Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.
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.
Infection Control Program and Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland esther.bettiol@hcuge.ch.
Esther
E
Bettiol
Quantitative Sciences, GlaxoSmithKline, Philadelphia, Pennsylvania, USA.
Jeffrey D
JD
Wetherington
Biometrics and Information Sciences, AstraZeneca, Macclesfield, United Kingdom.
Nicola
N
Schmitt
Infection Control Program and Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
Stephan
S
Harbarth
D000900:Anti-Bacterial Agents; D002985:Clinical Protocols; D055808:Drug Discovery / Q000191:economics* / Q000379:methods; D004345:Drug Industry; D024901:Drug Resistance, Multiple, Bacterial; D006801:Humans; D011795:Surveys and Questionnaires
D000900:Anti-Bacterial Agents