临床试验生物样本管理的现状与挑战

Current Status and Challenges of Biological Sample Management in Clinical Trials

随着临床试验的快速发展,基于生物样本开展的相关医学研究和分子检测与临床试验的进展紧密关联,使得生物样本在临床试验中的作用愈发明显,其规范化的监管模式是开展高质量临床试验的重要前提。尽管与临床试验相关的法律法规日趋完善,但仍有大量的与生物样本相关的不良事件发生,严重影响临床试验的进展与结果,是当前面临的重要挑战之一。因此,亟须强化对生物样本的监管,完善现阶段临床试验中生物样本的管理方式。通过深入探讨国内外临床试验中生物样本的管理现状,分析生物样本监管过程中存在的问题,进一步梳理现有的相关政策法规和《临床试验生物样本伦理管理指南》对生物样本管理的新补充,为优化临床试验生物样本的管理模式提供建议与思考。

With the rapid development of clinical trials,the relevant medical research and molecular detection based on biological samples are closely related to the progress of clinical trials,making the role of biological samples in clinical trials increasingly obvious.The standardized supervision mode of biological samples is an important prerequisite for carrying out high-quality clinical trials.Although the laws and regulations related to clinical trials are becoming more and more perfect,there are still a large number of adverse events related to biological samples,which seriously affects the progress and results of clinical trials,and is one of the important challenges currently facing.Therefore,it is urgent to enhance the supervision of biological samples and improve the management methods of biological samples in clinical trials at this stage.Through in-depth discussion of the current status of biological sample management in clinical trials at home and abroad,this paper analyzed the issues existed during the supervision of biological samples,and supplemented the biological sample management methods by further combing the existing relevant laws and regulations and the Guidelines for the Ethical Management of Biological Samples in Clinical Trials,with a view to providing suggestions and ideas for optimizing the management mode of biological samples in clinical trials.