Discussion on methods of sample size estimation in conducting clinical reevaluation of postmarketing Chinese medicine / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 1097-1102, 2011.
Artículo
en Chino
| WPRIM
| ID: wpr-252934
ABSTRACT
Sample size is one of important factors determining the results of a clinical trial, and the choice of sample size estimation methods is related to the specific design of clinical trials. On clinical safety reevaluation of postmarketing Chinese medicine, we often design cohort study, case-control study, nested case-control study or hospital centralized monitoring, which need large sample sizes. In evaluating the effectiveness of postmarketing Chinese medicine widely applied in the large population, pragmatic randomized controlled trial (PRCT) is more suitable than explanatory randomized controlled trial (ERCT). ERCT is necessary to conduct confirmatory study for new indications of postmarketing Chinese medicine. According to the specific purpose, design type and evaluation index, we choose the suitable sample size estimation method, and determine the corresponding parameters. We must estimate and determine the suitable sample size according to the specific clinical evaluation design, with comprehensive consideration of the test power, research cost and practical operability.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Vigilancia de Productos Comercializados
/
Estándares de Referencia
/
Medicamentos Herbarios Chinos
/
Ensayos Clínicos Controlados Aleatorios como Asunto
/
Salud Pública
/
Estudios de Cohortes
/
Tamaño de la Muestra
/
Usos Terapéuticos
/
Quimioterapia
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio de etiología
/
Estudio de incidencia
/
Estudio observacional
/
Factores de riesgo
Límite:
Humanos
Idioma:
Chino
Revista:
China Journal of Chinese Materia Medica
Año:
2011
Tipo del documento:
Artículo
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