A Modular Approach to the ECVAM Principles on Test Validity

TLDR

ECVAM proposes a flexible yet high‑standard validation framework that extends applicability to diverse tests, technologies, and computational models. The proposal seeks to incorporate existing data as retrospective validation and enable test validity assessment through prospective, retrospective, catch‑up, or combined procedures. Validation is modularized, with each module’s required data defined and emphasized for independent peer review, and the framework supports completing missing information through prospective, retrospective, catch‑up, or combined procedures before peer‑review entry. The modular framework enables independent assessment of a test’s between‑laboratory variability and predictive capacity.

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.