How to ascertain drug safety in the context of benefit. Controversies and concerns.
J Rheumatol
; 36(9): 2114-21, 2009 Sep.
Article
em En
| MEDLINE
| ID: mdl-19738223
ABSTRACT
There is great concern about clearly defining benefit and risk in the context of both drug development and clinical practice. In view of this pressure, the OMERACT Executive identified the need to bring together clinical trialists, pharmacoepidemiologists, clinicians, clinical epidemiologists, statistical experts, and regulatory representatives to discuss different approaches to define risk and perhaps improved ways to express it. Each attendee spoke on a given topic and the group was charged to consider the issue of risk in the context of formally posed questions. This article provides a summary of the presentations and outlines the discussions that followed.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doenças Reumáticas
/
Antirreumáticos
/
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article