A modular approach to the ECVAM principles on test validity

Thomas Hartung, Susanne Bremer, Silvia Casati, Sandra Coecke, Raffaella Corvi, Salvador Fortaner, Laura Gribaldo, Marlies Halder, Sebastian Hoffmann, Annett Janusch Roi, Pilar Prieto, Enrico Sabbioni, Laurie Scott, Andrew Worth, Valérie Zuang

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)467-472
Number of pages6
JournalATLA Alternatives to Laboratory Animals
Volume32
Issue number5
StatePublished - Nov 2004
Externally publishedYes

Fingerprint

Peer Review
Expert systems
testing
peers
Expert Systems
Quantitative Structure-Activity Relationship
Validation Studies
Genomics
methodology
Computer Simulation
Proteomics
quantitative structure-activity relationships
expert systems
Prospective Studies
Technology
proteomics
genomics
Thinking

Keywords

  • In silico
  • In vitro
  • In vivo
  • Modular approach
  • QSARs
  • Test validity
  • Validation

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • veterinary(all)

Cite this

Hartung, T., Bremer, S., Casati, S., Coecke, S., Corvi, R., Fortaner, S., ... Zuang, V. (2004). A modular approach to the ECVAM principles on test validity. ATLA Alternatives to Laboratory Animals, 32(5), 467-472.

A modular approach to the ECVAM principles on test validity. / Hartung, Thomas; Bremer, Susanne; Casati, Silvia; Coecke, Sandra; Corvi, Raffaella; Fortaner, Salvador; Gribaldo, Laura; Halder, Marlies; Hoffmann, Sebastian; Roi, Annett Janusch; Prieto, Pilar; Sabbioni, Enrico; Scott, Laurie; Worth, Andrew; Zuang, Valérie.

In: ATLA Alternatives to Laboratory Animals, Vol. 32, No. 5, 11.2004, p. 467-472.

Research output: Contribution to journalArticle

Hartung, T, Bremer, S, Casati, S, Coecke, S, Corvi, R, Fortaner, S, Gribaldo, L, Halder, M, Hoffmann, S, Roi, AJ, Prieto, P, Sabbioni, E, Scott, L, Worth, A & Zuang, V 2004, 'A modular approach to the ECVAM principles on test validity', ATLA Alternatives to Laboratory Animals, vol. 32, no. 5, pp. 467-472.
Hartung T, Bremer S, Casati S, Coecke S, Corvi R, Fortaner S et al. A modular approach to the ECVAM principles on test validity. ATLA Alternatives to Laboratory Animals. 2004 Nov;32(5):467-472.
Hartung, Thomas ; Bremer, Susanne ; Casati, Silvia ; Coecke, Sandra ; Corvi, Raffaella ; Fortaner, Salvador ; Gribaldo, Laura ; Halder, Marlies ; Hoffmann, Sebastian ; Roi, Annett Janusch ; Prieto, Pilar ; Sabbioni, Enrico ; Scott, Laurie ; Worth, Andrew ; Zuang, Valérie. / A modular approach to the ECVAM principles on test validity. In: ATLA Alternatives to Laboratory Animals. 2004 ; Vol. 32, No. 5. pp. 467-472.
@article{6cba71aa30e34af191f37b7876853359,
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.",
keywords = "In silico, In vitro, In vivo, Modular approach, QSARs, Test validity, Validation",
author = "Thomas Hartung and Susanne Bremer and Silvia Casati and Sandra Coecke and Raffaella Corvi and Salvador Fortaner and Laura Gribaldo and Marlies Halder and Sebastian Hoffmann and Roi, {Annett Janusch} and Pilar Prieto and Enrico Sabbioni and Laurie Scott and Andrew Worth and Val{\'e}rie Zuang",
year = "2004",
month = "11",
language = "English (US)",
volume = "32",
pages = "467--472",
journal = "ATLA Alternatives to Laboratory Animals",
issn = "0261-1929",
publisher = "FRAME",
number = "5",

}

TY - JOUR

T1 - A modular approach to the ECVAM principles on test validity

AU - Hartung, Thomas

AU - Bremer, Susanne

AU - Casati, Silvia

AU - Coecke, Sandra

AU - Corvi, Raffaella

AU - Fortaner, Salvador

AU - Gribaldo, Laura

AU - Halder, Marlies

AU - Hoffmann, Sebastian

AU - Roi, Annett Janusch

AU - Prieto, Pilar

AU - Sabbioni, Enrico

AU - Scott, Laurie

AU - Worth, Andrew

AU - Zuang, Valérie

PY - 2004/11

Y1 - 2004/11

N2 - 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.

AB - 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.

KW - In silico

KW - In vitro

KW - In vivo

KW - Modular approach

KW - QSARs

KW - Test validity

KW - Validation

UR - http://www.scopus.com/inward/record.url?scp=19944430250&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=19944430250&partnerID=8YFLogxK

M3 - Article

VL - 32

SP - 467

EP - 472

JO - ATLA Alternatives to Laboratory Animals

JF - ATLA Alternatives to Laboratory Animals

SN - 0261-1929

IS - 5

ER -