John Concato, MD, FACP, MS, MPH
Professor AdjunctDownloadHi-Res Photo
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Appointments
General Internal Medicine
Primary
Additional Titles
Associate Director, Office of Medical Policy, Center for Drug Evaluation & Research, Food and Drug Administration
Contact Info
Appointments
General Internal Medicine
Primary
Additional Titles
Associate Director, Office of Medical Policy, Center for Drug Evaluation & Research, Food and Drug Administration
Contact Info
Appointments
General Internal Medicine
Primary
Additional Titles
Associate Director, Office of Medical Policy, Center for Drug Evaluation & Research, Food and Drug Administration
Contact Info
About
Titles
Professor Adjunct
Positions outside Yale
Associate Director, Office of Medical Policy, Center for Drug Evaluation & Research, Food and Drug Administration
Biography
Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator and research center director at Yale University & the Department of Veterans Affairs, he now develops, coordinates, and implements medical policy programs and strategic initiatives, with a focus on real-world evidence (RWE). These efforts include overseeing RWE guidance development and demonstration projects, as well as engaging external stakeholders and contributing to the review of RWE submissions, in support of the agency’s evaluation of RWE as mandated by the 21st Century Cures Act.
Appointments
General Internal Medicine
Professor AdjunctPrimary
Other Departments & Organizations
Education & Training
- MPH
- Yale University, Public Health (1991)
- Fellow
- Yale University School of Medicine (1991)
- Resident
- New York University School of Medicine (1989)
- MD
- New York University (1985)
- MS
- New York University, Environmental Health (1981)
Research
Overview
Medical Subject Headings (MeSH)
Epidemiology; Internal Medicine; Prognosis; Research Design
ORCID
0000-0003-2846-0503
Research at a Glance
Yale Co-Authors
Frequent collaborators of John Concato's published research.
Publications Timeline
A big-picture view of John Concato's research output by year.
Research Interests
Research topics John Concato is interested in exploring.
Mihaela Aslan, PhD
Theodore Holford, PhD
Mary Tinetti, MD
Nallakkandi Rajeevan, PhD
Patrick G. O'Connor, MD, MPH, MACP
Sidney Tuttle Bogardus, MD
74Publications
15,092Citations
Research Design
Prognosis
Publications
2024
Use of Sensitivity Analyses to Assess Uncontrolled Confounding from Unmeasured Variables in Observational, Active Comparator Pharmacoepidemiologic Studies: A Systematic Review
Latour C, Delgado M, Su I, Wiener C, Acheampong C, Poole C, Edwards J, Quinto K, Stürmer T, Lund J, Li J, Lopez N, Concato J, Funk M. Use of Sensitivity Analyses to Assess Uncontrolled Confounding from Unmeasured Variables in Observational, Active Comparator Pharmacoepidemiologic Studies: A Systematic Review. American Journal Of Epidemiology 2024, kwae234. PMID: 39098826, DOI: 10.1093/aje/kwae234.Peer-Reviewed Original ResearchAltmetricConceptsUncontrolled confoundingEpidemiology journalsResidual confoundingSystematic reviewRobustness of studiesComparative cohort studyActive comparator cohort studyMedical journal articlesCohort studyConfoundingJournal articlesPharmacoepidemiological studiesSensitivity analysisPotential biasAssess robustnessMeasured variablesUnmeasured variablesPotential concernReview articleStudyJournalsVariablesQualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency
Kambere M, Vu H, Kappel D, Oh K, Budashewitz P, Concato J. Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency. Therapeutic Innovation & Regulatory Science 2024, 58: 987-995. PMID: 38913114, PMCID: PMC11335776, DOI: 10.1007/s43441-024-00674-x.Peer-Reviewed Original ResearchConceptsCOVID-19 public health emergencyPublic health emergencyFood and Drug AdministrationTrial participantsHealth emergencyClinical practice guidelinesAnalysis of inquirySafety of trial participantsClinical trialsTrial-related activityPractice guidelinesCOVID-19Industry trade associationsConduction of clinical trialsU.S. Food and Drug AdministrationClinical practiceInterested partiesTrade associationsPartiesMedical productsBackgroundThis reportRelated guidanceParticipantsQualitative methodsDrug AdministrationCorrelates of suicidal behaviors and genetic risk among United States veterans with schizophrenia or bipolar I disorder
Bigdeli T, Barr P, Rajeevan N, Graham D, Li Y, Meyers J, Gorman B, Peterson R, Sayward F, Radhakrishnan K, Natarajan S, Nielsen D, Wilkinson A, Malhotra A, Zhao H, Brophy M, Shi Y, O’Leary T, Gleason T, Przygodzki R, Pyarajan S, Muralidhar S, Gaziano J, Huang G, Concato J, Siever L, DeLisi L, Kimbrel N, Beckham J, Swann A, Kosten T, Fanous A, Aslan M, Harvey P. Correlates of suicidal behaviors and genetic risk among United States veterans with schizophrenia or bipolar I disorder. Molecular Psychiatry 2024, 29: 2399-2407. PMID: 38491344, DOI: 10.1038/s41380-024-02472-1.Peer-Reviewed Original ResearchCitationsAltmetricConceptsBipolar I disorderSuicidal behaviorElectronic health recordsPolygenic scoresVeterans Health AdministrationSelf-reported SBColumbia-Suicide Severity Rating ScaleBipolar I disorder patientsCorrelates of suicidal behaviorClasses of psychotropic medicationsSelf-injurious behaviorHealth recordsSeverity Rating ScaleDiagnosed mental illnessAssociated with clinical variablesElectronic health record codesEHR domainDepressive disorderC-SSRSLifetime diagnosisSubstance-relatedPsychotropic medicationsSuicidal ideationExternalizing behaviorsSuicide attemptsClinical Interviewing: An Essential but Neglected Method of Medicine
Fava G, Sonino N, Aron D, Balon R, Montiel C, Cao J, Concato J, Eory A, Horwitz R, Rafanelli C, Schnyder U, Wang H, Wise T, Wright J, Zipfel S, Patierno C. Clinical Interviewing: An Essential but Neglected Method of Medicine. Psychotherapy And Psychosomatics 2024, 93: 94-99. PMID: 38382481, DOI: 10.1159/000536490.Peer-Reviewed Original ResearchCitationsConceptsClinical interviewIncrease patient motivationHealthy behaviorsMethods of medicineSelf-managementClinical encountersPatient motivationClinical processesPatient informationQuality of interviewsEducational trainingLack cost effectivenessClinical domainsPresenting complaintMedical historyInterviewsPhysiciansLife settingsTime pressureQuality of dataPersonal attitudesPatientsCost-effectiveExpensive testsDecision making
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 ResearchCitationsAltmetricConceptsReal-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 dataMetformin prescription for U.S. veterans with prediabetes, 2010–2019
Gulanski B, Goulet J, Radhakrishnan K, Ko J, Li Y, Rajeevan N, Lee K, Heberer K, Lynch J, Streja E, Mutalik P, Cheung K, Concato J, Shih M, Lee J, Aslan M. Metformin prescription for U.S. veterans with prediabetes, 2010–2019. Journal Of Investigative Medicine 2023, 72: 139-150. PMID: 37668313, DOI: 10.1177/10815589231201141.Peer-Reviewed Original ResearchMeSH Keywords and ConceptsConceptsBody mass indexVeterans Health AdministrationIncident prediabetesHigh riskHealth AdministrationRetrospective observational cohort studyType 2 diabetes mellitusUse of metforminObservational cohort studyProportion of veteransMetformin prescribingGestational diabetesCohort studyMetformin prescriptionDiabetes mellitusDiabetes preventionMass indexCardiovascular diseaseMultivariable modelPrediabetesSubset of individualsMetforminU.S. veteransHealthcare systemVeteransDecisions 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 ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsBreakthrough 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 programStatusReal-World Evidence for Neonatal Drug Development: Challenges and Opportunities
Singh K, Concato J, Davis J. Real-World Evidence for Neonatal Drug Development: Challenges and Opportunities. The Journal Of Pediatrics 2023, 265: 113806. PMID: 37918517, DOI: 10.1016/j.jpeds.2023.113806.Peer-Reviewed Original ResearchCitationsAltmetricWhen can real‐world data generate real‐world evidence?
Rahman M, Dal Pan G, Stein P, Levenson M, Kraus S, Chakravarty A, Rivera D, Forshee R, Concato J. When can real‐world data generate real‐world evidence? Pharmacoepidemiology And Drug Safety 2023, 33: e5715. PMID: 37855046, DOI: 10.1002/pds.5715.Peer-Reviewed Original ResearchCitationsAltmetricGenome-wide association studies and cross-population meta-analyses investigating short and long sleep duration
Austin-Zimmerman I, Levey D, Giannakopoulou O, Deak J, Galimberti M, Adhikari K, Zhou H, Denaxas S, Irizar H, Kuchenbaecker K, McQuillin A, Concato J, Buysse D, Gaziano J, Gottlieb D, Polimanti R, Stein M, Bramon E, Gelernter J. Genome-wide association studies and cross-population meta-analyses investigating short and long sleep duration. Nature Communications 2023, 14: 6059. PMID: 37770476, PMCID: PMC10539313, DOI: 10.1038/s41467-023-41249-y.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsAssociation studiesGenome-wide association studiesGenetic correlationsWide association studyLinkage disequilibrium scorePositive genetic correlationSleep traitsIndependent lociMillion Veteran ProgramTraitsAncestryUK BiobankVeteran ProgramMendelian randomisationLociHeritabilitySNPsPhenotypeEast AsiansSimilar patternCardiometabolic phenotypes
News
News
- August 08, 2016
Million Veterans Program now world's largest genomic biobank
- May 08, 2015
Building a biobank … a million veterans at a time
- September 15, 2009
Markers for prostate cancer
- May 04, 2009
Molecular Markers May Help Physicians Predict Severity of Prostate Cancer
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