Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014. Otolaryngology 2017, 156: 683-692. PMID: 28116974, DOI: 10.1177/0194599816689666.Peer-Reviewed Original ResearchConceptsPivotal studiesOriginal indicationPrimary endpointClinical evidenceDrug indicationsSupplemental indicationsUS FoodFDA approvalAvailable FDA documentsDouble-blinded studyDrug Administration approvalInformed treatment decisionsPivotal clinical studiesPremarket evidenceOtolaryngologic diseaseMedian enrollmentSurrogate markerAdministration approvalClinical studiesTreatment decisionsMost indicationsDrug AdministrationInitial approvalMultidisciplinary teamPrescription drugsClinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014. Otolaryngology 2017, 156: 285-288. PMID: 28093943, DOI: 10.1177/0194599816684094.Peer-Reviewed Original ResearchConceptsPostapproval studiesPivotal studiesUS FoodPrimary effectiveness end pointAvailable FDA documentsEffectiveness end pointPivotal clinical studiesBenefit-risk assessmentCross-sectional analysisPremarket evidenceMedian durationClinical evidenceDrug Administration premarket approvalsOtolaryngologic diseaseMedian enrollmentClinical studiesHigh-risk medical devicesDrug AdministrationEnd pointHigh-risk devicesFDA documentsOne-thirdTwo-thirdsPremarket approvalFDA