Tian Feng, Fu Yingkun, Xie Yanming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Apr;36(8):1097-102.
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.
样本量是决定临床试验结果的重要因素之一，样本量估计方法的选择与临床试验的具体设计相关。在对上市后中药进行临床安全性再评价时，我们常设计队列研究、病例对照研究、巢式病例对照研究或医院集中监测，这些都需要大样本量。在评估广泛应用于大量人群的上市后中药的有效性时，实用随机对照试验（PRCT）比解释性随机对照试验（ERCT）更合适。ERCT对于上市后中药新适应症的验证性研究是必要的。根据具体目的、设计类型和评价指标，我们选择合适的样本量估计方法，并确定相应参数。我们必须根据具体的临床评价设计来估计和确定合适的样本量，同时综合考虑检验效能、研究成本和实际可操作性。
