肿瘤学II期试验的统计设计、概况和成功率的九年变化
Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.
作者信息
Ivanova Anastasia, Paul Barry, Marchenko Olga, Song Guochen, Patel Neerali, Moschos Stergios J
机构信息
a Department of Biostatistics , The University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.
b Department of Medicine , The University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.
出版信息
J Biopharm Stat. 2016;26(1):141-9. doi: 10.1080/10543406.2015.1092030.
Abstract
We investigated nine-year trends in statistical design and other features of Phase II oncology clinical trials published in 2005, 2010, and 2014 in five leading oncology journals: Cancer, Clinical Cancer Research, Journal of Clinical Oncology, Annals of Oncology, and Lancet Oncology. The features analyzed included cancer type, multicenter vs. single-institution, statistical design, primary endpoint, number of treatment arms, number of patients per treatment arm, whether or not statistical methods were well described, whether the drug was found effective based on rigorous statistical testing of the null hypothesis, and whether the drug was recommended for future studies.
摘要
我们调查了2005年、2010年和2014年发表在五本领先肿瘤学期刊（《癌症》《临床癌症研究》《临床肿瘤学杂志》《肿瘤学年鉴》和《柳叶刀肿瘤学》）上的II期肿瘤学临床试验的统计设计及其他特征的九年间变化趋势。分析的特征包括癌症类型、多中心与单机构、统计设计、主要终点、治疗组数量、每个治疗组的患者数量、统计方法是否得到充分描述、药物是否基于对原假设的严格统计检验被判定有效，以及该药物是否被推荐用于未来研究。
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