@article{1976,
  keywords = {cell culture, NAMs, Next generation risk assessment, risk of bias},
  author = {Camilla Svendsen and Paul Whaley and Gunn E. Vist and Trine Husøy and Anna Beronius and Emma Di Consiglio and Ingrid Druwe and Thomas Hartung and Vasiliki I. Hatzi and Sebastian Hoffmann and Carlijn R. Hooijmans and Kyriaki Machera and Joshua F. Robinson and Erwin Roggen and Andrew A. Rooney and Nicolas Roth and Eliana Spilioti and Anastasia Spyropoulou and Olga Tcheremenskaia and Emanuela Testai and Mathieu Vinken and Gro H. Mathisen},
  title = {Protocol for designing INVITES-IN, a tool for assessing the internal validity of in vitro studies},
  abstract = {This protocol describes the design and development of a tool for evaluation of the internal validity of in vitro studies, which is needed to include the data as evidence in systematic reviews and chemical risk assessments. The tool will be designed specifically to be applied to cell culture studies, including, but not restricted to, studies meeting the new approach methodology (NAM) definition. The tool is called INVITES-IN (IN VITro Experimental Studies INternal validity).In this protocol, three of the four studies that will be performed to create the release version of INVITES-IN are described. 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. Bias domains and items considered to be of relevance for in vitro studies will be identified. 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 the tool will be created, based on the data on relevance and importance of bias domains and items collected in Studies 1 and 2. A separate protocol will be prepared for the fourth study, which includes the user testing and validation of the tool, and collection of users’ experience.},
  year = {2023},
  journal = {Evidence-Based Toxicology},
  volume = {1},
  pages = {2232415},
  month = {2023-08-31},
  issn = {null},
  url = {https://doi.org/10.1080/2833373X.2023.2232415},
  doi = {10.1080/2833373X.2023.2232415},
}