The impact of preclinical irreproducibility on drug development

Clin Pharmacol Ther. 2015 Jan;97(1):16-8. doi: 10.1002/cpt.9. Epub 2014 Dec 2.


The development of novel therapeutics depends and builds upon the validity and reproducibility of previously published data and findings. Yet irreproducibility is pervasive in preclinical life science research and can be traced to cumulative errors or flaws in several areas, including reference materials, study design, laboratory protocols, and data collection and analysis. The expanded development and use of consensus-based standards and well-documented best practices is needed to both enhance reproducibility and drive therapeutic innovations.

MeSH terms

  • Data Collection / methods
  • Data Collection / standards
  • Drug Design*
  • Drug Evaluation, Preclinical / methods*
  • Humans
  • Reproducibility of Results
  • Research Design / standards*