从药品技术审评谈临床试验的数据标准化

Interpreting standardization of clinical trial data from the perspective of drug technical review

申办者向药品审评机构递交的临床试验数据格式或结构千差万别,给审评人员带来巨大的挑战,需要花费大量的时间用于理解递交的数据。临床试验数据采纳CDISC标准已在国际药品监管机构(FDA,EMA,PMDA)达成一定的共识。本文主要从药品技术审评的角度,阐述CDISC标准对提高审评质量和效率所带来的促进意义,并对药品审评中心牵头启动的研究建立临床试验数据标准化专项工作进行简单介绍。

The clinical trial data submitted by sponsors varied in its formats or structures, bringing great challenges to the reviewers who had to spend plenty of time understanding these data. Consensus has been reached that CDISC standard should be adopted in drug regulatory agencies like US FDA, EMA and PMDA. From the view of drug technical evaluation, this paper illustrated the improvement value to the quality and efficiency of review by adopting CDISC standard, and briefly introduced the special work of study and establishment of clinical trial data standardization which is led by center for drug evaluation, CFDA.