Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
Clin Infect Dis
; 63 Suppl 2: S57-9, 2016 Aug 15.
Article
em En
| MEDLINE
| ID: mdl-27481955
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doenças Transmissíveis
/
Ensaios Clínicos como Assunto
/
Descoberta de Drogas
/
Avaliação de Resultados da Assistência ao Paciente
/
Antibacterianos
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article