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Achieving Regulatory Alignment for Anti-Infective Clinical Trials.
ACS Infectious Diseases ( IF 5.3 ) Pub Date : 2020-06-12 , DOI: 10.1021/acsinfecdis.0c00270
Sumathi Nambiar 1 , Marco Cavaleri 2 , Junko Sato 3
Affiliation  

The growing concern of antimicrobial resistance coupled with the dearth of new antibacterial agents in development is a major public health threat. Multiple stakeholder efforts are underway to address the various challenges facing this field; while some progress has been made, antibacterial drug development continues to be a challenging area. The economic issues encountered in this space are probably today the most cogent; however, there are many other aspects that continue to pose challenges to enterprises engaging in this area, from the difficulties in discovering and advancing new classes of products to scientific issues with clinical trial design and feasibility in conducting these trials.

中文翻译:

实现抗感染临床试验的法规调整。

对抗菌素耐药性的日益关注以及在开发中缺乏新型抗菌剂是对公共健康的重大威胁。为了解决这一领域面临的各种挑战,利益相关者正在进行多种努力;尽管已经取得了一些进展,但是抗菌药物的开发仍然是一个充满挑战的领域。今天,在这个领域遇到的经济问题可能是最有说服力的。但是,从发现和推进新类别产品的困难到具有临床试验设计和进行这些试验的可行性的科学问题,还有许多其他方面继续对从事该领域的企业构成挑战。
更新日期:2020-06-12
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