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
2021
Clinical 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 Research
2019
Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Miller J, Ross JS, Wilenzick M, Mello MM. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. The BMJ 2019, 366: l4217. PMID: 31292127, PMCID: PMC6614834, DOI: 10.1136/bmj.l4217.Peer-Reviewed Original ResearchConceptsClinical trial dataTrial dataDrug approvalSectional descriptive studyPharmaceutical companiesFDA drug approvalsLarge pharmaceutical companiesClinical trialsDrug levelsNew drug approvalsUS FoodDrug AdministrationNew drug applicationsFDA approvalPatientsNovel drugsDescriptive studyDrug applicationTrialsDrugsExternal investigatorsSharing scoreDrug companiesTrial transparencyStudy measuresPostmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
Wallach JD, Luxkaranayagam AT, Dhruva SS, Miller JE, Ross JS. Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis. BMC Medicine 2019, 17: 117. PMID: 31203816, PMCID: PMC6572730, DOI: 10.1186/s12916-019-1344-3.Peer-Reviewed Original ResearchConceptsNew clinical trialsClinical trialsPostmarketing commitmentFDA approvalPeer-reviewed journalsNovel drugsPharmaceutical companiesCross-sectional analysisRate of completionRates of registrationClinical studiesPublic reporting requirementsFirst approvalTherapeutic evaluationUS FoodDrug AdministrationTrialsNew drugsFDA documentsBiologicsFDADrugsFDA recordsApprovalStatus