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新型抗菌药物临床开发面临的挑战与解决方案：制药行业专业人士的调查结果

Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.

作者信息

Bettiol Esther, Wetherington Jeffrey D, Schmitt Nicola, Harbarth Stephan

机构信息

Infection Control Program and Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland

Quantitative Sciences, GlaxoSmithKline, Philadelphia, Pennsylvania, USA.

出版信息

Antimicrob Agents Chemother. 2015 Jul;59(7):3695-9. doi: 10.1128/AAC.00638-15. Epub 2015 Apr 27.

DOI:10.1128/AAC.00638-15
PMID:25918147
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4468719/
Abstract

As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial and regulatory. For multidrug-resistant organisms, there are needs for rapid diagnostic tests, new regulatory guidance, and adaptation of endpoints/trial designs. Regulators and public/private initiatives are addressing these challenges to help ensure that proposed solutions have the support of all involved stakeholders.

摘要

由于正在研发的抗菌药物数量仍然很少，我们对制药行业专业人士进行了匿名调查，了解这些药物临床开发面临的挑战及解决方案。报告的挑战主要是财务和监管方面的。对于耐多药微生物，需要快速诊断测试、新的监管指南以及调整终点指标/试验设计。监管机构以及公共/私人倡议正在应对这些挑战，以帮助确保所提出的解决方案得到所有相关利益攸关方的支持。

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本文引用的文献

1
Antibiotics: the changing regulatory and pharmaceutical industry paradigm.抗生素：不断变化的监管与制药行业范式
J Antimicrob Chemother. 2015 May;70(5):1281-4. doi: 10.1093/jac/dku572. Epub 2015 Jan 28.
2
Novel approaches are needed to develop tomorrow's antibacterial therapies.需要新的方法来开发未来的抗菌疗法。
Am J Respir Crit Care Med. 2015 Jan 15;191(2):135-40. doi: 10.1164/rccm.201410-1894OE.
3
Antibacterial drug development: challenges, recent developments, and future considerations.抗菌药物研发：挑战、最新进展及未来思考。
Clin Pharmacol Ther. 2014 Aug;96(2):147-9. doi: 10.1038/clpt.2014.116.
4
An analysis of FDA-approved drugs for infectious disease: antibacterial agents.FDA 批准用于传染病的药物分析：抗菌药物。
Drug Discov Today. 2014 Sep;19(9):1283-7. doi: 10.1016/j.drudis.2014.07.005. Epub 2014 Jul 17.
5
First QIDP drug approved, but designation may fail urgent needs.首个合格传染病产品（QIDP）药物获批，但该认定可能无法满足迫切需求。
Nat Med. 2014 Jul;20(7):690-1. doi: 10.1038/nm0714-690.
6
The challenge of antimicrobial resistance: new regulatory tools to support product development.抗菌药物耐药性的挑战：支持产品开发的新监管工具。
Clin Pharmacol Ther. 2014 Aug;96(2):166-8. doi: 10.1038/clpt.2014.107. Epub 2014 May 13.
7
The evolution of the regulatory framework for antibacterial agents.抗菌药物监管框架的演变
Ann N Y Acad Sci. 2014 Sep;1323(1):11-21. doi: 10.1111/nyas.12441. Epub 2014 May 2.
8
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10
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