2021
Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019
Elliott MH, Skydel JJ, Dhruva SS, Ross JS, Wallach JD. Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019. JAMA Internal Medicine 2021, 181: 282-284. PMID: 33226398, PMCID: PMC7684521, DOI: 10.1001/jamainternmed.2020.4799.Peer-Reviewed Original Research
2017
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchMeSH KeywordsControlled Clinical Trials as TopicDrug ApprovalHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers