2024
Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024, 177: 1499-1508. PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketingFibrinolytic Agents in Thromboembolic Diseases: Historical Perspectives and Approved Indications
Rashedi S, Greason C, Sadeghipour P, Talasaz A, O'Donoghue M, Jimenez D, Monreal M, Anderson C, Elkind M, Kreuziger L, Lang I, Goldhaber S, Konstantinides S, Piazza G, Krumholz H, Braunwald E, Bikdeli B. Fibrinolytic Agents in Thromboembolic Diseases: Historical Perspectives and Approved Indications. Seminars In Thrombosis And Hemostasis 2024, 50: 773-789. PMID: 38428841, DOI: 10.1055/s-0044-1781451.Peer-Reviewed Original ResearchST-segment elevation myocardial infarctionTissue plasminogen activatorFood and Drug AdministrationFibrinolytic agentsThromboembolic diseasePlasminogen activatorFood and Drug Administration approvalArterial thromboembolic eventsElevation myocardial infarctionCentral venous access device occlusionPlasma half-lifeU.S. Food and Drug AdministrationAcute ischemic strokePulmonary embolismThromboembolic eventsHemodynamic compromiseDevice occlusionTreated patientsRecanalize occluded vesselsActive protease plasminDrug AdministrationMyocardial infarctionApproved indicationsOccluded vesselIschemic stroke
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 Research
2020
SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity
Vogels CBF, Watkins AE, Harden CA, Brackney DE, Shafer J, Wang J, Caraballo C, Kalinich CC, Ott IM, Fauver JR, Kudo E, Lu P, Venkataraman A, Tokuyama M, Moore AJ, Muenker MC, Casanovas-Massana A, Fournier J, Bermejo S, Campbell M, Datta R, Nelson A, Team Y, Anastasio K, Askenase M, Batsu M, Bickerton S, Brower K, Bucklin M, Cahill S, Cao Y, Courchaine E, DeIuliis G, Earnest R, Geng B, Goldman-Israelow B, Handoko R, Khoury-Hanold W, Kim D, Knaggs L, Kuang M, Lapidus S, Lim J, Linehan M, Lu-Culligan A, Martin A, Matos I, McDonald D, Minasyan M, Nakahata M, Naushad N, Nouws J, Obaid A, Odio C, Oh J, Omer S, Park A, Park H, Peng X, Petrone M, Prophet S, Rice T, Rose K, Sewanan L, Sharma L, Shaw A, Shepard D, Smolgovsky M, Sonnert N, Strong Y, Todeasa C, Valdez J, Velazquez S, Vijayakumar P, White E, Yang Y, Dela Cruz C, Ko A, Iwasaki A, Krumholz H, Matheus J, Hui P, Liu C, Farhadian S, Sikka R, Wyllie A, Grubaugh N. SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity. Med 2020, 2: 263-280.e6. PMID: 33521748, PMCID: PMC7836249, DOI: 10.1016/j.medj.2020.12.010.Peer-Reviewed Original ResearchConceptsEmergency use authorizationSARS-CoV-2 testingSARS-CoV-2 screeningSARS-CoV-2 testing capacitySupply chain shortagesHospital cohortNasopharyngeal swabsHealthy individualsDrug AdministrationHigh positive agreementQRT-PCR assaysDiagnostic testsU.S. FoodSafe reopeningTesting capacityGlobal healthPositive agreementFast GrantLower ratesSalivaNucleic acid extractionSwabsValid alternativeAssay costsCollection tubesAssessment 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 ResearchConceptsPivotal 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 approvalConfidentiality Orders and Public Interest in Drug and Medical Device Litigation
Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A. Confidentiality Orders and Public Interest in Drug and Medical Device Litigation. JAMA Internal Medicine 2020, 180: 292-299. PMID: 31657836, DOI: 10.1001/jamainternmed.2019.5161.Commentaries, Editorials and LettersConceptsLegal practicePublic interestMedical device litigationImportant public health informationLegal standardsMedical device manufacturersLitigationSpecial communicationCourtObscure patternsCompany marketingMedical expertsRulesPublic health informationDevice manufacturersPublic healthSuccessful effortsLitigantsPracticePlaintiffsLawsuitsCertain typesInterestAccessDrug Administration
2018
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
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 ResearchConceptsPostapproval 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
Postmarket 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 ResearchConceptsNovel 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 ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers
2015
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
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 ResearchConceptsPrimary 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 documentsMonthsPostmarketPost-market clinical research conducted by medical device manufacturers: a cross-sectional survey
Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical Devices Evidence And Research 2015, Volume 8: 241-249. PMID: 26060416, PMCID: PMC4454210, DOI: 10.2147/mder.s82964.Peer-Reviewed Original Research
2014
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food
2013
Trends in Intracranial Stenting Among Medicare Beneficiaries in the United States, 2006–2010
Gupta A, Desai MM, Kim N, Bulsara KR, Wang Y, Krumholz HM. Trends in Intracranial Stenting Among Medicare Beneficiaries in the United States, 2006–2010. Journal Of The American Heart Association 2013, 2: e000084. PMID: 23588099, PMCID: PMC3647283, DOI: 10.1161/jaha.113.000084.Peer-Reviewed Original ResearchConceptsIntracranial stentingMortality rateService beneficiariesICD-9-CM procedure codesPrincipal discharge diagnosis codeOverall hospitalization rateDischarge diagnosis codesHumanitarian Device Exemption approvalAcute care hospitalsHumanitarian Device ExemptionCare hospitalIntracranial angioplastyHospitalization ratesICS useSubarachnoid hemorrhageDiagnosis codesOperative rateProcedure ratesMedicare feeMedicare beneficiariesInsufficient evidenceICS procedureDrug AdministrationCerebral aneurysmsMedicaid Services
2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority
2010
Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone
Shah ND, Montori VM, Krumholz HM, Tu K, Alexander GC, Jackevicius CA. Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone. New England Journal Of Medicine 2010, 363: 2081-2084. PMID: 21083379, DOI: 10.1056/nejmp1011042.Peer-Reviewed Original ResearchConceptsBoxed warningUse of rosiglitazoneRisk of MIRosiglitazone useDrug AdministrationDrug rosiglitazoneRosiglitazone