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本文引用的文献

1
Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.癌症药物加速审批的临床获益和监管结果。
JAMA. 2024 May 7;331(17):1471-1479. doi: 10.1001/jama.2024.2396.
2
A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials.一项关于在干预性试验中替代终点使用的定义与解释的框架。
EClinicalMedicine. 2023 Oct 17;65:102283. doi: 10.1016/j.eclinm.2023.102283. eCollection 2023 Nov.
3
Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022.2015年至2022年期间支持中国新型癌症药物获得有条件批准的批准前临床试验证据。
EClinicalMedicine. 2023 Aug 24;63:102177. doi: 10.1016/j.eclinm.2023.102177. eCollection 2023 Sep.
4
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study.加速批准癌症药物阴性确证性试验的监管和临床后果：回顾性观察研究。
BMJ. 2021 Sep 8;374:n1959. doi: 10.1136/bmj.n1959.
5
FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019.美国食品药品监督管理局对用于癌症药物批准的替代终点的认可：1992 - 2019年
JAMA Intern Med. 2020 Jun 1;180(6):912-914. doi: 10.1001/jamainternmed.2020.1097.
6
Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.美国食品药品监督管理局批准加速批准的药物的批准前和批准后研究特征。
JAMA. 2017 Aug 15;318(7):626-636. doi: 10.1001/jama.2017.9415.

Confirmatory Trials for Drugs Granted Conditional Approval by the Chinese National Medical Products Administration.

作者信息

Tian Yun, Liu Xiaoyong, Liu Xingyu, Zhang Jinwei, Hu Shuchen, Yang Caijun, Fang Yu

机构信息

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, China.

Center for Drug Safety and Policy Research, Xi'an Jiaotong University, Xi'an, China.

出版信息

JAMA Health Forum. 2024 Dec 6;5(12):e244601. doi: 10.1001/jamahealthforum.2024.4601.

DOI:10.1001/jamahealthforum.2024.4601
PMID:39729303
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11681369/
Abstract
摘要