The EC Joint Research Center (JRC) Directorate published on 22 November an article highlighting that JRC scientists are part of the international In Silico Toxicology (IST) Protocol initiative developing principles and protocols for the consistent use of computational models in chemical safety assessment to promote greater acceptance in regulatory applications.
The IST Protocol initiative focuses on how results from computational methods should be generated, interpreted, assessed and documented with a view to increasing confidence in their use. Work is in progress to apply the framework to specific toxicological parameters, such as genotoxicity, skin sensitization and systemic toxicity in acute and repeated doses.
It is interesting to note that the by presenting the IST protocol initiative, the JRC states that ‘’the regulatory acceptance of in silico approaches is still limited and one reason for this is the absence of harmonised protocols on how to properly apply methods and interpret results”. It appears that the Commission has begun to consider the problems resulting from the absence of a regulatory framework for in silico medicine. More importantly, by being part of this initiative, the Commission’ scientists are promoting the confidence and regulatory application of in silico methods.
The first publication of the consortium, published earlier this year, describes the general framework of the IST Protocols and how they could guide the international of computational predictions with experimental data to support the assessment of a chemical for adverse health effects, for instance in the context of drug development.
The IST Protocols include consideration of the reliability and relevance assessment of computational methods using a novel scoring scheme and the conduct and documentation of expert review using practical checklists. The IST expects that the use of the framework and associated protocols will increase the acceptance and uptake of in silico methodologies.