临床研究设计方案要点之药品上市后再评价研究不良事件的管理

Key point of clinical research protocol design——management of adverse event in post-marketing drug evaluation

药品关系到人民群众的身心健康,其安全性极为重要。药品上市前临床试验的局限使其并不能完全反映药物的安全性,故开展药品上市后再评价对于进一步评价药物的安全性有着积极的意义。药品上市后再评价时最重要的内容是安全性评价即不良反应评价,最主要的研究方法是真实世界研究,实施的关键则是制定管理计划。本文介绍了相关法律法规以及如何制定合理有效的管理计划。

Drugs play important roles in citizens＇ physical and mental health. Pre-marketing trials have certain limitations resulting in incomplete safety profies; therefore, post-marketing drug evaluation is essential for further safety evaluation. Assessment of adverse reactions represents the most important measurement, the key approach and implementation element of which is the real world research and determination of management plan, respectively. In this paper, we discussed relevant laws and regulations, and ways to form an adequate management plan.