2020
Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center
Hong D, Marcelo-Lewis K, LoRusso P. Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center. 2020, 71-83. DOI: 10.1007/978-3-030-47682-3_4.Peer-Reviewed Original Research
2009
Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan
Vishnu P, Jasti P, Ding L, Heilbrun L, Venkatramanamoorthy R, LoRusso P, Heath E. Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan. Journal Of Clinical Oncology 2009, 27: e20626-e20626. DOI: 10.1200/jco.2009.27.15_suppl.e20626.Peer-Reviewed Original ResearchKarmanos Cancer InstitutePhase 1 clinical trialOverall survivalClinical trialsPhase ICommon grade 3Median overall survivalPerformance status 1Retrospective chart reviewClinical trial participationYears of ageChart reviewElderly patientsElectrolyte abnormalitiesPatient agePatient demographicsPS 0Biologic agentsMedian ageStatus 1Lack of enrollmentRetrospective studyCombination therapyPatient subgroupsStudy criteria
2007
Barriers to phase I clinical trial protocol IRB approval at KCI
Wang D, Heath E, Powell A, Chaperon T, LaGrone F, LoRusso P. Barriers to phase I clinical trial protocol IRB approval at KCI. Journal Of Clinical Oncology 2007, 25: 9080-9080. DOI: 10.1200/jco.2007.25.18_suppl.9080.Peer-Reviewed Original ResearchInstitutional review boardClinical trialsIRB approvalMedian timePhase 1 clinical trialPhase 1 trialPhase 1 protocolPatient accrualAnti-cancer drug developmentStudy designProtocol approvalReview boardFinal approvalPhase IDrug development processSignificant financial relationshipTrialsApproval statusAverage timeHuman subjectsDrug developmentMolecular therapeuticsApprovalInitial review