Song Fuyu, Qian Xue, Li Jianming, Chow Shein-Chung, Hong Minghuang
1 Center for Food and Drug Inspection, China Food and Drug Administration, Beijing, China.
2 Duke University School of Medicine, Durham, NC, USA.
Ther Innov Regul Sci. 2019 May;53(3):374-380. doi: 10.1177/2168479018769887. Epub 2018 Jun 18.
Regulatory inspection of clinical trial is necessary in order for (1) assessing compliance with statutory requirements and regulatory requirement governing the conduct of clinical trials and (2) verifying the accuracy and reliability of clinical trial data submitted to regulatory agencies such as the United States Food and Drug Administration (FDA) in support of research or marketing applications. This article provides an overview of clinical inspection process and issues that are commonly encountered during the conduct of clinical trials. In addition, a couple of sampling plans for clinical inspection of relatively large trials are proposed. The proposed statistical process for clinical inspection that will achieve a desired degree of inspection accuracy and reliability is useful when the resources of inspectors are limited. The proposed 2-stage sampling plan can be applied to clinical inspection for multicenter and/or multinational multicenter clinical trials.
对临床试验进行监管检查是必要的，以便：（1）评估临床试验开展过程中对法定要求和监管要求的遵守情况；（2）核实提交给美国食品药品监督管理局（FDA）等监管机构以支持研究或上市申请的临床试验数据的准确性和可靠性。本文概述了临床试验检查过程以及临床试验开展过程中常见的问题。此外，还针对相对大型试验的临床试验检查提出了几种抽样方案。当检查人员资源有限时，所提出的能达到期望检查准确性和可靠性程度的临床试验统计检查流程是有用的。所提出的两阶段抽样方案可应用于多中心和/或跨国多中心临床试验的临床检查。
