EBTC believes that adopting principles of transparency, objectivity and consistency in the spirit of the Cochrane principles in medicine, will allow regulators, industry and other stakeholders to make more informed decisions about the effects of chemicals on human health and the environment.
An especially important goal is to determine the accuracy and validity of current methods for testing chemical safety methods, and assess new tests which are coming into use. This allows alignment between scientific advances, the methods used by scientists in research and industry laboratories and the data requirements of regulatory agencies across worldwide.
It is particularly timely as toxicology moves to embrace pathway-based approaches, as exemplified by the National Academy of Sciences’ 2007 report Toxicity Testing in the 21st Century.
These include new methods that assess potential health effects at multiple levels of biological organization (e.g. via organ-on-a-chip), delivering complex data that needs to be integrated with traditional (e.g. animal-based) toxicological experiments.
With the availability of data generated by the US EPA's multi-year ToxCastTM (ToxCast) project, and the Toxicology in the 21st Century (Tox21) federal collaborative program between US EPA, FDA, NIH, NTP at NIEHS, there is now a real opportunity to address if and how this type of mechanistic data can be used in the risk assessment process of chemicals.
EBTC has established a working group that is in the process of studying how the mechanistic data from ToxCast and Tox21 can be used in human safety assessment.
The group is currently completing a systematic review of animal and human data on a number of approved drugs with and without drug-induced liver injury (DILI), as stated in the US FDA Liver Toxicity Knowledge Base.
The observed adverse effect (AE) profile in experimental animals together with the AE profile as observed in patients in randomized controlled trials and post-marketing surveillance data (Real World Evidence) will be compared with the pathways signatures based on ToxCast and Tox21 data set.