Evidence-based medicine and drug-eluting stents.
Successful implementation of evidence-based medicine in the development of high-risk medical devices requires a methodical scientific approach. However, even when research evidence is available from randomised controlled studies, it can be difficult to translate clinical evidence into regulatory and clinical decisions. Drug-eluting stents are used as an example to illustrate this principle.
O'Dwyer
John
J
National Standards Authority of Ireland, Glasnevin, Dublin, Ireland. john.odwyer@nsai.ie
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D004867:Equipment Design; D019544:Equipment Failure Analysis / Q000379:methods* / Q000592:standards; D005062:European Union; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D015918:Infusion Pumps, Implantable / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000639:trends*; D015607:Stents / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards