TY - JOUR
KW - cell culture
KW - NAMs
KW - Next generation risk assessment
KW - risk of bias
AU - Camilla Svendsen
AU - Paul Whaley
AU - Gunn E. Vist
AU - Trine Husøy
AU - Anna Beronius
AU - Emma Di Consiglio
AU - Ingrid Druwe
AU - Thomas Hartung
AU - Vasiliki I. Hatzi
AU - Sebastian Hoffmann
AU - Carlijn R. Hooijmans
AU - Kyriaki Machera
AU - Joshua F. Robinson
AU - Erwin Roggen
AU - Andrew A. Rooney
AU - Nicolas Roth
AU - Eliana Spilioti
AU - Anastasia Spyropoulou
AU - Olga Tcheremenskaia
AU - Emanuela Testai
AU - Mathieu Vinken
AU - Gro H. Mathisen
AB - 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.
BT - Evidence-Based Toxicology
DA - 2023-08-31
DO - 10.1080/2833373X.2023.2232415
IS - 1
N2 - 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.
PY - 2023
EP - 2232415
T2 - Evidence-Based Toxicology
TI - Protocol for designing INVITES-IN, a tool for assessing the internal validity of in vitro studies
UR - https://doi.org/10.1080/2833373X.2023.2232415
VL - 1
Y2 - 2023-09-12
SN - null
ER -