Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 27481955.
- Also identified by DOI 10.1093/cid/ciw244 and PMC identifier 4967592.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
The economics of antibiotics can be improved by infectious diseases-specific clinical trial networks. While developers would still need to implement an independent phase 1 program as well as studies focused on highly resistant pathogens, standardized procedures in a network focused on usual drug resistance phenotype isolates would permit sharing of controls and would predictably generate high-quality pivotal data for product registration while creating cost and time savings in the range of 30%-40%. This would reduce economic barriers to antibiotic development and contribute to public health.
Medical subject headings
- Anti-Bacterial Agents
- Clinical Trials as Topic
- Communicable Diseases
- Drug Discovery
- Patient Outcome Assessment