A combined pre-clinical meta-analysis and randomized confirmatory trial approach to improve data validity for therapeutic target validation

Sci Rep. 2015 Aug 27:5:13428. doi: 10.1038/srep13428.

Abstract

Biomedical research suffers from a dramatically poor translational success. For example, in ischemic stroke, a condition with a high medical need, over a thousand experimental drug targets were unsuccessful. Here, we adopt methods from clinical research for a late-stage pre-clinical meta-analysis (MA) and randomized confirmatory trial (pRCT) approach. A profound body of literature suggests NOX2 to be a major therapeutic target in stroke. Systematic review and MA of all available NOX2(-/y) studies revealed a positive publication bias and lack of statistical power to detect a relevant reduction in infarct size. A fully powered multi-center pRCT rejects NOX2 as a target to improve neurofunctional outcomes or achieve a translationally relevant infarct size reduction. Thus stringent statistical thresholds, reporting negative data and a MA-pRCT approach can ensure biomedical data validity and overcome risks of bias.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • Animals
  • Brain Infarction / complications
  • Brain Infarction / pathology
  • Female
  • Mice, Inbred C57BL
  • Molecular Targeted Therapy*
  • NADPH Oxidases / metabolism*
  • Publication Bias
  • Randomized Controlled Trials as Topic*
  • Reproducibility of Results
  • Research Report
  • Statistics as Topic
  • Stroke / complications
  • Stroke / enzymology

Substances

  • NADPH Oxidases