2023
Considerations for Drug Development in Myelodysplastic Syndromes
Sekeres M, Kim N, DeZern A, Norsworthy K, Garcia J, de Claro R, Theoret M, Jen E, Ehrlich L, Zeidan A, Komrokji R. Considerations for Drug Development in Myelodysplastic Syndromes. Clinical Cancer Research 2023, 29: 2573-2579. PMID: 36688922, PMCID: PMC10349686, DOI: 10.1158/1078-0432.ccr-22-3348.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMyelodysplastic syndromeTrial designDrug developmentResponse criteriaLow-risk diseaseHigh-risk patientsFuture trial designClinical trial designQuality of lifeValidation of PatientHigh-need populationDurable responsesOverall survivalAnemic patientsTransfusion dependencyClinical benefitPatient populationAdvanced ageClinical trialsDose reductionOutcome instrumentsNew therapiesPreclinical modelingPatientsActive drug
2015
Measures of outcome for stimulant trials: ACTTION recommendations and research agenda
Kiluk BD, Carroll KM, Duhig A, Falk DE, Kampman K, Lai S, Litten RZ, McCann DJ, Montoya ID, Preston KL, Skolnick P, Weisner C, Woody G, Chandler R, Detke MJ, Dunn K, Dworkin RH, Fertig J, Gewandter J, Moeller FG, Ramey T, Ryan M, Silverman K, Strain EC. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda. Drug And Alcohol Dependence 2015, 158: 1-7. PMID: 26652899, PMCID: PMC4698050, DOI: 10.1016/j.drugalcdep.2015.11.004.Peer-Reviewed Original ResearchConceptsStimulant use disorderClinical trialsMeaningful outcome measuresUse disordersTreatment successOutcome measuresStimulant abstinenceAddiction Clinical Trial TranslationsFuture clinical trialsClinical trial endpointsClinical trial dataAlcohol use disorderMeasures of outcomeValidation of PatientStimulant trialsTrial endpointsEfficacious pharmacotherapiesUrine testingSustained abstinenceTrial dataSecondary analysisStimulant useTrialsPsychosocial benefitsDisorders
2010
Melanoma: A model for testing new agents in combination therapies
Ascierto PA, Streicher HZ, Sznol M. Melanoma: A model for testing new agents in combination therapies. Journal Of Translational Medicine 2010, 8: 38. PMID: 20406483, PMCID: PMC2873374, DOI: 10.1186/1479-5876-8-38.Peer-Reviewed Original ResearchConceptsC-Kit inhibitorsAdvanced melanomaImmune modulatorsIntroduction of interferonNew single agentsMulti-modality treatmentReliable predictive biomarkersSelection of patientsAdoptive cellular therapyAnti-angiogenesis agentsValidation of PatientAdditional molecular targetsImmunologic modulatorsAdvanced diseaseCombination therapyPredictive biomarkersIL-2High success rateIndividual patientsNew agentsSmall molecule inhibitorsPatientsSingle agentResponse rateAnticancer modalities
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