Featured Publications
Evaluation 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 ResearchMeSH KeywordsAfricaClinical Trials as TopicCross-Sectional StudiesDeveloped CountriesDeveloping CountriesDrug ApprovalDrug CostsHumansMarketingPharmaceutical PreparationsUnited StatesConceptsFDA 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
2023
Ranking 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 ResearchMeSH KeywordsCommerceCOVID-19 Drug TreatmentDrug RepositioningHumansMotivationPharmaceutical PreparationsUnited StatesConceptsData accessIntellectual property challengesDesign decisionsCompound databasesExamples of companiesBusiness reasonsCore approachRoot causeMulti-partner collaborationsText termsFull potentialText reviewBusiness Source CompleteResourcesAccessCollaborationDatabaseSuperiorityMore informationSafety problems
2018
Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonths