Use of Historical Control Data in Carcinogenicity Studies in Rodents
Use of Historical Control Data in Carcinogenicity Studies in Rodents
复制标题
历史对照数据在啮齿类动物致癌性研究中的应用
DOI：
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发表时间：
1984
期刊：
影响因子：
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通讯作者：
G. Boorman
中科院分区：
文献类型：
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作者：
J. Haseman;J. Huff;G. Boorman
本文考虑使用历史对照数据评价啮齿动物致癌性研究的肿瘤发生率。尽管用于解释目的的最合适的对照组始终是同期对照，但在某些情况下，使用历史对照信息可以帮助研究者对肿瘤发生率数据进行总体评价。一个例子是罕见的肿瘤;另一个例子是相对于同期对照显示出轻微显著结果的肿瘤。然而，在历史对照数据可以用于正式的测试框架之前，必须首先考虑一些重要的问题。每项研究的命名惯例和诊断标准应相同，以确保在历史对照数据库中明确识别所有相关肿瘤。应制定标准，以帮助确定是否应将特定研究纳入数据库。这将确保一组同质的研究，作为统计比较的基础。由于肿瘤发生率的研究间变异性可能超过仅偶然的预期，因此应识别和控制这些变异性来源。最后，应采用统计程序，调整额外的二项变异。本文还总结了国家毒理学计划（NTP）历史对照数据库中未给药Fischer 344大鼠和B6 C3 F1小鼠的肿瘤发生率数据。数据库中的所有研究均持续2年，报告了发生频率为0.5%或以上的所有肿瘤。
This paper considers the use of historical control data in the evaluation of tumor incidences from carcinogenicity studies in rodents. Although the most appropriate control group for interpretative purposes is always the concurrent control, there are instances in which the use of historical control information can aid an investigator in the overall evaluation of tumor incidence data. One example is rare tumors; another is a tumor that shows a marginally significant result relative to concurrent controls. However, before historical control data can be used in a formal testing framework, a number of important issues must first be considered. The nomenclature conventions and diagnostic criteria for each study should be identical to insure unambiguous identification of all relevant tumors in the historical control database. Criteria should be established that will aid in determining whether a particular study should be included in the database. This will assure a homogeneous set of studies upon which to base statistical comparisons. Since study-to-study variability in tumor rates may exceed what would be expected by chance alone, these sources of variability should be identified and controlled. Finally, statistical procedures should be employed that adjust for extra-binomial variability. This paper also summarizes tumor incidence data from untreated Fischer 344 rats and B6C3F1 mice in the National Toxicology Program (NTP) historical control database. All studies in the database are of two years duration, and all neoplasms occurring with a frequency of 0.5% or more are reported.