2024
Qualitative 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 ResearchCOVID-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 Administration
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