2023
A prescription for the US FDA for the regulation of health misinformation
Kadakia K, Beckman A, Krumholz H. A prescription for the US FDA for the regulation of health misinformation. Nature Medicine 2023, 29: 525-527. PMID: 36697774, DOI: 10.1038/s41591-022-02172-9.Peer-Reviewed Original ResearchUse of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls
Kadakia K, Dhruva S, Caraballo C, Ross J, Krumholz H. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA 2023, 329: 136-143. PMID: 36625810, PMCID: PMC9857464, DOI: 10.1001/jama.2022.23279.Peer-Reviewed Original ResearchCross-Sectional StudiesDatabases, FactualDevice ApprovalHumansMedical Device RecallsUnited StatesUnited States Food and Drug Administration
2022
Sensible regulation and clinical implementation of clinical decision support software as a medical device
Mori M, Jarrin R, Lu Y, Kadakia K, Huang C, Ross JS, Krumholz HM. Sensible regulation and clinical implementation of clinical decision support software as a medical device. The BMJ 2022, 376: o525. PMID: 35228206, DOI: 10.1136/bmj.o525.Commentaries, Editorials and LettersMeSH KeywordsDecision Support Systems, ClinicalDevice ApprovalElectronic Health RecordsHumansSoftwareUnited StatesUnited States Food and Drug AdministrationRenewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersMeSH KeywordsDevice ApprovalEquipment and SuppliesEquipment SafetyHumansProduct Surveillance, PostmarketingRisk FactorsUnited StatesUnited States Food and Drug AdministrationConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2020
Regulation of Cardiovascular Therapies During the COVID-19 Public Health Emergency
Vaduganathan M, Butler J, Krumholz HM, Itchhaporia D, Stecker EC, Bhatt DL. Regulation of Cardiovascular Therapies During the COVID-19 Public Health Emergency. Journal Of The American College Of Cardiology 2020, 76: 2517-2521. PMID: 33213730, PMCID: PMC7669239, DOI: 10.1016/j.jacc.2020.09.594.Peer-Reviewed Original ResearchCardiovascular DiseasesCOVID-19EmergenciesHealth Services AccessibilityHumansPublic HealthUnited StatesUnited States Food and Drug AdministrationPostmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Network Open 2020, 3: e2014496. PMID: 32857145, PMCID: PMC7455850, DOI: 10.1001/jamanetworkopen.2020.14496.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicCross-Sectional StudiesDevice ApprovalHumansMedical Device LegislationProduct Surveillance, PostmarketingProstheses and ImplantsUnited StatesUnited States Food and Drug AdministrationAssessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open 2020, 3: e203284. PMID: 32315070, PMCID: PMC7175081, DOI: 10.1001/jamanetworkopen.2020.3284.Peer-Reviewed Original ResearchMeSH KeywordsBiological ProductsClinical Trials as TopicCross-Sectional StudiesDrug ApprovalHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationConceptsPivotal trialsProportion of indicationsIndication approvalsNew drugsUS FoodTrial durationPrimary end pointTherapeutic areasPivotal efficacy trialsCross-sectional studyDrug Administration approvalFast track designationCommon therapeutic areasRecent FDA approvalOrphan designationLonger trial durationAccelerated approvalAdministration approvalClinical trialsMonths durationEfficacy trialsMAIN OUTCOMETherapeutic safetyDrug AdministrationFDA approval
2018
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchMeSH KeywordsCentral Nervous System AgentsClinical Trials as TopicData AccuracyDrug ApprovalHumansMental DisordersPublication BiasRegistriesResearch DesignRetrospective StudiesTime FactorsTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugsFulfilling the Promise of Unique Device Identifiers.
Dhruva SS, Ross JS, Schulz WL, Krumholz HM. Fulfilling the Promise of Unique Device Identifiers. Annals Of Internal Medicine 2018, 169: 183-185. PMID: 29868760, DOI: 10.7326/m18-0526.Commentaries, Editorials and LettersElectronic Data ProcessingEquipment and SuppliesHumansInformation Storage and RetrievalProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationComparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study. BMC Medicine 2018, 16: 45. PMID: 29562926, PMCID: PMC5863466, DOI: 10.1186/s12916-018-1023-9.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersDrug ApprovalEpidemiologic StudiesHumansTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationConceptsPostapproval trialsPivotal trialsActual clinical effectSurrogate markerTrial endpointsLarge treatment effectsPrimary endpointNovel therapeuticsNovel drugsTreatment effectsFDA approvalPatient-relevant outcomesMeta-epidemiological studyStandardized mean differenceTreatment effect sizeClinical effectsResultsBetween 2005Odds ratioDrug trialsSame indicationDrug AdministrationEvidence of differencesMean differenceU.S. FoodDisease
2017
Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationCardiovascular AgentsClinical Trials as TopicDrug ApprovalGovernment RegulationHumansHypoglycemic AgentsOutcome Assessment, Health CareRegistriesResearch DesignTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewersPostmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017, 317: 1854-1863. PMID: 28492899, PMCID: PMC5815036, DOI: 10.1001/jama.2017.5150.Peer-Reviewed Original ResearchMeSH KeywordsBiological ProductsCohort StudiesDrug ApprovalDrug-Related Side Effects and Adverse ReactionsHumansProduct Surveillance, PostmarketingRiskSafetyUnited StatesUnited States Food and Drug AdministrationConceptsNovel therapeuticsSafety eventsAccelerated approvalTherapeutic characteristicsUS FoodDrug AdministrationFDA approvalInitial regulatory approvalClinician decision makingNew safety risksMedian followCohort studyMedian timeMultivariable analysisBoxed warningDrug classesMAIN OUTCOMEClinical practicePostmarket periodPsychiatric diseasesPriority reviewTherapeutic areasOrphan statusPsychiatric therapeuticsBiologicsPostapproval 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 approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkersIs Hemoglobin A1c the Right Outcome for Studies of Diabetes?
Lipska KJ, Krumholz HM. Is Hemoglobin A1c the Right Outcome for Studies of Diabetes? JAMA 2017, 317: 1017-1018. PMID: 28125758, PMCID: PMC5350060, DOI: 10.1001/jama.2017.0029.Commentaries, Editorials and LettersData Desert for Inferior Vena Caval Filters: Limited Evidence, Supervision, and Research
Bikdeli B, Ross JS, Krumholz HM. Data Desert for Inferior Vena Caval Filters: Limited Evidence, Supervision, and Research. JAMA Cardiology 2017, 2: 3-4. PMID: 27806161, DOI: 10.1001/jamacardio.2016.3764.Commentaries, Editorials and LettersClinical Trials as TopicHumansPulmonary EmbolismUnited StatesUnited States Food and Drug AdministrationVena Cava FiltersVenous Thrombosis
2016
Despite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged
Chen SI, Fox ER, Hall MK, Ross JS, Bucholz EM, Krumholz HM, Venkatesh AK. Despite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged. Health Affairs 2016, 35: 798-804. PMID: 27140985, PMCID: PMC6712565, DOI: 10.1377/hlthaff.2015.1157.Peer-Reviewed Original ResearchMeSH KeywordsCritical IllnessDrug IndustryDrug SubstitutionEmergency Service, HospitalFederal GovernmentHumansPrescription DrugsTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsCare drugsNational drug shortageDrug information servicesDrug shortagesAcute unscheduled careAcute care settingShortage of drugsUtah Drug Information ServiceIll patientsEmergency departmentUnscheduled careDrug Administration SafetyCare settingsAdministration safetyStudy periodDrugsDrug supplyCareEarly evidenceTotal numberPatientsParticipation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals
Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals. Trials 2016, 17: 199. PMID: 27079511, PMCID: PMC4832528, DOI: 10.1186/s13063-016-1322-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedClinical Trials as TopicCross-Sectional StudiesDatabases, FactualDrug ApprovalEthnicityFemaleHealth Status DisparitiesHealthcare DisparitiesHumansMaleMiddle AgedMinority GroupsPatient SelectionSex FactorsTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsSubgroup efficacy analysesPivotal trialsEfficacy analysisNovel therapeuticsSubgroup analysisTrial participantsU.S. FoodMean proportionAvailable FDA documentsCross-sectional studyDrug Administration approvalBasis of approvalYears of ageTrial patientsElderly patientsMedian ageBlack patientsAsian patientsAdministration approvalClinical studiesFDA reviewersPatientsHispanic participantsTrialsDemographic characteristics
2015
Characterizing the US FDA's approach to promoting transformative innovation
Downing NS, Krumholz HM, Ross JS, Shah ND. Characterizing the US FDA's approach to promoting transformative innovation. Nature Reviews Drug Discovery 2015, 14: 740-741. PMID: 26435528, DOI: 10.1038/nrd4734.Peer-Reviewed Original ResearchAnimalsDrug ApprovalGovernment RegulationHumansInventionsUnited StatesUnited States Food and Drug AdministrationCharacteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicDevice ApprovalEquipment and SuppliesEquipment SafetyHumansIndustryProduct Surveillance, PostmarketingResearch DesignResearch PersonnelRiskUnited StatesUnited States Food and Drug AdministrationConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2014
Trends in adoption of Wingspan stents
Gupta A, Krumholz H. Trends in adoption of Wingspan stents. The BMJ 2014, 348: g1552. PMID: 24554175, DOI: 10.1136/bmj.g1552.Peer-Reviewed Original Research