Best Practices in Social and Behavioral Research: A multisite pilot evaluation of the good clinical practice online training course.

INTRODUCTION: The Best Practices in Social and Behavioral Research Course was developed to provide instruction on good clinical practice for social and behavioral trials. This study evaluated the new course. METHODS: Participants across 4 universities took the course (n=294) and were sent surveys following course completion and 2 months later. Outcomes included relevance, how engaging the course was, and working differently because of the course. Open-ended questions were posed to understand how work was impacted. RESULTS: Participants rated the course as relevant and engaging (6.4 and 5.8/7 points) and reported working differently (4.7/7 points). Participants with less experience in social and behavioral trials were most likely to report working differently 2 months later. DISCUSSION: The course was perceived as relevant and engaging. Participants described actions taken to improve rigor in implementing trials. Future studies with a larger sample and additional participating sites are recommended.

Implications of the lack of accuracy of the lifetime rodent bioassay for predicting human carcinogenicity.

The NTP lifetime rodent bioassay (LRB) is the "gold standard" for predicting human carcinogenicity. Unfortunately, little attempt has been made to validate it against human carcinogenicity. Here we show that the extremely limited data available do not support either of the two common interpretations of LRB results. If a risk-avoidance interpretation is used where any positive result in a sex/species combination is considered positive, 9 of the 10 known human carcinogens tested are positive, but an implausible 22% of all chemicals are positive. If a less risk averse interpretation is used where only chemicals positive in both rats and mice are considered positive, only 3 of the 6 known human carcinogens tested are positive. In either interpretation, some known human carcinogens are not positive in the LRB, potentially allowing widespread human exposure to misidentified chemicals. Improving the predictive accuracy of the LRB and other tests for human carcinogenicity requires that test results be validated against the known human carcinogenicity of chemicals. This will require redirecting available resources from screening chemicals to validating carcinogenicity tests as well as a substantial investment in epidemiology to identify more known human carcinogens and presumed human non-carcinogens.