摘要
近年来,主方案设计已被广泛应用于临床试验中。主方案设计可以在多种疾病中评估一种或多种干预措施的疗效,也可以在单一疾病中评估多种干预措施的疗效。篮式研究和伞式研究是主方案设计中最常应用的类型。本文将从背景、设计思路、案例解读等对这两种研究设计方法进行简单介绍。
In recent years,the master protocol design has been widely used in clinical trials,which can evaluate the efficacy of one or more interventions in multiple diseases or multiple interventions in a single disease.Basket and umbrella trials are the most used types in master protocol design.This article briefly introduces the background,design procedure,and case interpretation of basket and umbrella trials.
作者
张怡君
田雪
胥芹
张晓丽
王安心
ZHANG Yijun;TIAN Xue;XU Qin;ZHANG Xiaoli;WANG Anxin(National Clinical Research Center for Neurological Diseases,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;Department of Epidemiology and Health Statistics,School of Public Health,Capital Medical University,Beijing 100069,China)
出处
《中国卒中杂志》
2023年第2期240-243,共4页
Chinese Journal of Stroke
基金
“十四五”国家重点研发计划(2022YFC3600600)
北京市自然科学基金(L222123)。
关键词
篮式研究
伞式研究
Basket trial
Umbrella trial
