Format

Send to

Choose Destination

See 1 citation found by title matching your search:

Nat Commun. 2019 Jul 31;10(1):3416. doi: 10.1038/s41467-019-11303-9.

Designing development programs for non-traditional antibacterial agents.

Author information

1
F2G Limited, Eccles, Cheshire, M30 0LX, UK. john.rex@f2g.com.
2
McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, 77030, USA. john.rex@f2g.com.
3
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, 19104, USA.
4
Harvard Law School, Cambridge, MA, 02138, USA.
5
Petrie-Flom Center, Cambridge, MA, 02138, USA.
6
Harvard Medical School, Boston, MA, 02115, USA.
7
Boston University School of Law, CARB-X, Boston, MA, 02215, USA.

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.

PMID:
31366924
PMCID:
PMC6668399
DOI:
10.1038/s41467-019-11303-9
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Nature Publishing Group Icon for PubMed Central
Loading ...
Support Center