Category Research project
  • Toxikologie

Use and Reporting of Historical Control Data

Project status
Completed
Project start
Jan 2025
Project end
Apr 2025
Acronym
CaseHCD2
Department
Sicherheit von Pestiziden

Description and Objective

This is the continuation / follow-up of the previous project "Use and Reporting of Historical Control Data". The questions raised there are to be addressed and gaps filled. The focus is on ‘count data’ and ‘continuous data’ with information on individual animals from 2-generation reproduction toxicity studies. Background:The statistical evaluation of toxicological tests regularly results in so-called statistically significant findings in the treated group when compared with the control group due to the significance level applied and the parallel testing of multiple parameters. Historical control data (HCD) play a prominent role in categorising the biological significance of such statistically significant findings. In addition, the comparison of the included control with the historical control data provides an important statement about the representativeness of the respective experiment. However, the availability of HCD is limited and its use is handled very differently. This project makes an important contribution to improving this situation. The feasibility of a proposed method for collecting HCDs and assessing their quality will be tested in 3 case studies. The eASB study archive available in Division Pesticides Safety, which is unique in its type and scope and is not available elsewhere, will be used for this purpose. Approaches for further refinement of the procedure are being developed and published together with EFSAshort forEuropean Food Safety Authority. Translated with DeepL.com (free version)

Result

A total of six case studies were carried out to test the new, step-by-step methodology for the collection and evaluation of historical control data for toxicological studies. Case studies 5 and 6 formed the subject of Project Part 2 in 2025. These case studies served to finalise the EFSAshort forEuropean Food Safety Authority Scientific Opinion ‘Use and reporting of historical control data for regulatory studies’, which was published in the EFSAshort forEuropean Food Safety Authority Journal. (2025), 23:e9576 (https://doi.org/10.2903/j.efsa.2025.9576). Excerpts from the case studies are published in Annexes A–C of the EFSAshort forEuropean Food Safety Authority Opinion and were taken into account during the revision of the reporting templates in Annexes E–G. The application of the new methodology will become mandatory in the EU pesticide authorisation procedure from 2028.
Type of project

Third-party funded project

Areas of research

Gesundheit von Mensch, Tier und Umwelt (One Health)

Organisational units and partners

Lead unit: Toxikologie der Wirkstoffe und ihrer Metabolite (63)
Contact persons: Dr. Carsten Kneuer, Dr. Susanne Rudzok

Funding body and grant number

Europäische Behörde für Lebensmittelsicherheit
PO/EFSAshort forEuropean Food Safety Authority/PREV/2024/05

Publications

https://doi.org/10.2903/j.efsa.2025.9576

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