A modular approach to the ECVAM principles on test validity
A modular approach to the ECVAM principles on test validity
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DOI：
10.1177/026119290403200503
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发表时间：
2004-11-01
影响因子：
2.7
通讯作者：
Zuang, V
中科院分区：
文献类型：
--
作者：
Hartung, T;Bremer, S;Zuang, V
欧洲替代方法验证中心（ECVAM）建议使验证过程更加灵活，同时保持其高标准。验证的各个方面被分解为独立的模块，并定义了完成每个模块所需的信息。因此，强调的是在独立同行评审中评估测试有效性所需的数据，而不是过程。一旦满足所有模块的信息完成，测试就可以进入同行评审过程。通过这种方式，可以独立评估实验室间变异性和测试的预测能力。从有效性原则的角度来思考，可以将验证过程的适用性扩大到各种测试和程序，包括新测试、新技术（例如基因组学、蛋白质组学）、基于计算机的模型（例如定量结构-活性关系模型）和专家系统的产生。该提案还旨在考虑现有信息，将其定义为回顾性验证，而不是前瞻性验证研究，这是迄今为止的主要方法。这将允许通过相关验证程序（前瞻性验证、回顾性验证、追赶验证或这些程序的组合）完成缺失信息来评估测试有效性。
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.