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

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

Esther Bettiol  1 , Jeffrey D Wetherington  2 , Nicola Schmitt  3 , Stephan Harbarth  4 ; COMBACTE Consortium
Affiliations

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

Esther Bettiol et al. Antimicrob Agents Chemother. 2015 Jul.

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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Figures

FIG 1
FIG 1
Response to the question “what are the three most frequent reasons for stopping the clinical development of new antibacterial agents?” n = 58.
FIG 2
FIG 2
Opinions on the positive impact that changes in regulatory pathways and guidance might have on the successful development of new antibacterial agents. MDRO, multidrug-resistant organism; LPAD, limited-population antibacterial drug; M&S, modeling and simulation.
FIG 3
FIG 3
Opinions on study design for registration trials assessing safety and efficacy of new antibacterial agents for infections caused by MDRO.
See this image and copyright information in PMC

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