Post-marketing assessment of the safety of strontium ranelate; a novel case-only approach to the early detection of adverse drug reactions

摘要

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECTRandomized controlled trials are the gold standard of drug efficacy assessment, but have limited power to assess adverse drug reactions.Observational data derived from larger populations of patients are often affected by confounding variables, many of which are difficult to measure or simply not known.