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

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.