The Next Generation of Drug Safety Science: Coupling Detection, Corroboration, and Validation to Discover Novel Drug Effects and Drug-Drug Interactions

Clin Pharmacol Ther. 2018 Feb;103(2):177-179. doi: 10.1002/cpt.949.


Rare adverse drug reactions and drug-drug interactions (DDIs) are difficult to detect in randomized trials and impossible to prove using observational studies. We must ascribe to a new way of conducting research that has the efficiency of a retrospective analysis and the rigor of a prospective trial. This can be achieved by integrating observational data from humans with laboratory experiments in model systems. The former establishes clinical significance and the latter supports causality.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Animals
  • Data Mining / methods*
  • Databases, Factual
  • Drug Development / methods*
  • Drug Discovery / methods*
  • Drug Interactions
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Evidence-Based Medicine / methods*
  • Humans
  • Learning
  • Models, Animal
  • Models, Theoretical
  • Patient Safety
  • Pharmacovigilance*
  • Reproducibility of Results
  • Risk Assessment
  • Translational Research, Biomedical / methods*