Designing development programs for non-traditional antibacterial agents
Open Access
- 31 July 2019
- journal article
- research article
- Published by Springer Science and Business Media LLC in Nature Communications
- Vol. 10 (1), 1-10
- https://doi.org/10.1038/s41467-019-11303-9
Abstract
In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits that would benefit from extension of current paradigms. Discussion of such potential paradigms should be undertaken by the development community.Keywords
This publication has 54 references indexed in Scilit:
- A comprehensive regulatory framework to address the unmet need for new antibacterial treatmentsThe Lancet Infectious Diseases, 2013
- Biomarkers and surrogate endpoints in clinical trialsStatistics in Medicine, 2012
- Pharmacokinetic‐Pharmacodynamic Considerations in the Design of Hospital‐Acquired or Ventilator‐Associated Bacterial Pneumonia Studies: Look before You Leap!Clinical Infectious Diseases, 2010
- Limits to research risksJournal of Medical Ethics, 2009
- Use of Pharmacokinetics and Pharmacodynamics in a Failure Analysis of Community‐Acquired Pneumonia: Implications for Future Clinical Trial Study DesignClinical Infectious Diseases, 2008
- Non-inferiority trials are unethical because they disregard patients' interestsThe Lancet, 2007
- Antimicrobial Resistance: Pharmacokinetics‐Pharmacodynamics of Antimicrobial Therapy: It’s Not Just for Mice AnymoreClinical Infectious Diseases, 2007
- What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical ResearchThe Journal of Infectious Diseases, 2004
- Biomarkers and surrogate endpoints: Preferred definitions and conceptual frameworkClinical Pharmacology & Therapeutics, 2001
- State‐of‐the‐Art Clinical Article: Pharmacokinetic/Pharmacodynamic Parameters: Rationale for Antibacterial Dosing of Mice and MenClinical Infectious Diseases, 1998