ReviewAnnals of the New York Academy of Sciences2014
The evolution of the regulatory framework for antibacterial agents.
Review in Annals of the New York Academy of Sciences, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE's STAT-Net.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Article
- Mining Actinomycetes for Novel Antibiotics in the Omics Era: Are We Ready to Exploit This New Paradigm?Antibiotics (Basel, Switzerland) · 2018Review
- The Threat and Response to Infectious Diseases (Revised).Microbial ecology · 2018Review
- Avibactam Pharmacokinetic/Pharmacodynamic Targets.Antimicrobial agents and chemotherapy · 2018Review
- Antibiotics-From There to Where?: How the antibiotic miracle is threatened by resistance and a broken market and what we can do about it.Pathogens & immunity · 2018Review
- Narrow-Spectrum Antibacterial Agents.MedChemComm · 2018Article
- An assessment of the future impact of alternative technologies on antibiotics markets.Journal of pharmaceutical policy and practice · 2016Article
- Microspectrometric insights on the uptake of antibiotics at the single bacterial cell level.Scientific reports · 2015Article
- ESKAPEing the labyrinth of antibacterial discovery.Nature reviews. Drug discovery · 2015Review
- Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.Antimicrobial agents and chemotherapy · 2015Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The rising tide of antibacterial resistance and the lack of a diverse, vibrant pipeline of novel antibacterial agents is a global crisis that impairs our ability to treat life-threatening infections. The recent introduction of a tiered approach to the regulatory framework in this area offers one path to resolving some of the challenges. By drawing heavily on the predictive power of the related sciences of pharmacokinetics and pharmacodynamics, smaller, focused clinical trial programs have become possible for agents that might not otherwise have been possible to progress. There are limitations to these pathways, and they are not easy to implement, but making reliable noninferiority-based approaches available is critical to reinvigorating the global antibiotic pipeline. With the recognition of these ideas by key regulatory authorities in recent guidance, the next challenges in this area will focus on interpretive breakpoints, the extent of data in the prescribing information, ensuring that multiple agents can be progressed, and the challenge of the antibiotic business model.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.