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2018-2019 年美国和欧洲新型药物的治疗价值评估。

Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019.

机构信息

Institute of Law, University of Zurich, Zurich, Switzerland.

Program on Regulation, Therapeutics, and Law, Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA Netw Open. 2022 Apr 1;5(4):e226479. doi: 10.1001/jamanetworkopen.2022.6479.

DOI:10.1001/jamanetworkopen.2022.6479
PMID:35385091
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8987900/
Abstract

This economic evaluation study assesses the clinical benefit of novel drugs approved in 2018 and 2019 and examines whether drugs approved with special regulatory designations appear to provide meaningful therapeutic value.

摘要

本经济评价研究评估了 2018 年和 2019 年批准的新药的临床获益,并考察了具有特殊监管地位批准的药物是否具有有意义的治疗价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c3/8987900/0c70927902d9/jamanetwopen-e226479-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c3/8987900/0c70927902d9/jamanetwopen-e226479-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c3/8987900/0c70927902d9/jamanetwopen-e226479-g001.jpg

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Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.FDA 和 EMA 加速审批计划与新药的治疗价值之间的关联:回顾性队列研究。
BMJ. 2020 Oct 7;371:m3434. doi: 10.1136/bmj.m3434.
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Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs.
中国急需药品的加速审批
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Defining 'therapeutic value' of medicines: a scoping review.定义药品的“治疗价值”:范围综述。
BMJ Open. 2023 Dec 18;13(12):e078134. doi: 10.1136/bmjopen-2023-078134.
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