药物临床试验机构对临床试验中不良事件的监控

不良事件的监控是临床试验的关键环节之一,也是新药临床试验相关部门所关注的重点。目前国际上高水平的临床试验已经建立了较为完善的多方位的监控机制,国内还存在着较大的差距。由于药物临床试验机构对临床试验中不良事件的监控直接关系着受试者的安全和临床试验的质量,因此加强临床试验机构对不良事件的监控,才能最大限度地保障受试者的权益。本文结合作者所在单位的具体经验和体会,就如何加强临床试验中不良事件的监控力度提出了建议。

Controlling over drug adverse events in clinical trials by clinical trial organization

Controlling over adverse events is a key link of clinical trials with major importance for new drug trials clinically. Comparing to high level clinical trials aboard with perfect controlling mechanism, there is still a long way to catch up. For the safety of the tested subjects and promotion of the clinical trial, the controlling mechanism must be strengthened through the correlatire organizations. This article introduces the experiences and good suggestions of ours during recent years.