EBTC is conducting a systematic review to determine how well the Zebrafish Embryotoxicity Test (ZET) can predict developmental malformations in conventional guideline studies using rats and rabbits.
The primary aim of the project is to explore and potentially demonstrate the feasibility of applying systematic review as an approach to evaluating the predictivity of a toxicological test method.
The work group is focusing on identifying methodological challenges and developing appropriate solutions that comply with the fundamental principles of systematic review.The actual performance of the ZET compared to mammalian developmental toxicity studies is of secondary importance, acknowledging that ultimately human developmental toxicity has to be predicted.
This expansion of systematic review applications will be a valuable addition to the toolbox of evidence-based toxicology. Following discussions of the adapted and newly developed methodological approaches with relevant stakeholders, we aim for wide acceptance, which will spur further applications. Once the methodology is established, it can provide new means to the assessment of toxicological test methods, e.g. potentially completing or replacing so-called ‘retrospective validation’.
To achieve these goals we have registered the protocol of this systematic review inviting public comments. EBTC is collecting the lessons learned during this exercise and sharing them with the toxicological community. Ultimately, we will publish the results, always maintaining focus on the methodological aspects.
The project is being led by Sebastian Hoffmann. Project team members are scientists from academia, NGO and industry