2023
Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making
Yuan L, Rahman M, Concato J. Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making. Clinical And Translational Science 2023, 17: e13702. PMID: 38093484, PMCID: PMC10766019, DOI: 10.1111/cts.13702.Peer-Reviewed Original ResearchReal-world evidenceEuropean Medicines AgencyDrug approvalOpen-label extension studyNon-interventional studySingle-arm trialClinical trial implementationUnited States FoodInterventional trialsComparator armDrug AdministrationMedicines AgencyExtension studyStudy designUse of RWEStates FoodPharmacovigilance activitiesTrialsRegulatory agenciesApprovalLack of agreementTrial implementationLiterature reviewTherapeutic contextReal-world dataDecisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
Poddar A, Raggio M, Concato J. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019. Therapeutic Innovation & Regulatory Science 2023, 58: 214-221. PMID: 37926768, PMCID: PMC10764372, DOI: 10.1007/s43441-023-00589-z.Peer-Reviewed Original ResearchConceptsBreakthrough therapy statusTherapy statusInsufficient treatment effectNon-oncology drugsReview of requestsUnmet medical needInadequate study designBreakthrough therapy designationConclusionsThis analysisCommon reasonInvestigational drugsUS FoodMedical needOrphan diseaseStudy designDrug evaluationMarketing approvalCorresponding drugsDrugsApproval statusTreatment effectsDrug developmentFDA processDesignation programStatus
2015
Million Veteran Program: A mega-biobank to study genetic influences on health and disease
Gaziano JM, Concato J, Brophy M, Fiore L, Pyarajan S, Breeling J, Whitbourne S, Deen J, Shannon C, Humphries D, Guarino P, Aslan M, Anderson D, LaFleur R, Hammond T, Schaa K, Moser J, Huang G, Muralidhar S, Przygodzki R, O'Leary TJ. Million Veteran Program: A mega-biobank to study genetic influences on health and disease. Journal Of Clinical Epidemiology 2015, 70: 214-223. PMID: 26441289, DOI: 10.1016/j.jclinepi.2015.09.016.Peer-Reviewed Original ResearchConceptsMillion Veteran ProgramVeterans Affairs Health Care SystemObservational cohort studyVA electronic health recordVeteran ProgramHealth care deliverySelf-reported raceHealth care systemElectronic health recordsCohort studyAfrican American populationBlood samplesPeer-reviewed research studiesCare deliveryClinical decisionGenetic testingStudy designRecruiting sitesCare systemHealth recordsMost participantsPrecision medicineGenetic influencesAmerican populationParticipants
2013
Study Design and “Evidence” in Patient-oriented Research
Concato J. Study Design and “Evidence” in Patient-oriented Research. American Journal Of Respiratory And Critical Care Medicine 2013, 187: 1167-1172. PMID: 23725613, DOI: 10.1164/rccm.201303-0521oe.Peer-Reviewed Original ResearchConceptsRandomized trialsObservational studyPatient-oriented researchStudy designCritical care literatureEvidence-based medicineGeneral medicalCause-effect associationClinical careGold standard statusComparative effectivenessEvidence baseTrialsCare literatureIndividual studiesPatientsStudy resultsResearch designStudyMethodological designCareEvidence approachDesign of “Neuropsychological and Mental Health Outcomes of Operation Iraqi Freedom: A Longitudinal Cohort Study”
Aslan M, Concato J, Peduzzi P, Proctor S, Schnurr P, Marx B, McFall M, Gleason T, Huang G, Vasterling J. Design of “Neuropsychological and Mental Health Outcomes of Operation Iraqi Freedom: A Longitudinal Cohort Study”. Journal Of Investigative Medicine 2013, 61: 569. DOI: 10.231/jim.0b013e31828407ff.Peer-Reviewed Original ResearchNeurocognition Deployment Health StudyPosttraumatic stress disorderOperation Iraqi FreedomStudy designVA Cooperative Studies ProgramSubsequent posttraumatic stress disorderLongitudinal cohort studyStatistical analysis planTraumatic brain injuryMental health disordersTarget sample sizeCooperative Studies ProgramIraqi FreedomTiming of assessmentMental health outcomesCurrent study dataUS Army soldiersCohort studyBrain injuryStudy populationHealth StudyPostdeployment assessmentsHealth disordersNeuropsychological changesHealth outcomes
2010
Observational Methods in Comparative Effectiveness Research
Concato J, Lawler EV, Lew RA, Gaziano JM, Aslan M, Huang GD. Observational Methods in Comparative Effectiveness Research. The American Journal Of Medicine 2010, 123: e16-e23. PMID: 21184862, DOI: 10.1016/j.amjmed.2010.10.004.Peer-Reviewed Original ResearchConceptsComparative effectiveness researchObservational studyGroup of patientsVeterans Health AdministrationEffectiveness researchSpecific medical conditionsPatient-oriented researchCorresponding study designPatient populationTreatment optionsMedical conditionsHealth AdministrationStudy designMedical ailmentsIndividual studiesAvailable optionsPatientsRCTsOptionsProminent featureStudyAdministrationTrialsComparative Effectiveness Research
Concato J, Peduzzi P, Huang G, O'Leary T, Kupersmith J. Comparative Effectiveness Research. Journal Of Investigative Medicine 2010, 58: 764. DOI: 10.2310/jim.0b013e3181e3d2af.Peer-Reviewed Original ResearchComparative effectiveness researchVA electronic medical record systemProton pump inhibitor medicationVeterans AffairsBenefits of clopidogrelOptimal medical therapyAcute coronary syndromeCoronary artery bypassDifferent therapeutic optionsPercutaneous coronary interventionEffectiveness researchElectronic medical record systemPatient-oriented researchVA trialArtery bypassCoronary syndromeCoronary interventionMedical record systemInhibitor medicationMedical therapyTherapeutic optionsClinical trialsObservational studyHealth outcomesStudy design