Evidence-Based Toxicology (Preprints and Peer-Reviews)

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Published September 4, 2023 | Version 1
Journal article Open

Protocol: Testing the performance of INVITES-IN, a tool for assessing the internal validity of in vitro studies

Authors/Creators

  • 1. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway
  • 2. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway
  • 3. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Lancaster Environment Centre, Lancaster University, Lancaster, UK
  • 4. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Department of Method Development and Analytics, Norwegian Institute of Public Health, Oslo, Norway
  • 5. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Department of Food Safety, Norwegian Institute of Public Health, Oslo, Norway
  • 6. Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
  • 7. Environment & Health Department, Italian National Institute of Health (ISS), Rome, Italy
  • 8. United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA
  • 9. Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA AND CAAT Europe, University of Konstanz, Konstanz, Germany
  • 10. Evidence-based toxicology collaboration (EBTC), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA AND seh consulting + services, Paderborn, Germany
  • 11. Department of Anesthesiology, Pain and Palliative Care, Radboud University Medical Centre, Nijmegen, Netherlands
  • 12. Laboratory of Toxicological Control of Pesticides, Scientific Directorate of Pesticides' Control and Phytopharmacy, Benaki Phytopathological Institute, Kifissia, Greece
  • 13. European Commission, Joint Research Centre (JRC), Ispra, Italy
  • 14. Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco (UCSF), USA
  • 15. 3Rs Management and Consulting ApS, Lyngby, Denmark
  • 16. Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA
  • 17. Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland AND Swiss Centre for Applied Human Toxicology (SCAHT), Switzerland
  • 18. Department of Pharmaceutical and Pharmacological Sciences, Vrije Universiteit Brussel; Belgium
  • 19. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Department of Chemical Toxicology, Norwegian Institute of Public Health, Oslo, Norway

Description

A tool for evaluation of internal validity of in vitro studies called INVITES-IN is currently under development. The tool is designed specifically for cell culture studies.

This protocol describes the testing of the performance of INVITES-IN. By performance, we mean the extent to which results of using INVITES-IN are the same for different users (consistency), the amount of time and cognitive effort it takes to apply INVITES-IN (assessor workload), the precision and potential for systematic error in results of applying INVITES-IN (accuracy), and how easy it is to use INVITES-IN (user experience).

The participants in the user testing will be representative for the expected end-users of INVITES-IN which are persons preparing literature reviews including in vitro studies (e.g. in the context of chemical hazard and risk assessments or drug development). All end-users are expected to have experience with in vitro methods.

Data collected from the performance testing will be used for further refinement and development of the release version of INVITES-IN.

Notes

Funding: The Swiss State Secretariat for Education, Research and Innovation (SERI) under contract no. 22.00230

Files

Declaration of Interest_Submitted 04092023.pdf

Files (2.4 MB)

Additional details

Funding

European Commission
PARC - Partnership for the Assessment of Risks from Chemicals 101057014