问题.结果 结合当前方案偏离管理现状及笔者实践探索,从质量源于临床研究设计、研究者自我评估影响程度后上报、强化研究机构ⅡT临床研究质量管理体系建设、持续加强培训与宣教、探索基于注册类临床试验差异的ⅡT方案偏离评价判断标准等5个方面提出应对方案偏离问题的管理对策.结论 方案偏离在临床研究的开展过程中难以避免,但研究者、研究机构应分清方案偏离的性质、程度、影响及根本原因,有效纠正与采取改进措施,减少方案偏离事件的发生,提高研究的质量与效率.
Abstract
Objective To explore the management strategies for investigator-initiated trail protocol deviations events with comprehensive consideration of the management requirements and workload of researchers,ethics committees,and research management departments,and balancing the management while reducing the occurrence of protocol deviations.Methods Mani-festations,discovery approaches,main causes,and classification criteria of protocol deviation events in investigator-initiated trials were analyzed.Results Based on the current status of protocol deviation management and the author's practice,this arti-cle proposed management countermeasures to deal with the problem of protocol deviation in five aspects:quality originates from the clinical study design,researcher's self-assessment and reporting,strengthening the construction of ⅡT quality management system,continuously promoting training and education,and issuing classification and evaluation standards for ⅡT deviations.Conclusions Protocol deviation is unavoidable in the process of clinical research,but researchers and institutions should distin-guish the nature,degree,impact,and causes of protocol deviation,effectively correct and take measures to reduce the occur-rence of protocol deviation events,and improve the quality and efficiency of research.
基金项目
深圳市科技创新委可持续发展专项(KCXFZ20230731094903006)
广东省医学科学技术研究项目(B2023372)
NETL
NSTL
万方数据