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 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 databaseRecallPatientsFDAPostmarketingPremarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyFunding of evidence included within public comments submitted to inform Medicare national coverage determinations
Lu A, Ji R, Magee M, Ross J, Ramachandran R, Redberg R, Dhruva S. Funding of evidence included within public comments submitted to inform Medicare national coverage determinations. Health Affairs Scholar 2024, 2: qxae064. PMID: 38919964, PMCID: PMC11196998, DOI: 10.1093/haschl/qxae064.Peer-Reviewed Original ResearchCenters for Medicare & Medicaid ServicesScientific journal articlesNational Coverage DeterminationPublic commentsCoverage determinationCross-sectional studyMedicare national coverage determinationsJournal articlesMedicare coverage decisionsCoverage of itemsMedicaid ServicesMedicare beneficiariesCommentsMedicare coverageGreater fundingMedicareAuthor disclosuresArticleCoverage decisionsEvaluation of benefitsFunding statementsSupport researchPremarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.Peer-Reviewed Original Research
2023
Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics
Janda G, Wallach J, Dhodapkar M, Ramachandran R, Ross J. Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics. JAMA Internal Medicine 2023, 183: 1271-1273. PMID: 37782514, PMCID: PMC10546285, DOI: 10.1001/jamainternmed.2023.4073.Peer-Reviewed Original ResearchMedical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership
Bhat S, Ross J, Ramachandran R. Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership. JAMA Internal Medicine 2023, 183: 1164-1166. PMID: 37603342, PMCID: PMC10442781, DOI: 10.1001/jamainternmed.2023.2842.Peer-Reviewed Original ResearchUse of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics
Wong A, Mooghali M, Ramachandran R, Ross J, Wallach J. Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics. JAMA Network Open 2023, 6: e2331753. PMID: 37651145, PMCID: PMC10472182, DOI: 10.1001/jamanetworkopen.2023.31753.Peer-Reviewed Original ResearchCross-sectional studyDrug AdministrationUS FoodNovel therapeuticsNew drugsClinical development timesAvailability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022
Mooghali M, Ross J, Kadakia K, Dhruva S. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Internal Medicine 2023, 183: 735-737. PMID: 37184854, PMCID: PMC10186206, DOI: 10.1001/jamainternmed.2023.0727.Peer-Reviewed Original ResearchTrends in the Use of Gabapentinoids and Opioids in the Postoperative Period Among Older Adults
Bongiovanni T, Gan S, Finlayson E, Ross J, Harrison J, Boscardin W, Steinman M. Trends in the Use of Gabapentinoids and Opioids in the Postoperative Period Among Older Adults. JAMA Network Open 2023, 6: e2318626. PMID: 37326989, PMCID: PMC10276300, DOI: 10.1001/jamanetworkopen.2023.18626.Peer-Reviewed Original ResearchConceptsPostoperative periodCross-sectional studyGabapentinoid prescribingSurgical proceduresConcomitant prescribingGabapentinoid prescriptionOlder adultsPostoperative prescribingProcedure typeSerial cross-sectional studyPatients 66 yearsUse of gabapentinoidsProportion of patientsTotal study cohortAdverse drug eventsCommon surgical procedureConcurrent prescribingMultimodal painPostoperative opioidsOpioid prescribingOpioid usePain SocietyStudy cohortMean ageDrug eventsUS Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Ross J, Ramachandran R. US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2023, 6: e2318889. PMID: 37358857, PMCID: PMC10293905, DOI: 10.1001/jamanetworkopen.2023.18889.Peer-Reviewed Original ResearchCharacterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
Mooghali M, Ross J, Kadakia K, Dhruva S. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study. Medical Devices Evidence And Research 2023, 16: 111-122. PMID: 37229515, PMCID: PMC10204764, DOI: 10.2147/mder.s412802.Peer-Reviewed Original ResearchCross-sectional studyClass I medical deviceClass IHigh-risk medical devicesSerious adverse eventsSafety concernsAdverse eventsMedian numberUS FoodRecalled deviceTherapeutic useDevice recallsHigh-risk devicesDevice useSerious safety concernsMedical device recallsMultiple recallsLife-sustaining devicesDevice assessmentUS Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021
Johnston J, Ross J, Ramachandran R. US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. JAMA Internal Medicine 2023, 183: 376-380. PMID: 36780148, PMCID: PMC9926353, DOI: 10.1001/jamainternmed.2022.6444.Peer-Reviewed Original ResearchUS Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics
Eadie A, MacGregor A, Wallach J, Ross J, Herder M. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics. BMJ Evidence-Based Medicine 2023, 28: 151-156. PMID: 36944478, DOI: 10.1136/bmjebm-2022-112005.Peer-Reviewed Original ResearchConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministrationMetrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study
Varma T, Mello M, Ross J, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ Medicine 2023, 2: e000395. PMID: 36936269, PMCID: PMC9951369, DOI: 10.1136/bmjmed-2022-000395.Peer-Reviewed Original ResearchRetrospective cross-sectional studyCross-sectional studyPivotal trialsOlder adultsSectional studyNovel oncology therapeuticsUS cancer populationUS Cancer StatisticsUS patient populationAmerican Cancer SocietyPatient populationCancer populationOncology therapeuticsCancer SocietyCancer statisticsNovel cancer therapeuticsOncology trialsBaseline scoresPatientsUS FoodDrug AdministrationTrial dataStudy participantsTrialsEthics CommitteePrimary care institutional characteristics associated with hypertension awareness, treatment, and control in the China PEACE-Million Persons Project and primary health-care survey: a cross-sectional study
Group C, Zhou T, Wang Y, Zhang H, Wu C, Tian N, Cui J, Bai X, Yang Y, Zhang X, Lu Y, Spatz E, Ross J, Krumholz H, Lu J, Li X, Hu S. Primary care institutional characteristics associated with hypertension awareness, treatment, and control in the China PEACE-Million Persons Project and primary health-care survey: a cross-sectional study. The Lancet Global Health 2023, 11: e83-e94. PMID: 36521957, DOI: 10.1016/s2214-109x(22)00428-4.Peer-Reviewed Original ResearchConceptsProportion of participantsPrimary care institutionsHypertension awarenessPrimary care systemBlood pressureCare institutionsCardiac Events Million Persons ProjectAverage diastolic blood pressureMedical Sciences (CAMS) Innovation FundAverage systolic blood pressureCare systemMillion Persons ProjectHistory of hypertensionDiastolic blood pressurePrimary care surveySystolic blood pressureCardiovascular disease riskBlood pressure measurementsCross-sectional studyParticipant-level dataProportion of physiciansRoutine service deliveryPrimary care roleHealth Care SurveyPublic health services
2022
Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles
Janda G, Khetpal V, Shi X, Ross J, Wallach J. Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles. JAMA Network Open 2022, 5: e2245847. PMID: 36484989, PMCID: PMC9856222, DOI: 10.1001/jamanetworkopen.2022.45847.Peer-Reviewed Original ResearchConceptsPrimary end pointPrimary end point resultsPeer-reviewed journalsClinical studiesEnd pointClinical trialsObservational studyStudy characteristicsEnd point resultsClinical study resultsMost clinical studiesCross-sectional studyHealth-related outcomesSample sizeMAIN OUTCOMEPeer-reviewed publicationsMedRxivEffect estimatesStudy interpretationDiscordant pairsCOVID-19TrialsAnalysis of Patient-Focused Information About Left Atrial Appendage Occlusion on US Hospital Web Pages
Dhruva SS, Ji RZ, Ross JS, Spatz ES, Redberg RF. Analysis of Patient-Focused Information About Left Atrial Appendage Occlusion on US Hospital Web Pages. JAMA Internal Medicine 2022, 182: 1226-1229. PMID: 36190724, PMCID: PMC9531069, DOI: 10.1001/jamainternmed.2022.4287.Peer-Reviewed Original ResearchHospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance
Xiao R, Ross JS, Gross CP, Dusetzina SB, McWilliams JM, Sethi RKV, Rathi VK. Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. JAMA Internal Medicine 2022, 182: 603-611. PMID: 35435948, PMCID: PMC9016607, DOI: 10.1001/jamainternmed.2022.1022.Peer-Reviewed Original ResearchConceptsCancer CenterCancer therapyCross-sectional studyHospital acquisition costNational Cancer InstituteCross-sectional analysisPrimary outcomeSecondary outcomesPrivate health insuranceMAIN OUTCOMEClinical careCancer InstituteMedicare Part B spendingTherapyAcquisition costsPart B spendingHospitalCancer treatmentHealth insuranceFinancial burdenB spendingPatientsSame centerOutcomesPayersSpending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Skydel JJ, Egilman AC, Wallach JD, Ramachandran R, Gupta R, Ross JS. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. JAMA Health Forum 2022, 3: e221158. PMID: 35977252, PMCID: PMC9142876, DOI: 10.1001/jamahealthforum.2022.1158.Peer-Reviewed Original ResearchConceptsSurrogate end pointsCross-sectional studyClinical benefitConfirmation of benefitEnd pointOriginal indicationClinical outcomesUS FoodConfirmatory trialsMedicaid ServicesPrimary end pointUnproven clinical benefitsTrial end pointsClinical trial resultsTypes of drugsPostapproval trialsAccelerated approvalClinical trialsMAIN OUTCOMEDrug AdministrationMedicare Part BStandard approvalConversion statusSupplemental indicationsTrial resultsApprovals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
Gupta R, Morten CJ, Zhu AY, Ramachandran R, Shah ND, Ross JS. Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021. JAMA Health Forum 2022, 3: e221096. PMID: 35977259, PMCID: PMC9123500, DOI: 10.1001/jamahealthforum.2022.1096.Peer-Reviewed Original ResearchConceptsCross-sectional studyNovel drugsTherapeutic valueUS FoodDrug AdministrationWorld Health Organization Model ListGeneric approvalCapsule formMultivariable analysisAccelerated approvalClinical usefulnessMAIN OUTCOMEPrescription drugsBrand-name drugsModel ListEssential medicinesDrugsApproval statusMedicine inclusionFDANovel tabletBlockbuster statusApprovalAdministrationDrug sales