The objective of the conference was to assemble scientists from government, academia, and industry to discuss the new and emerging methods and approaches for assessing the carcinogenic potential of chemicals. Carcinogenicity studies are an important component of toxicological evaluation of drugs and chemicals. The rodent bioassay is the most commonly used test in such evaluations, but because of its time-and resource-intensive nature, it is not practical to conduct this test for all chemicals of interest. Additionally, the standard bioassay does not address the mechanisms of carcinogenic action, which are critical for accurately assessing the human risk from exposure to a drug or chemical.
In the last several years, there has been a substantial increase in our knowledge of and ability to study the mechanistic bases of carcinogenesis. Computer, molecular, cellular, and animal methods for predicting carcinogenic potential have been developed based on these advances. Mechanistic approaches for better understanding dose-response relationships and extrapolating rodent results to humans are also being increasingly used. The use of mechanistic data in the assessment of human carcinogenic risk from chemical exposure and the current status and application of the new approaches for regulatory decision making were also discussed at the conference. The papers in this issue reflect the findings and thoughts of the conference participants on these issues.