药物临床试验数据可靠性要求探讨

Discussion on Data Integrity in Drug Clinical Trials

药物临床试验是药品研发过程中的关键环节,是药品审评审批的重要依据。随着科技的发展,计算机化系统在药品研发过程中的应用愈加普遍,临床试验的实施从传统的纸质化逐步到电子化。本文介绍了药物临床试验中对数据可靠性的要求,以及不同计算机化系统的关注重点,旨在为国内新药研发和临床研究提供有益参考。

Drug clinical trial is a critical stage of drug development,and important basis for drug review and approval.With emerging technology,the use of computerized system has become increasingly common in drug research and development.Clinical trial went digitalized gradually.This paper introduced the data integrity issue in clinical trials and focus of different computerized systems,with the aim of providing information for the drug development and clinical research in China.