Protocol for designing INVITES-IN, a tool for assessing the internal validity of in vitro studies
Creators
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Svendsen, Camilla1
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Whaley, Paul2
- Vist, Gunn E3
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Husøy, Trine4
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Beronius, Anna5
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Di Consiglio, Emma6
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Druwe, Ingrid7
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Hartung, Thomas8
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Hatzi, Vasiliki I9
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Hoffmann, Sebastian10
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Hooijmans, Carlijn R11
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Kass, Georges12
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Machera, Kyriaki9
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Robinson, Joshua F13
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Roggen, Erwin14
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Rooney, Andrew A15
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Roth, Nicolas16
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Spilioti, Eliana9
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Spyropoulou, Anastasia9
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Tcheremenskaia, Olga6
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Testai, Emanuela6
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Vinken, Mathieu17
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Mathisen, Gro Haarklou18
- 1. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway & Department of Chemical Toxicology, Norwegian Institute of Public Health, Oslo, Norway
- 2. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway & Lancaster Environment Centre, Lancaster University, Lancaster, UK
- 3. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway & Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway
- 4. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway & Department of Food Safety, Norwegian Institute of Public Health, Oslo, Norway
- 5. Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
- 6. Environment & Health Department, Italian National Institute of Health (ISS), Rome, Italy
- 7. United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA
- 8. Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA & CAAT Europe, University of Konstanz, Konstanz, Germany
- 9. Laboratory of Toxicological Control of Pesticides, Scientific Directorate of Pesticides' Control and Phytopharmacy, Benaki Phytopathological Institute, Kifissia, Greece
- 10. Evidence-Based Toxicology Collaboration (EBTC), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA & seh consulting + services, Paderborn, Germany
- 11. Department of Anesthesiology, Pain and Palliative Care, Radboud University Medical Centre, Nijmegen, Netherlands
- 12. European Food Safety Authority, Parma, Italy
- 13. Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco (UCSF), USA
- 14. 3Rs Management and Consulting ApS, Lyngby, Denmark
- 15. Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA
- 16. Department of Pharmaceutical Sciences, University of Basel, Basel, & Swiss Centre for Applied Human Toxicology (SCAHT)
- 17. Department of Pharmaceutical and Pharmacological Sciences, Vrije Universiteit Brussel; Belgium
- 18. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway
Description
Methods to generate evidence for regulatory toxicology are increasingly shifting from classical animal experiments to new approach methodologies (NAMs), with a corresponding need for methods to incorporate them in systematic reviews and other evidence synthesis processes. While many tools have been created for assessing in vitro studies, no single tool is obviously authoritative specifically for assessing the internal validity of in vitro study designs. We therefore aim to address this situation by developing a new tool, INVITES-IN, for evaluating the internal validity of in vitro studies, using methods that ensure we are building on prior work, with a degree of rigour consistent with our intent to provide an authoritative assessment tool.
The current protocol describes three of the four studies that will be performed to create the release version of INVITES-IN. In the first study, evaluation of existing assessment tools will be combined with focus group discussions to identify how characteristics of the design or conduct of an in vitro study can affect its internal validity. In the second study, group agreement on internal validity domains and items of importance for in vitro studies will be identified via a modified Delphi methodology. In the third study, the draft version of INVITES-IN will be created. A separate protocol will be prepared for the fourth study, which includes the user testing, validation of the tool, and collection of users’ experience.