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.
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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