2024
Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable
Yap C, Aiyegbusi O, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck A, Gilbert A, Gnanasakthy A, Greystoke A, Hansen A, Kamudoni P, Kholmanskikh O, King-Kallimanis B, Krumholz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell K, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour L, Weber H, Wilson R, Calvert M, Peipert J. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine 2024, 76: 102838. PMID: 39386161, PMCID: PMC11462221, DOI: 10.1016/j.eclinm.2024.102838.Peer-Reviewed Original ResearchEarly phase trialsPatient-reported outcomesPhase trialsInvestigator-reported adverse eventsEarly phase clinical trialsTolerability assessmentsPhase clinical trialsIntegration of patient-reported outcomesAdverse eventsClinical trialsPatient-centred careDosing decisionsDiverse clinical areasTherapy risksLaboratory assessmentPatientsTrialsPatient advocatesClinical areasOutcomesSafety alertsPharmaceutical representativesVirtual roundtableRisk
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