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 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
2022
Diversity 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
2015
Gatekeepers for pragmatic clinical trials
Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clinical Trials 2015, 12: 442-448. PMID: 26374683, PMCID: PMC4592478, DOI: 10.1177/1740774515597699.Peer-Reviewed Original ResearchThe ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials
Welch MJ, Lally R, Miller JE, Pittman S, Brodsky L, Caplan AL, Uhlenbrauck G, Louzao DM, Fischer JH, Wilfond B. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clinical Trials 2015, 12: 503-510. PMID: 26374681, PMCID: PMC4662375, DOI: 10.1177/1740774515597701.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsClinical trialsPregnant womenVulnerable populationsClinical trial settingsMental disabilitiesPhysical handicapTraditional clinical trialsDisadvantaged personsVulnerable subjectsTrial settingsHealth interventionsClinical settingClinical researchTrialsNeonatesFetusesWomenSubjectsDisabilityChildrenVulnerable research subjectsPopulationSpecific recommendationsPersons