Stallard N, Whitehead A
Medical and Pharmaceutical Statistics Research Unit, University of Reading, Reading, RG6 6FN, United Kingdom.
Regul Toxicol Pharmacol. 1996 Jun;23(3):244-8. doi: 10.1006/rtph.1996.0049.
Long-term animal carcinogenicity studies are an important part of the risk analysis process assessing the carcinogenic potential of products to humans. Results from the statistical analysis of the data from such studies are generally presented as a series of hypothesis tests indicating whether there was a significant rise in the number of tumors at given sites. The conclusion from such an analysis depends on the size of the experiment. In particular, the number of false-negative results can be high when tumors are rare. In this paper, a test for equivalence fixing the proportion of false negatives is proposed. The effect on the required sample size is also discussed.
长期动物致癌性研究是评估产品对人类致癌潜力的风险分析过程的重要组成部分。对此类研究数据进行统计分析的结果通常以一系列假设检验的形式呈现，表明在特定部位肿瘤数量是否有显著增加。此类分析的结论取决于实验规模。特别是，当肿瘤罕见时，假阴性结果的数量可能会很高。本文提出了一种固定假阴性比例的等效性检验方法。还讨论了其对所需样本量的影响。
