2018
The 21st Century Cures Act and electronic health records one year later: will patients see the benefits?
Lye CT, Forman HP, Daniel JG, Krumholz HM. The 21st Century Cures Act and electronic health records one year later: will patients see the benefits? Journal Of The American Medical Informatics Association 2018, 25: 1218-1220. PMID: 30184156, PMCID: PMC7646899, DOI: 10.1093/jamia/ocy065.Peer-Reviewed Original ResearchConceptsElectronic health recordsHealth recordsHealth information technologyInformation exchange networkHealth information exchangeData sharingHealth information exchange networkInformation technologyCentury Cures ActInformation exchangeInteroperabilityHealth dataCures ActImplementationAccessResearch initiativesRequirementsExchange networksSharingCertification requirementsNetworkTechnologyPotential benefitsRules
2017
Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewers
2015
Characterizing the US FDA's approach to promoting transformative innovation
Downing NS, Krumholz HM, Ross JS, Shah ND. Characterizing the US FDA's approach to promoting transformative innovation. Nature Reviews Drug Discovery 2015, 14: 740-741. PMID: 26435528, DOI: 10.1038/nrd4734.Peer-Reviewed Original Research
2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority
2004
Cancer Trial Enrollment After State-Mandated Reimbursement
Gross CP, Murthy V, Li Y, Kaluzny AD, Krumholz HM. Cancer Trial Enrollment After State-Mandated Reimbursement. Journal Of The National Cancer Institute 2004, 96: 1063-1069. PMID: 15265967, DOI: 10.1093/jnci/djh193.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicColorectal NeoplasmsFemaleGovernment RegulationHumansIncidenceLogistic ModelsLongitudinal StudiesLung NeoplasmsMaleMulticenter Studies as TopicNational Institutes of Health (U.S.)NeoplasmsPatient SelectionPoisson DistributionProstatic NeoplasmsReimbursement MechanismsRetrospective StudiesState GovernmentUnited StatesConceptsCancer trial enrollmentTrial enrollment ratesTrial enrollmentMultivariable analysisTrial participationOdds ratioTrial participantsCoverage policiesCancer trial participantsCooperative group trialsClinical trial enrollmentEarly phase trialsRecruitment of patientsCancer trial participationMedical care costsPhase II trial participantsCancer patientsPhase trialsCancer research studiesGroup trialsCare costsPoisson regressionCancer typesReimbursement policiesPhase II