Examining the Use of Real-World Evidence in the Regulatory Process.
Clin Pharmacol Ther
; 107(4): 843-852, 2020 04.
Article
em En
| MEDLINE
| ID: mdl-31562770
The 21st Century Cures Act passed by the United States Congress mandates the US Food and Drug Administration to develop guidance to evaluate the use of real-world evidence (RWE) to support the regulatory process. RWE has generated important medical discoveries, especially in areas where traditional clinical trials would be unethical or infeasible. However, RWE suffers from several issues that hinder its ability to provide proof of treatment efficacy at a level comparable to randomized controlled trials. In this review article, we summarized the advantages and limitations of RWE, identified the key opportunities for RWE, and pointed the way forward to maximize the potential of RWE for regulatory purposes.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Ensaios Clínicos como Assunto
/
Medicina Baseada em Evidências
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Clin Pharmacol Ther
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos
País de publicação:
Estados Unidos