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保持 III 期结核病临床试验的相关性：适应快速变化的格局。

Keeping phase III tuberculosis trials relevant: Adapting to a rapidly changing landscape.

机构信息

School of Medicine, UCSF Center for TB, University of California San Francisco, San Francisco, California, United States of America.

Harvard Medical School, Boston, Massachusetts, United States of America.

出版信息

PLoS Med. 2019 Mar 22;16(3):e1002767. doi: 10.1371/journal.pmed.1002767. eCollection 2019 Mar.

DOI:10.1371/journal.pmed.1002767
PMID:30901331
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6430373/
Abstract

In a Collection Review, Patrick Phillips and colleagues discuss developments in clinical trial design for the evaluation of TB therapeutics.

摘要

在一篇文献综述中，Patrick Phillips 及其同事讨论了评估结核病治疗药物的临床试验设计方面的进展。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9940/6430373/2b7b5832cf80/pmed.1002767.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9940/6430373/2b7b5832cf80/pmed.1002767.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9940/6430373/2b7b5832cf80/pmed.1002767.g001.jpg

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Improving treatment outcomes for MDR-TB - Novel host-directed therapies and personalised medicine of the future.提高耐多药结核病的治疗效果-未来的新型宿主导向治疗和个体化医学。
Int J Infect Dis. 2019 Mar;80S:S62-S67. doi: 10.1016/j.ijid.2019.01.039. Epub 2019 Jan 24.
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Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial.
A comparison of clinical development pathways to advance tuberculosis regimen development.
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BMC Infect Dis. 2022 Dec 9;22(1):920. doi: 10.1186/s12879-022-07846-w.
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Comparing timelines and evidence available to support new TB, HIV, and HCV drug approvals: The same, only different.比较支持新的结核病、艾滋病病毒和丙型肝炎病毒药物批准的时间线和现有证据：大同小异。
PLoS One. 2022 Jul 25;17(7):e0271102. doi: 10.1371/journal.pone.0271102. eCollection 2022.
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Rethinking intercurrent events in defining estimands for tuberculosis trials.重新思考结核药物临床试验中定义目标人群时的伴随事件。
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