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.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-252934
Responsible library:
WPRO
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.
Full text:
Available
Database:
WPRIM (Western Pacific)
Main subject:
Product Surveillance, Postmarketing
/
Reference Standards
/
Drugs, Chinese Herbal
/
Randomized Controlled Trials as Topic
/
Public Health
/
Cohort Studies
/
Sample Size
/
Therapeutic Uses
/
Drug Therapy
/
Drug-Related Side Effects and Adverse Reactions
Type of study:
Controlled clinical trial
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Etiology study
/
Incidence study
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Observational study
/
Risk factors
Aspects:
Social determinants of health
Limits:
Humans
Language:
Chinese
Journal:
China Journal of Chinese Materia Medica
Year:
2011
Document type:
Article