title: A modular approach to the ECVAM principles on test validity.
abstract: The European Centre for the Validation of Alternative Methods (ECVAM) proposes to make the validation process more flexible, while maintaining its high standards. The various aspects of validation are broken down into independent modules, and the information necessary to complete each module is defined. The data required to assess test validity in an independent peer review, not the process, are thus emphasised. Once the information to satisfy all the modules is complete, the test can enter the peer-review process. In this way, the between-laboratory variability and predictive capacity of a test can be assessed independently. Thinking in terms of validity principles will broaden the applicability of the validation process to a variety of tests and procedures, including the generation of new tests, new technologies (for example, genomics, proteomics), computer-based models (for example, quantitative structure-activity relationship models), and expert systems. This proposal also aims to take into account existing information, defining this as retrospective validation, in contrast to a prospective validation study, which has been the predominant approach to date. This will permit the assessment of test validity by completing the missing information via the relevant validation procedure: prospective validation, retrospective validation, catch-up validation, or a combination of these procedures.
authors.affiliation: ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, 21020 Ispra (VA), Italy. thomas.hartung@cec.eu.int
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartung
authors.forename: Susanne
authors.initials: S
authors.lastname: Bremer
authors.forename: Silvia
authors.initials: S
authors.lastname: Casati
authors.forename: Sandra
authors.initials: S
authors.lastname: Coecke
authors.forename: Raffaella
authors.initials: R
authors.lastname: Corvi
authors.forename: Salvador
authors.initials: S
authors.lastname: Fortaner
authors.forename: Laura
authors.initials: L
authors.lastname: Gribaldo
authors.forename: Marlies
authors.initials: M
authors.lastname: Halder
authors.forename: Sebastian
authors.initials: S
authors.lastname: Hoffmann
authors.forename: Annett Janusch
authors.initials: AJ
authors.lastname: Roi
authors.forename: Pilar
authors.initials: P
authors.lastname: Prieto
authors.forename: Enrico
authors.initials: E
authors.lastname: Sabbioni
authors.forename: Laurie
authors.initials: L
authors.lastname: Scott
authors.forename: Andrew
authors.initials: A
authors.lastname: Worth
authors.forename: Valérie
authors.initials: V
authors.lastname: Zuang
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods / Q000592:standards*; D003198:Computer Simulation; D005060:Europe; D005103:Expert Systems; D007753:Laboratories; D010380:Peer Review; D015203:Reproducibility of Results