中国食品药品监管Issue(1)：36-47,12.DOI:10.3969/j.issn.1673-5390.2025.01.004
双特异性抗体抗肿瘤药物临床试验对照组选择的监管要求及案例分析
Regulatory Requirements and Case Analysis of Control Arm Selection in Clinical Trials of Bispecific Antibody Anticancer Drugs
杨雨 1邵雪1
作者信息
- 1. 普米斯生物技术(珠海)有限公司法规与药政策略部
- 折叠
摘要
Abstract
In drug clinical trials,the use of randomized controlled methodologies aims to demonstrate that new drugs have an acceptable benefit-risk profile compared to current standard-of-care treatments.However,studies have shown that some clinical trials for anticancer drugs have utilized suboptimal controls to gain market approval,failing to demonstrate improved patient outcomes over the best available standard therapies at the time.This may result in inefficiencies and waste of healthcare resources.Bispecific antibodies(BsAbs)are developed with the expectation of offering greater clinical advantages compared to monospecific antibodies(MsAbs).Consequently,selecting appropriate control arms in clinical randomized controlled trials of BsAbs is crucial,as this choice directly impacts the evaluation of the efficacy and safety of BsAbs and the verification of their development objectives.Regulatory authorities in both China and the United States have issued guidance documents addressing the development of BsAbs,providing recommendations to guide the industry and stakeholders.This article explores the regulatory requirements for selecting control arms in clinical trials of bispecific antibody anticancer drugs in China and the United States.It also provides case analyses to offer insights and references for the industry.关键词
双特异性抗体/抗肿瘤药物/对照组/监管要求/案例分析Key words
bispecific antibody/anticancer drug/control arm/regulatory requirements/case analysis分类
医药卫生引用本文复制引用
杨雨,邵雪..双特异性抗体抗肿瘤药物临床试验对照组选择的监管要求及案例分析[J].中国食品药品监管,2025,(1):36-47,12.
