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Title

Challenges and solutions for clinical development of new antibacterial agents: Results of a survey among pharmaceutical industry professionals
Authors
Bettiol, Esther Odile
Wetherington, Jeffrey D
Schmitt, Nicolas
Harbarth, Stéphan Juergen
Published in Antimicrobial Agents and Chemotherapy. 2015, vol. 59, no. 7, p. 3695-99
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 multi-drug 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 ensuring that proposed solutions have the support of all involved stakeholders.
Keywords Clinical trials, clinical development, antibacterial agent, multi-drug resistant organisms, regulatory, clinical trial design, pathogen-based trial, indication-based trial, pharmaceutical companies
Identifiers
PMID: 25918147
Full text
Article (Published version) (852 Kb) - document accessible for UNIGE members only Limited access to UNIGE
Structures
Faculté de médecine / Section de médecine clinique / Département de médecine interne des spécialités
Research group Groupe Harbarth Stephan (Staphylocoques dorés résistants à la méthicilline) (866)
Project IMI grant agreement n° 115523 [Combatting Bacterial Resistance in Europe -- COMBACTE]
Citation
(ISO format) 		BETTIOL, Esther Odile et al. Challenges and solutions for clinical development of new antibacterial agents: Results of a survey among pharmaceutical industry professionals. In: Antimicrobial Agents and Chemotherapy, 2015, vol. 59, n° 7, p. 3695-99. https://archive-ouverte.unige.ch/unige:73786

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Deposited on : 2015-07-01

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