2022
A comprehensive review and characterization of nasopharyngeal carcinoma clinical trials
Xu K, De Ravin E, Suresh N, Brody R, Rajasekaran K. A comprehensive review and characterization of nasopharyngeal carcinoma clinical trials. World Journal Of Otorhinolaryngology - Head And Neck Surgery 2022, 9: 174-182. PMID: 37383331, PMCID: PMC10296046, DOI: 10.1002/wjo2.80.Peer-Reviewed Original ResearchPrimary nasopharyngeal carcinomaNasopharyngeal carcinomaClinical trialsSide effectsPD-1 monoclonal antibodyOptimal therapeutic regimensManagement of recurrentPremature study terminationRecent clinical trialsPhase IV trialRetrospective database studyStandard of careNumerous side effectsPercent of trialsNPC trialsMetastatic diseaseNovel immunotherapiesPatient accrualRelapse rateRecurrent cancerRetrospective reviewStudy terminationFuture trialsTherapeutic regimensClinical effectivenessOncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study
Bakouny Z, Labaki C, Bhalla S, Schmidt A, Steinharter J, Cocco J, Tremblay D, Awad M, Kessler A, Haddad R, Evans M, Busser F, Wotman M, Curran C, Zimmerman B, Bouchard G, Jun T, Nuzzo P, Qin Q, Hirsch L, Feld J, Kelleher K, Seidman D, Huang H, Anderson-Keightly H, Zarif T, Alaiwi S, Champagne C, Rosenbloom T, Stewart P, Johnson B, Trinh Q, Tolaney S, Galsky M, Choueiri T, Doroshow D. Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study. Annals Of Oncology 2022, 33: 836-844. PMID: 35715285, PMCID: PMC9197329, DOI: 10.1016/j.annonc.2022.04.071.Peer-Reviewed Original ResearchConceptsTherapeutic clinical trialsClinical trialsPatient accrualCancer Outcomes StudyNon-white patientsOncological clinical trialsLarge academic centerEarly pandemic periodClinical trial activityCOVID-19Clinical trial conductMulticenter studyNew patientsOncological trialsDirect infectionOutcome studiesPatientsAcademic centersTrial activationTrial conductNormal levelsCohortProgressive recoveryTrialsRacial disparities
2019
United States Intergroup E1609: A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon-α2b for resected high-risk melanoma.
Tarhini A, Lee S, Hodi F, Rao U, Cohen G, Hamid O, Hutchins L, Sosman J, Kluger H, Sondak V, Koon H, Lawrence D, Kendra K, Minor D, Lee C, Albertini M, Flaherty L, Petrella T, Kirkwood J. United States Intergroup E1609: A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon-α2b for resected high-risk melanoma. Journal Of Clinical Oncology 2019, 37: 9504-9504. DOI: 10.1200/jco.2019.37.15_suppl.9504.Peer-Reviewed Original ResearchRelapse-free survivalHigh-risk melanomaOverall survivalAdjuvant therapyAdverse events grade 3High-dose interferon-α2bPhase III adjuvant trialActive control regimenMelanoma adjuvant therapySystemic adjuvant therapySignificant OS differenceCo-primary endpointsAdjuvant ipilimumabAdjuvant standardRFS benefitsAdjuvant trialsTreatment discontinuationData cutoffPrimary endpointITT analysisPatient accrualControl regimenProtocol criteriaGrade 3OS difference
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
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply