Embracing Transparency Through Data Sharing


Authored by  S Boue, M Byrne*, AW Hayes, J Hoeng, M Peitsch

Published in International Journal of Toxicology    
* This author is not affiliated with PMI.
Abstract

Low rates of reproducibility and translatability of data from nonclinical research have been reported. Major causes of irreproducibility include oversights in study design, failure to characterize reagents and protocols, a lack of access to detailed methods and data, and an absence of universally accepted and applied standards and guidelines. Specific areas of concern include uncharacterized antibodies and cell lines, the use of inappropriate sampling and testing protocols, a lack of transparency and access to raw data, and deficiencies in the translatability of findings to the clinic from studies using animal models of disease. All stakeholders—academia, industry, funding agencies, regulators, nonprofit entities, and publishers—are encouraged to play active roles in addressing these challenges by formulating and promoting access to best practices and standard operating procedures and validating data collaboratively at each step of the biomedical research life cycle.