With advancements in biomarkers and momentum in precision medicine, biomarker‐guided trials such as basket trials and umbrella trials have been developed under the master protocol framework. A master protocol refers to a single, overarching design developed to evaluate multiple hypotheses with the general goal of improving the efficiency of trial evaluation. One type of master protocol is the basket trial, in which a targeted therapy is evaluated for multiple diseases that share common molecular alterations or risk factors that may help predict whether the patients will respond to the given therapy. Another variant of a master protocol is the umbrella trial, in which multiple targeted therapies are evaluated for a single disease that is stratified into multiple subgroups based on different molecular or other predictive risk factors. Both designs follow the core principle of precision medicine—to tailor intervention strategies based on the patient's risk factor(s) that can help predict whether they will respond to a specific treatment. There have been increasing numbers of basket and umbrella trials, but they are still poorly understood. This article reviews common characteristics of basket and umbrella trials, key trials and recent US Food and Drug Administration approvals for precision oncology, and important considerations for clinical readers when critically evaluating future publications on basket trials and umbrella trials and for researchers when designing these clinical trials.

中文翻译：

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面向临床医生的精准肿瘤学篮子和伞状试验概述

随着生物标志物的进步和精准医学的发展势头，在主协议框架下开发了生物标志物引导的试验，例如篮式试验和伞状试验。主协议是指为评估多个假设而开发的单一总体设计，其总体目标是提高试验评估的效率。一种类型的主协议是篮子试验，其中针对多种疾病评估靶向治疗，这些疾病具有共同的分子改变或风险因素，可能有助于预测患者是否会对给定的治疗产生反应。主协议的另一个变体是伞形试验，其中针对一种疾病评估多种靶向治疗，该疾病根据不同的分子或其他预测风险因素分为多个亚组。这两种设计都遵循精准医学的核心原则——根据患者的风险因素定制干预策略，以帮助预测他们是否会对特定治疗产生反应。篮子和伞式试验的数量越来越多，但人们对它们仍然知之甚少。本文回顾了篮式试验和伞式试验的共同特征、关键试验和美国食品和药物管理局最近批准的精准肿瘤学，以及临床读者在批判性评估篮式试验和伞式试验的未来出版物时以及研究人员设计这些临床试验时的重要考虑因素. s 可以帮助预测他们是否会对特定治疗做出反应的风险因素。篮子和伞式试验的数量越来越多，但人们对它们仍然知之甚少。本文回顾了篮式试验和伞式试验的共同特征、关键试验和美国食品和药物管理局最近批准的精准肿瘤学，以及临床读者在批判性评估篮式试验和伞式试验的未来出版物时以及研究人员设计这些临床试验时的重要考虑因素. s 可以帮助预测他们是否会对特定治疗做出反应的风险因素。篮子和伞式试验的数量越来越多，但人们对它们仍然知之甚少。本文回顾了篮式试验和伞式试验的共同特征、关键试验和美国食品和药物管理局最近批准的精准肿瘤学，以及临床读者在批判性评估篮式试验和伞式试验的未来出版物时以及研究人员设计这些临床试验时的重要考虑因素.