2022
Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study
Moneer O, Daly G, Skydel JJ, Nyhan K, Lurie P, Ross JS, Wallach JD. Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study. The BMJ 2022, 377: e069400. PMID: 35537738, PMCID: PMC9086409, DOI: 10.1136/bmj-2021-069400.Peer-Reviewed Original ResearchConceptsCOVID-19 treatmentObservational studyMeta-epidemiological studyEfficacy outcomesLopinavir-ritonavirLiving reviewTreatment effectsCOVID-19 treatment guidelinesSame interventionCOVID-19Continuous outcomesMeta-analyze evidenceTrial sequential analysisSummary treatment effectsDistribution of sexTreatment guidelinesIndividual RCTsSelection of studiesEvidence DatabasePlacebo comparatorClinical dataStudy demographicsRCTsDichotomous outcomesTherapeutic interventions
2021
Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.
Egilman AC, Kapczynski A, McCarthy ME, Luxkaranayagam AT, Morten CJ, Herder M, Wallach JD, Ross JS. Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration. The Journal Of Law, Medicine & Ethics 2021, 49: 456-485. PMID: 34665102, DOI: 10.1017/jme.2021.67.Peer-Reviewed Original ResearchCharacteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Zhang AD, Puthumana J, Downing NS, Shah ND, Ross JS. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2021, 4: e2113224. PMID: 34110392, PMCID: PMC8193429, DOI: 10.1001/jamanetworkopen.2021.13224.Peer-Reviewed Original ResearchConceptsPrimary efficacy end pointEfficacy end pointPivotal trialsIndication approvalsActive comparatorClinical outcomesSupplemental indicationsUS FoodEnd pointOriginal approvalTherapeutic areasPivotal efficacy trialsCross-sectional studyAdditional clinical dataDrug Administration approvalNew indication approvalsStrength of evidenceAdministration approvalMonths durationClinical dataClinical studiesEfficacy trialsMedian numberCancer indicationsMAIN OUTCOME
2019
Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O'Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand SL, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. American Heart Journal 2019, 218: 110-122. PMID: 31726314, DOI: 10.1016/j.ahj.2019.09.002.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomedical ResearchCardiovascular DiseasesCoronary Artery BypassData AccuracyDatabases, FactualFee-for-Service PlansFemaleFollow-Up StudiesHumansInpatientsInsurance Claim ReviewKaplan-Meier EstimateMaleMedical Record LinkageMedicareMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicRetrospective StudiesStrokeUnited StatesConceptsCardiovascular clinical trialsMyocardial infarctionEvent ratesClinical researchRandomized cardiovascular clinical trialsClinical trialsTrial participantsClinical events committee’s adjudicationsOverall cardiovascular event ratesTreatment effectsAnnual event rateCardiovascular event ratesMedicare inpatient claimsClinical trial dataOutcomes of interestSite-reported eventsCase concordanceCardiovascular outcomesRetrospective studyHigher event ratesInpatient claimsClinical dataMedicare claimsClaims dataDuke Database
2015
Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration
Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration. Otolaryngology 2015, 153: 400-408. PMID: 26044785, DOI: 10.1177/0194599815587508.Peer-Reviewed Original ResearchConceptsClinical dataUS FoodDrug AdministrationPMA pathwayRetrospective cohort studyAdditional clinical dataPremarket approval pathwaySignificant clinical implicationsCohort studyHigh-risk medical devicesMedian numberClinical implicationsMarketing clearanceLife spanAdministrationSubstantial numberPMA applicationApproval pathwaySupplementsFDATherapeutic devicesPathwayPost-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