PMID: 8972110Dec 1, 1996Paper

Evaluation of false positive and false negative outcomes in NTP long-term rodent carcinogenicity studies

Risk Analysis : an Official Publication of the Society for Risk Analysis
J Haseman, M R Elwell

Abstract

The decision-making process used by the National Toxicology Program (NTP) in its evaluation of long-term rodent carcinogenicity studies was investigated to determine whether or not this procedure resulted in an excessive number of false positive or false negative outcomes. All site-specific tumor incidences that were found to be significantly (p < 0.05) increased either by a trend test or by pairwise comparisons of each dosed group against the controls in 218 NTP 2-year studies with Fischer 344 rats and/or B6C3F1 mice were tabulated and compared to the number of statistically significant tumor increases expected to occur by chance. Our evaluation suggests that false positive rates are fairly low in NTP long-term studies. Assessing false negative rates is more difficult because of the limited sensitivity of the bioassay for detecting subtle carcinogenic effects. Moreover, reduced body weights frequently occur in dosed animals, and the positive correlation between the incidences of certain site-specific tumors and body weight may mask the detection of carcinogenic effects. Despite these difficulties, our analysis did identify one tumor showing evidence of false negative outcomes: interstitial cell tumors of the testis in male Fis...Continue Reading

References

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Citations

Jul 25, 2003·Regulatory Toxicology and Pharmacology : RTP·Fanny K Ennever, Lester B Lave
Dec 21, 2006·Toxicologic Pathology·Alan M JeffreyGary M Williams
Apr 5, 2003·Environmental Health Perspectives·John B PritchardJoseph K Haseman
Feb 9, 2005·Regulatory Toxicology and Pharmacology : RTP·David W Gaylor
Nov 30, 2013·Regulatory Toxicology and Pharmacology : RTP·Palma Ann MaroneA Wallace Hayes
Dec 19, 2002·Environmental Health Perspectives·Steve Wing, David Richardson
Dec 4, 2002·Environmental Health Perspectives·Frank M Johnson, James Huff
Jul 17, 1998·Risk Analysis : an Official Publication of the Society for Risk Analysis·K S CrumpY Wang
Feb 15, 2001·Environmental and Molecular Mutagenesis·R TennantR E Stoll

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