浅谈真实世界证据在抗肿瘤药品生命周期管理中的作用

Views on the role of real-world evidence in lifecycle management of oncology drugs

药品的生命周期包括初期的基础研究、上市前临床研究和上市后销售等阶段。随着真实世界证据概念的提出和真实世界数据处理技术的发展,真实世界证据在药品生命周期管理中的作用开始受到关注和重视,目前多国药品监管机构均倾向于允许将真实世界证据用于罕见病和某些肿瘤治疗药品的监管决策支持。本文介绍国内外抗肿瘤药品的真实世界研究现状,从药品的临床开发、审评审批和上市后研究3个方面探讨如何利用真实世界证据强化抗肿瘤药品的生命周期管理,同时对我国真实世界研究的未来发展进行展望。

The lifecycle of a drug consists of initial basic research,pre-marketing clinical research,and post-market surveillance.With the development of regulatory advice and technical guidelines on real-world evidence(RWE)and realworld data,the role of RWE in drug lifecycle management has gained broad attention and acceptance.Multiple official agency guidelines favor the use of RWE for regulatory decision support in the field of rare diseases and oncology drugs.This article summarizes the current situation of worldwide real-world studies on oncology drugs and discussew how to use real-world data to provide impetus for R&D,marketing and application of oncology drugs in its lifecycle from the aspects of clinical development,drug approval,marketing and post-marketing research and meanwhile looks into the future development of real-world research in China.