National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/33702

NTP Non-Cancer Evaluation Criteria

The National Toxicology Program (NTP) is working to bring the same rigorous standards it uses for classifying the outcomes of its cancer studies to its non-cancer studies.

NTP set out to develop new criteria to classify the outcomes from its non-cancer studies, including reproductivedevelopmental and immunotoxicity studies. These new criteria build off the classification system established in 1983 by NTP to evaluate its cancer studies.

NTP will use five categories or "levels of evidence" to describe its non-cancer study findings: clear evidence, some evidence, equivocal evidence, no evidence and inadequate study.

color bar graph of the five categories or levels of evidence

Timeline for the Development of Non-Cancer Evaluation Criteria

  • NTP set out to develop new criteria to classify the outcomes from its non-cancer studies, including reproductive, developmental and immunotoxicity studies. These new criteria build off the classification system established in 1983 by NTP to evaluate its cancer studies.
  • In June 2008, NTP established two working groups of the NTP Board of Scientific Counselors to provide input and help refine draft criteria developed by NTP for evaluating its reproductive, developmental and immunotoxicity studies.
  • In November 2008, the NTP Board of Scientific Counselors voted to accept and provide additional comments on the working group reports.
  • In December 2008, the NTP Executive Committee accepted the working group reports and provided additional comments on the criteria.
  • In February 2009, NTP finalized the levels of evidence statements for the three sets of criteria incorporating recommendations from the Board and the Executive Committee.
  • In March 2009, NTP presented the evaluation criteria to attendees at the Society for Toxicology 48th Annual Meeting and ToxExpoâ„¢ in Baltimore, Maryland.
  • NTP expects to begin applying the immunotoxicology criteria to studies for peer review by the end of 2015. The first reproductive and developmental studies featuring the new criteria could appear as early as 2015.

For more information, contact:

Paul M. Foster, Ph.D.
Discipline Leader for Reproduction and Development
Chief, Toxicology Branch
National Toxicology Program, NIH/NIEHS
P.O. Box 12233 MD K2-12, Research Triangle Park, NC 27709
Phone: 919-541-2513
Email: foster2@niehs.nih.gov

Dori Germolec, Ph.D.
Discipline Leader for Immunology
Toxicology Branch
National Toxicology Program, NIH/NIEHS
P.O. Box 12233 MD K2-12, Research Triangle Park, NC 27709
Phone: 919-541-3230
Email: germolec@niehs.nih.gov

NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.