Efficient confidence limits for adaptive one-arm two-stage clinical trials with binary endpoints
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- 作者：Guogen Shan ; Hua Zhang ; Tao Jiang
- 关键词：Adaptive design ; Clopper ; Pearson approach ; Exact one ; sided interval ; Response rate ; Two ; stage design
- 刊名：BMC Medical Research Methodology
- 出版年：2017
- 出版时间：December 2017
- 年：2017
- 卷：17
- 期：1
- 全文大小：589KB
- 刊物主题：Theory of Medicine/Bioethics; Statistical Theory and Methods; Statistics for Life Sciences, Medicine, Health Sciences;
- 出版者：BioMed Central
- ISSN：1471-2288
- 卷排序：17
文摘
BackgroundRecently, several adaptive one-arm two-stage designs have been developed by fully using the information from previous stages to reduce the expected sample size in clinical trials with binary endpoints as primary outcome. It is important to compute exact confidence limits for these studies.