Featured Publications
The Critical Shortage of Iodinated Contrast Material — Will Value Prevail?
Tu LH, Miller JE, Forman HP. The Critical Shortage of Iodinated Contrast Material — Will Value Prevail? New England Journal Of Medicine 2022, 387: 491-493. PMID: 35704416, DOI: 10.1056/nejmp2206996.Peer-Reviewed Original ResearchEthical considerations in international clinical trial site selection.
Miller J, Millum J. Ethical considerations in international clinical trial site selection. BMJ Global Health 2022, 7 PMID: 35387769, PMCID: PMC8987699, DOI: 10.1136/bmjgh-2021-008012.Peer-Reviewed Original ResearchAccess to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials
Ramachandran R, Ross JS, Miller JE. Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials. JAMA Network Open 2021, 4: e2134233. PMID: 34792596, PMCID: PMC8603077, DOI: 10.1001/jamanetworkopen.2021.34233.Peer-Reviewed Original ResearchEvaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs
Miller JE, Mello MM, Wallach JD, Gudbranson EM, Bohlig B, Ross JS, Gross CP, Bach PB. Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs. JAMA Network Open 2021, 4: e217075. PMID: 33950209, PMCID: PMC8100865, DOI: 10.1001/jamanetworkopen.2021.7075.Peer-Reviewed Original ResearchConceptsFDA approvalHigh-income countriesDrug approvalIncome countriesNovel drugsDrug Administration (FDA) drug approvalsRegulatory agency websitesCross-sectional analysisProportion of drugPrimary outcomeFDA drug approvalsProportion of countriesDrug trialsMAIN OUTCOMEUS FoodClinical researchCountry income levelLow-income countriesMarketing approvalTrialsGoogle ScholarDrugsDrug companiesApprovalMedian
2024
Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022
Swanson M, Uyeki C, Yoder S, Dhruva S, Miller J, Ross J. Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022. Medical Devices Evidence And Research 2024, 17: 165-172. PMID: 38707869, PMCID: PMC11067925, DOI: 10.2147/mder.s457152.Peer-Reviewed Original ResearchFood and Drug AdministrationHigh-risk cardiovascular devicesSubgroup analysisPremarketing studiesUS Food and Drug AdministrationResults of subgroup analysisParticipation of older adultsStudy participantsClinical trialsSocioeconomic positionTrial populationDrug AdministrationStudy populationConduction of subgroup analysisDemographic dataOlder adultsReporting of demographicsSubgroupsPatients' socioeconomic position.PatientsTrials
2023
Clinical Trial Diversity: A Bend in the Arc Toward Justice
Tannenbaum S, Miller J. Clinical Trial Diversity: A Bend in the Arc Toward Justice. JCO Precision Oncology 2023, 7: e2300380. PMID: 37725783, DOI: 10.1200/po.23.00380.Peer-Reviewed Original ResearchTransparency of Results Reporting in Cancer Clinical Trials
Kao J, Ross J, Miller J. Transparency of Results Reporting in Cancer Clinical Trials. JAMA Network Open 2023, 6: e2328117. PMID: 37556143, PMCID: PMC10413165, DOI: 10.1001/jamanetworkopen.2023.28117.Peer-Reviewed Original ResearchClinical Trial Diversity—Will We Know It When We See It?
Varma T, Gross C, Miller J. Clinical Trial Diversity—Will We Know It When We See It? JAMA Oncology 2023, 9: 765-767. PMID: 37022678, DOI: 10.1001/jamaoncol.2023.0143.Peer-Reviewed Original ResearchWhat is Fair Representation in Research?
Miller J, Latham S. What is Fair Representation in Research? The American Journal Of Bioethics 2023, 23: 89-91. PMID: 37220359, DOI: 10.1080/15265161.2023.2201543.Peer-Reviewed Original ResearchRanking pharmaceutical companies on clinical trial diversity
Varma T, Miller J. Ranking pharmaceutical companies on clinical trial diversity. The BMJ 2023, 380: p334. PMID: 36764687, DOI: 10.1136/bmj.p334.Peer-Reviewed Original Research
2022
Drug repurposing: a systematic review on root causes, barriers and facilitators
Krishnamurthy N, Grimshaw AA, Axson SA, Choe SH, Miller JE. Drug repurposing: a systematic review on root causes, barriers and facilitators. BMC Health Services Research 2022, 22: 970. PMID: 35906687, PMCID: PMC9336118, DOI: 10.1186/s12913-022-08272-z.Peer-Reviewed Original ResearchConceptsData accessIntellectual property challengesDesign decisionsCompound databasesExamples of companiesBusiness reasonsCore approachRoot causeMulti-partner collaborationsText termsFull potentialText reviewBusiness Source CompleteResourcesAccessCollaborationDatabaseSuperiorityMore informationSafety problemsDiversity in clinical research: public health and social justice imperatives
Varma T, Jones CP, Oladele C, Miller J. Diversity in clinical research: public health and social justice imperatives. Journal Of Medical Ethics 2022, 49: 200-203. PMID: 35428737, DOI: 10.1136/medethics-2021-108068.Peer-Reviewed Original Research
2021
Implementation of 21st Century Cures Act Expanded Access Policies Requirements
Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clinical Pharmacology & Therapeutics 2021, 110: 1579-1584. PMID: 34431083, DOI: 10.1002/cpt.2401.Peer-Reviewed Original ResearchClinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis
Axson S, Mello MM, Lincow D, Yang C, Gross C, Ross JS, Miller J. Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ Open 2021, 11: e053248. PMID: 34281933, PMCID: PMC8291313, DOI: 10.1136/bmjopen-2021-053248.Peer-Reviewed Original Research2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference Report
Committee, Benjamin I, Valentine C, Oetgen W, Sheehan K, 1 T, Brindis R, Roach W, Harrington R, Levine G, Redberg R, Broccolo B, Hernandez A, Force T, Douglas P, Piña I, Benjamin E, Coylewright M, Saucedo J, Ferdinand K, Hayes S, Poppas A, 3 T, Furie K, Mehta L, Erwin J, Mieres J, Murphy D, Weissman G, West C, 4 T, Lawrence W, Masoudi F, Jones C, Matlock D, Miller J, Spertus J, Todman L, 5 T, Biga C, Chazal R, Creager M, Fry E, Mack M, Yancy C, Anderson R. 2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference Report. Journal Of The American College Of Cardiology 2021, 77: 3079-3133. DOI: 10.1016/j.jacc.2021.04.004.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 Letters2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics
Benjamin IJ, Valentine CM, Oetgen WJ, Sheehan KA, Brindis RG, Roach WH, Harrington RA, Levine GN, Redberg RF, Broccolo BM, Hernandez AF, Douglas PS, Piña IL, Benjamin EJ, Coylewright MJ, Saucedo JF, Ferdinand KC, Hayes SN, Poppas A, Furie KL, Mehta LS, Erwin JP, Mieres JH, Murphy DJ, Weissman G, West CP, Lawrence WE, Masoudi FA, Jones CP, Matlock DD, Miller JE, Spertus JA, Todman L, Biga C, Chazal RA, Creager MA, Fry ET, Mack MJ, Yancy CW, Anderson RE. 2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics. Circulation 2021, 143: e1035-e1087. PMID: 33974449, DOI: 10.1161/cir.0000000000000963.Peer-Reviewed Original ResearchReporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatientsEquitable Access to Research Benefits: Considerations for COVID-19 Vaccine Development and Clinical Trial Crossover
Zaidi D, Miller J, Varma T, Boatright D, Friesen P. Equitable Access to Research Benefits: Considerations for COVID-19 Vaccine Development and Clinical Trial Crossover. The American Journal Of Bioethics 2021, 21: 86-88. PMID: 33616486, DOI: 10.1080/15265161.2020.1870768.Peer-Reviewed Original ResearchCOVID-19 vaccine research and the trouble with clinical equipoise
Friesen P, Caplan AL, Miller JE. COVID-19 vaccine research and the trouble with clinical equipoise. The Lancet 2021, 397: 576. PMID: 33539728, PMCID: PMC7906638, DOI: 10.1016/s0140-6736(21)00198-7.Peer-Reviewed Original Research