Data quality challenges in systemic lupus erythematosus trials: how can this be optimized?
Curr Rheumatol Rep
; 14(4): 324-33, 2012 Aug.
Article
en En
| MEDLINE
| ID: mdl-22580894
ABSTRACT
Major scientific advances in basic science, pharmacology, and translational medicine have allowed the discovery of new molecular targets whose manipulation by new chemical entities has led to treatments for inflammatory diseases, including rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. Development of new agents for systemic lupus erythematosus (SLE) has lagged, however, because the protean manifestations of SLE present challenges for measuring therapeutic effects in a consistent manner. Composite end points combining several Disease Activity Indices (DAIs) are being used in ongoing global studies, but the uniform application of these complex DAIs across large numbers of clinical sites has proven difficult. We describe herein approaches that are being utilized to facilitate collection, review, and analysis of the clinical measures utilizing independent central adjudication committees.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Ensayos Clínicos como Asunto
/
Lupus Eritematoso Sistémico
Límite:
Humans
Idioma:
En
Revista:
Curr Rheumatol Rep
Asunto de la revista:
REUMATOLOGIA
Año:
2012
Tipo del documento:
Article
País de afiliación:
Estados Unidos