简析在学术型临床研究中研究者加强随访管理的策略

Research on strategies for academic clinical research investigators strengthening follow-up management

目的通过北京大学临床研究所管理的学术型临床研究发现,研究者在涉及随访的临床研究中存在管理方面的问题,透过分析对这些问题提出相应的解决策略和方法,以提高临床研究中随访质量;方法在项目管理和现场监查方面对常见问题进行原因分析;结果提出加强解决研究者随访管理的策略和指导意见,并给出随访过程实施的表格工具及管理软件;结论临床研究要求研究者在研究过程中遵循试验的科学性、策略和方法,以提高随访率和保障数据质量,从而降低临床研究的不依从事件。

Objective According to the study of academic clinical research managed by Peking University Clinical Research Institute, identified problems that existed during the follow up in clinical research. Strategies and methods were proposed after analyzed the related problems, to enhance the quality of follow-up in clinical research. MethodsAnalysis of common follow-up management problems found in project management and on-site monitoring. Results Strategies and suggestions were proposed, table tools and management software were recommended to investigators for strengthening follow-up management. Conclusions Investigators should follow the scientific validity, research strategy and methodologies during the implementation of clinical research, to make sure compliance to increase the follow-up rates and guarantee the data quality.