如何制定临床试验的数据和安全监察计划

在临床试验中实施数据和安全监察是为了确保参加临床试验的受试者安全和采集的数据有效、完整、准确,每一个临床试验都有必要制定数据和安全监察计划,并经伦理委员会批准。数据和安全监察计划的内容包括方案概要、试验管理、数据管理和分析、质量保证、法规、试验安全、试验的有效性、数据和安全监察计划的实施、必要时制定数据和安全监察委员会计划。制定数据和安全监察计划时需要考虑试验的风险、研究期、试验设计、干预研究的疾病/症状、研究人群、干预措施、终点/结果指标等,监察的程度需与试验的风险、规模和复杂程度一致。

How to make data and safety monitoring plans in clinical trials

The purpose of data and safety monitoring is to ensure the safety of subject and the validity,integrity and accuracy of the data in clinical trials. Data and safety monitoring plans （DSMP）,approved by Institutional Review Board （IRB）,is indispensable in clinical trials. DSMP consists of protocol outline,trial management,data management and analysis,quality assurance,regulations,safety,efficacy,DSMP execution,data and safety monitoring board plan （If desired）. The following aspects should be taken into account when making data and safety monitoring plans：e.g. study risk,study phase,trial design,disease/syndrome of the study,study population,study intervention,endpoints/outcome variables,et al. The monitoring degree depends on the risks,size and complexity of the trials.