2009
The changing face of Phase 1 cancer clinical trials
Craft BS, Kurzrock R, Lei X, Herbst R, Lippman S, Fu S, Karp DD. The changing face of Phase 1 cancer clinical trials. Cancer 2009, 115: 1592-1597. PMID: 19165808, PMCID: PMC2668727, DOI: 10.1002/cncr.24171.Peer-Reviewed Original ResearchConceptsPhase 2 trialEarly phase clinical trialsPhase 1 studyPhase 1 trialClinical trialsVital sign determinationsCancer clinical trialsPhysical examinationEarly phase cancer clinical trialsWeeks of protocolPhase 2 studyPhase 1 cancer clinical trialsNew drug studyStudy requirementsPhase 1Pharmacokinetic samplingMore patientsMedical oncologyOncology communityLaboratory testsSuch trialsDrug studiesTrialsPhase 1 programElectrocardiogram
2007
The changing face of phase I protocols: A closer look at study requirements
Craft B, Kurzrock R, Herbst R, Culotta K, Stewart C, Dorsey V, Lippman S, Gingher D, Bekele N, Karp D. The changing face of phase I protocols: A closer look at study requirements. Journal Of Clinical Oncology 2007, 25: 3061-3061. DOI: 10.1200/jco.2007.25.18_suppl.3061.Peer-Reviewed Original ResearchClinical Translational Research CenterPhase II trialPhase I clinical trialPhase I trialII trialClinical trialsPhase II trialMedical oncologyTranslational Research CenterCancer clinical trialsCurrent phase ILate-phase studiesPhase I programSame time periodTherapeutic requirementsECG monitoringTrialsSignificant financial relationshipElectrocardiographyStudy requirementsOncologyStudy complexityI programMore PK