Consensus workshop on "Quality standards for publications dealing with in vitro test systems"

Date and location:

12th March 2012, San Francisco (SOT satellite meeting)

Background:

Many concerns have been raised on the quality of the data presentation in scientific publications (1). This is of particular concern in toxicology. For instance, in the field of developmental toxicology, this discussion has led to recommendations of editors on data requirements (2). For animal experiments in general, the ARRIVE guidelines have been worked out for minimum publication standards (4, 5), and the specific problem of underpowered studies has been discussed (6). For in vitro models, recommendations are available for good cell culture practice (7,8), and several guidelines are available, e.g. for system validation (OECD GD 34). Recommendations have also been issued for aspects to consider when test systems are being established (9, 10). However, a comprehensive set of guidelines would help authors, referees and editors.

Scope:

Therefore, recommendations will be given for points to consider with respect to statistical planning and presentation of data on alternative methods in the field of toxicology. General guidelines of best practice will be compiled.

Procedure:

A draft document will be assembled in an open process, and discussed during a workshop in March 2012 in San Francisco (satellite to SOT meeting). After a public feedback phase, a consensus report with all contributors as authors will be published.

References:

1. Mullard, A., Reliability of 'new drug target' claims called into question. Nat Rev Drug Discov, 2011. 10(9): p. 643-4.

2. Maurissen, J., Practical considerations on the design, execution and analysis of developmental neurotoxicity studies to be published in Neurotoxicology and Teratology. Neurotoxicol Teratol, 2010. 32(2): p. 121-3.

4. Kilkenny, C., et al., Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol, 2010. 8(6): p. e1000412.

5. Kilkenny, C., et al., Survey of the quality of experimental design, statistical analysis and reporting of research using animals. PLoS One, 2009. 4(11): p. e7824.

6. Macleod, M., Why animal research needs to improve. Nature, 2011. 477(7366): p. 511.

7. Coecke S, Balls M, Bowe G, Davis J, Gstraunthaler G, Hartung T, Hay R, Merten OW, Price A, Schechtman L, StaceyG, Stokes W; Second ECVAM Task Force on Good Cell Culture Practice. Guidance on good cell culture practice. Altern Lab Anim. 2005 Jun;33(3):261-87. PubMed PMID: 16180980.

8. Hartung T, Balls M, Bardouille C, Blanck O, Coecke S, Gstraunthaler G, Lewis D; First ECVAM Good Cell CulturePractice Task Force. Good Cell Culture Practice. Altern Lab Anim. 2002 Jul-Aug;30(4):407-14

9. Crofton, K.M., et al., Developmental neurotoxicity testing: recommendations for developing alternative methods for the screening and prioritization of chemicals. ALTEX, 2011. 28(1): p. 9-15.

10. Leist, M., L. Efremova, and C. Karreman, Food for thought ... considerations and guidelines for basic test method descriptions in toxicology. ALTEX, 2010. 27(4): p. 309-17.