2024
Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies
Miller J, Pelletiers W, Suttiratana S, Mensah M, Schwartz J, Ramachandran R, Gross C, Ross J. Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies. BMJ Medicine 2024, 3: e000920. PMID: 39175919, PMCID: PMC11340651, DOI: 10.1136/bmjmed-2024-000920.Peer-Reviewed Original ResearchUS Food and Drug AdministrationFood and Drug AdministrationClinical trialsReference standardDrug AdministrationInternational Federation of Pharmaceutical ManufacturersTrial designPhases of clinical trialsEuropean Medicines AgencyEnrollment targetsPharmaceutical company websitesTrial recruitmentPatient populationImprove patient awarenessInternational FederationMedicines AgencyWorld Health OrganizationEligibility criteriaCompany policiesDiversity policiesStakeholder guidanceTrialsFDAPharmaceutical Research and Manufacturers of AmericaCharacteristics of participants
2021
Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis
Axson S, Mello MM, Lincow D, Yang C, Gross C, Ross JS, Miller J. Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ Open 2021, 11: e053248. PMID: 34281933, PMCID: PMC8291313, DOI: 10.1136/bmjopen-2021-053248.Peer-Reviewed Original Research
2019
Utilization and Early Discontinuation of First-Line Ibrutinib for Patients with Chronic Lymphocytic Leukemia Treated in the Community Oncology Setting in the United States
Huntington S, Soulos P, Barr P, Jacobs R, Lansigan F, Odejide O, Schwartzberg L, Davidoff A, Gross C. Utilization and Early Discontinuation of First-Line Ibrutinib for Patients with Chronic Lymphocytic Leukemia Treated in the Community Oncology Setting in the United States. Blood 2019, 134: 797. DOI: 10.1182/blood-2019-122054.Peer-Reviewed Original ResearchFirst-line settingChronic lymphocytic leukemiaFlatiron Health databaseECOG performance statusFirst-line treatmentEarly discontinuationMultivariable logistic regressionPerformance statusIbrutinib discontinuationSpeakers bureauClinical trialsCLL diagnosisCLL therapyLymphocytic leukemiaHealth databasesLogistic regressionBruton tyrosine kinase inhibitorsFirst-line ibrutinibUse of ibrutinibWorse performance statusPoor performance statusRetrospective cohort studyCommunity oncology settingClinical decision support toolCommunity oncology practices
2017
Adoption of immunotherapy into real-world practice: Insights from the use of checkpoint inhibitors.
O'Connor J, Seidl-Rathkopf K, You P, Nussbaum N, Torres A, Fessele K, Darius K, Adelson K, Yin E, Presley C, Chiang A, Ross J, Abernethy A, Gross C. Adoption of immunotherapy into real-world practice: Insights from the use of checkpoint inhibitors. Journal Of Clinical Oncology 2017, 35: e14583-e14583. DOI: 10.1200/jco.2017.35.15_suppl.e14583.Peer-Reviewed Original ResearchElectronic health record databaseReal-world practiceCheckpoint inhibitorsAdvanced non-small cell lung cancerFDA approvalNon-small cell lung cancerDeath-1 checkpoint inhibitorsMetastatic renal cell carcinomaAdoption of immunotherapyGeneralizability of trialsCell lung cancerRenal cell carcinomaDrug Administration approvalHealth record databaseChi-square testStudy drugOlder patientsSystemic therapyAdvanced melanomaMedian ageTherapy linesCell carcinomaLung cancerAdministration approvalClinical trials
2015
Comparative Effectiveness of Azacitidine Versus Decitabine Among Older Adults Diagnosed with Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Zeidan A, Long J, Hall J, Wang R, Huntington S, Abel G, Prebet T, Podoltsev N, Gross C, Gore S, Ma X, Davidoff A. Comparative Effectiveness of Azacitidine Versus Decitabine Among Older Adults Diagnosed with Higher-Risk Myelodysplastic Syndromes (HR-MDS). Blood 2015, 126: 3285. DOI: 10.1182/blood.v126.23.3285.3285.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeHR-MDS patientsKaplan-Meier survival curvesEnd of studyHMA initiationMedian OSClinical trialsComorbidity countHazard ratioHigh school educationClinical practiceMultivariate Cox proportional hazards modelSurvival curvesEnd Results-Medicare databaseMedian household incomeRandomized phase III trialReal-world clinical practiceCox proportional hazards modelOlder MDS patientsDisability Status ScoreRetrospective cohort studyOverall survival advantagePhase III trialsYear of diagnosisErythropoiesis-stimulating agents
2012
An assessment of the collective efforts of clinical trials to provide evidence-based practice guidelines in cancer care.
Lloyd S, Buscariollo D, Gross C, Makarov D, Yu J. An assessment of the collective efforts of clinical trials to provide evidence-based practice guidelines in cancer care. Journal Of Clinical Oncology 2012, 30: 6019-6019. DOI: 10.1200/jco.2012.30.15_suppl.6019.Peer-Reviewed Original ResearchRCT enrollmentMeasures of burdenCancer research effortsNCCN guidelinesNCCN recommendationsEndometrial cancerNational Comprehensive Cancer Network guidelinesEvidence-based practice guidelinesPhase 3 RCTsClinical trial enrollmentPrevalent solid tumorsTrial enrollmentNetwork guidelinesCancer careCNS cancerTreatment recommendationsClinical trialsProstate cancerPractice guidelinesSolid tumorsLife yearsMultivariate analysisMost recommendationsCancer typesCancer
2011
Are the Efforts of Current Clinical Trials Involving Radiation Therapy Focused on the Evidence Gaps in Cancer Treatment?
Lloyd S, Gross C, Makarov D, Yu J. Are the Efforts of Current Clinical Trials Involving Radiation Therapy Focused on the Evidence Gaps in Cancer Treatment? International Journal Of Radiation Oncology • Biology • Physics 2011, 81: s139-s140. DOI: 10.1016/j.ijrobp.2011.06.286.Peer-Reviewed Original Research
2004
Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities
Murthy VH, Krumholz HM, Gross CP. Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities. JAMA 2004, 291: 2720-2726. PMID: 15187053, DOI: 10.1001/jama.291.22.2720.Peer-Reviewed Original ResearchConceptsCancer trialsCancer clinical trialsClinical trialsTrial participantsEnrollment fractionWhite patientsAge groupsCross-sectional population-based analysisProstate cancer clinical trialsCancer research participationCancer trial participantsColorectal cancer trialsPatients 75 yearsIncident cancer patientsLung cancer trialsPopulation-based analysisRelative risk ratiosAge-based disparitiesYears of ageNational Cancer InstituteLogistic regression modelsLittle recent informationTrial enrolleesYounger patientsPatient group