• Antimicrob. Agents Chemother. · Jul 2015

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

    • Esther Bettiol, Jeffrey D Wetherington, Nicola Schmitt, Stephan Harbarth, and COMBACTE Consortium.
    • Infection Control Program and Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland esther.bettiol@hcuge.ch.
    • Antimicrob. Agents Chemother. 2015 Jul 1; 59 (7): 3695-9.

    AbstractAs 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.Copyright © 2015, American Society for Microbiology. All Rights Reserved.

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