Osman Moneer
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Featured Publications
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 interventionsAligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program
Moneer O, Rathi V, Johnston J, Ross J, Dhruva S. Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program. JAMA Cardiology 2023, 8: 1174-1181. PMID: 37878306, DOI: 10.1001/jamacardio.2023.3819.Peer-Reviewed Original ResearchDirect-to-consumer personal genomic tests need better regulation
Moneer O, Miller JE, Shah ND, Ross JS. Direct-to-consumer personal genomic tests need better regulation. Nature Medicine 2021, 27: 940-943. PMID: 34017136, DOI: 10.1038/s41591-021-01368-9.Commentaries, Editorials and Letters
2024
Medical Devices Applying for Outpatient Medicare Supplemental Payments
Moneer O, Johnston J, Rathi V, Ross J, Dhruva S. Medical Devices Applying for Outpatient Medicare Supplemental Payments. JAMA Health Forum 2024, 5: e244016. PMID: 39546305, PMCID: PMC11568453, DOI: 10.1001/jamahealthforum.2024.4016.Peer-Reviewed Original ResearchConceptsCenters for Medicare & Medicaid ServicesMedicare beneficiariesUS Centers for Medicare & Medicaid ServicesCross-sectional studyCross-sectional analysisPatient demographic characteristicsClinical decision-makingMedicaid ServicesMain OutcomesHispanic patientsClinical evidence requirementsPremarket clinical studyOutpatient settingOutpatient paymentsTraditional pathwaysMedicareSupplemental paymentsFiscal yearTransitional pass-through paymentsReimbursementDemographic dataEffectiveness end pointPathway applicationClinical studiesAuthorization pathwaysHPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates
Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. HPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates. Value In Health 2024, 27: s214. DOI: 10.1016/j.jval.2024.03.1178.Peer-Reviewed Original Research
2022
Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016
Brown B, Mitra-Majumdar M, Darrow J, Moneer O, Pham C, Avorn J, Kesselheim A. Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. JAMA Internal Medicine 2022, 182: 1223-1226. PMID: 36190713, PMCID: PMC9531062, DOI: 10.1001/jamainternmed.2022.4226.Peer-Reviewed Original ResearchGenerating evidence during a pandemic: what’s reliable?
Wallach JD, Moneer O, Ross JS. Generating evidence during a pandemic: what’s reliable? The BMJ 2022, 377: o1229. PMID: 35577370, DOI: 10.1136/bmj.o1229.Commentaries, Editorials and LettersNew Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence
Moneer O, Brown BL, Avorn J, Darrow JJ, Mitra-Majumdar M, Joyce KW, Ross M, Pham C, Kesselheim AS. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence. Drug Safety 2022, 45: 305-318. PMID: 35182362, DOI: 10.1007/s40264-022-01152-9.Peer-Reviewed Original Research
2021
Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020
Moneer O, Lee CC, Avorn J, Kesselheim AS. Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020. JAMA Network Open 2021, 4: e218530. PMID: 33929526, PMCID: PMC8087952, DOI: 10.1001/jamanetworkopen.2021.8530.Peer-Reviewed Original Research
2020
An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19
Kesselheim AS, Darrow JJ, Kulldorff M, Brown BL, Mitra-Majumdar M, Lee CC, Moneer O, Avorn J. An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19. Health Affairs 2020, 40: 25-32. PMID: 33211535, DOI: 10.1377/hlthaff.2020.01620.Peer-Reviewed Original ResearchConceptsNew vaccinesVaccine Adverse Event Reporting SystemFDA Vaccine Adverse Event Reporting SystemVaccine Safety DatalinkAdverse Event Reporting SystemEmergency use authorizationCoronavirus disease 2019Assessment of vaccinesEvent Reporting SystemImmune system responseAdverse eventsPivotal trialsVaccine evaluationSurrogate markerSurrogate outcomesDisease 2019Vaccine availabilityDrug AdministrationVaccine developmentVaccineDisease controlSafety surveillanceCOVID-19One-thirdReporting system
News
News
- June 27, 2024
Trust-Centered Approach to Deprescribing in Older Patients
- May 27, 2024
Expert Clinicians Offer Perspective on Clinical Reasoning Strategies
- May 27, 2024
Unhealthy Alcohol Use Among Men who have Sex with Men Taking PrEP for HIV Prevention
- May 27, 2024
Tick-Borne Diseases in the United States: An Escalating Challenge