Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement
Borate U, Pugh K, Waller A, Welkie R, Huang Y, Bewersdorf J, Stahl M, DeZern A, Platzbecker U, Sekeres M, Wei A, Buckstein R, Roboz G, Savona M, Loghavi S, Hasserjian R, Fenaux P, Sallman D, Hourigan C, Della Porta M, Nimer S, Little R, Santini V, Efficace F, Taylor J, Garcia-Manero G, Odenike O, Kim T, Halene S, Komrokji R, Griffiths E, Greenberg P, Xu M, Xie Z, Bejar R, Sanz G, Patnaik M, Figueroa M, Carraway H, Abdel-Wahab O, Starczynowski D, Padron E, Boultwood J, Gore S, Daver N, Churpek J, Majeti R, Bennett J, List A, Brunner A, Zeidan A. Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement. Blood 2024, 145: 1369-1381. PMID: 40146152, PMCID: PMC11969261, DOI: 10.1182/blood.2023023717.Peer-Reviewed Original ResearchConceptsBarriers to clinical trial enrollmentPhase 3 trialClinical trial eligibilityClinical trial enrollmentClinical trialsEligibility criteriaTrial eligibilitySafety signalsTrial enrollmentExclusion criteriaEarly-phase trialsReal-world populationPhase of trialPatientsDrug safety signalsPosition statementAnalyzing determinants of premature trial discontinuation in leukemia clinical trials
Rotter L, Alhajahjeh A, Stempel J, Grimshaw A, Bewersdorf J, Blaha O, Kewan T, Podoltsev N, Shallis R, Mendez L, Stahl M, Zeidan A. Analyzing determinants of premature trial discontinuation in leukemia clinical trials. Leukemia & Lymphoma 2024, 66: 289-297. PMID: 39440622, DOI: 10.1080/10428194.2024.2416565.Peer-Reviewed Original ResearchClinical trialsSlow accrualLeukemia trialsEarly-phase trialsNon-randomized trialsAcademic-sponsored trialsImprove patient outcomesLeukemia clinical trialsSingle-centerTrial discontinuationSponsored trialsSmall trialsLeukemiaEarly terminationPatient outcomesLate-phaseIndependent reviewersTermination ratesComprehensive searchTrialsA framework for translating tauopathy therapeutics: Drug discovery to clinical trials
Feldman H, Cummings J, Boxer A, Staffaroni A, Knopman D, Rizzo S, Territo P, Arnold S, Ballard C, Beher D, Boeve B, Dacks P, Diaz K, Ewen C, Fiske B, Gonzalez M, Harris G, Hoffman B, Martinez T, McDade E, Nisenbaum L, Palma J, Quintana M, Rabinovici G, Rohrer J, Rosen H, Troyer M, Kim D, Tanzi R, Zetterberg H, Ziogas N, May P, Rommel A. A framework for translating tauopathy therapeutics: Drug discovery to clinical trials. Alzheimer's & Dementia 2024, 20: 8129-8152. PMID: 39316411, PMCID: PMC11567863, DOI: 10.1002/alz.14250.Peer-Reviewed Original ResearchPrimary tauopathiesClinically heterogeneous neurodegenerative diseasesTau protein aggregationHeterogeneous neurodegenerative diseaseSurrogate disease biomarkersTauopathiesProtein aggregationDefinition of rare diseasesAlzheimer's diseaseNeurodegenerative diseasesClinical trialsEarly-phase clinical trialsEarly-phase trialsDisease biomarkersFrontotemporal degenerationDrug developmentProgressive supranuclear palsyDiscovery to clinical trialsSelection of targetsTherapeuticsPharmacodynamic biomarkersPACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer
Barlesi F, Cho B, Goldberg S, Yoh K, Gelatti A, Mann H, Gopinathan A, Bielecka Z, Newton M, Aggarwal C. PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer. Future Oncology 2024, 20: 2137-2147. PMID: 39023287, PMCID: PMC11508940, DOI: 10.1080/14796694.2024.2354160.Peer-Reviewed Original ResearchNon-small-cell lung cancerStage III non-small-cell lung cancerIII non-small-cell lung cancerPhase III trialsConcurrent chemoradiotherapyUnresectable stage III non-small-cell lung cancerLung cancerPhase III PACIFIC trialGlobal standard of careTargeting PD-L1Early-phase trialsStandard of carePACIFIC trialPD-L1Double-blindIII trialsPlacebo-ControlledDurvalumabMonalizumabOleclumabDisease progressionAntitumor activityMonoclonal antibodiesImmunotherapyMAb
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