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

新型抗菌药物临床开发的挑战与解决方案:一项针对制药行业专业人士的调查结果

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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.

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