Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016
Roginiel AC, Dhruva SS, Ross JS. Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016. Medicine 2018, 97: e12715. PMID: 30290675, PMCID: PMC6200488, DOI: 10.1097/md.0000000000012715.Peer-Reviewed Original ResearchConceptsOriginal clinical trialsCMS national coverage determinationsNational Coverage DeterminationClinical trialsFDA approvalControl armFDA approval documentsQuality of trialsCross-sectional studySignificant differencesCoverage determinationMedian ageMedian timePivotal trialsQuantity of evidenceInclusion criteriaTrial participantsMedicare populationCMS coverageDrug AdministrationStudy sizeNovel therapeuticsMedicaid ServicesMarketing approvalTrials