2024
Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.Peer-Reviewed Original Research
2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original ResearchTherapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
Vokinger K, Glaus C, Kesselheim A, Serra-Burriel M, Ross J, Hwang T. Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study. The BMJ 2023, 382: e074166. PMID: 37407074, PMCID: PMC10320829, DOI: 10.1136/bmj-2022-074166.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyCohort studyTherapeutic valueSupplemental indicationsIndication approvalsHigh therapeutic valueAvailable treatmentsDrug AdministrationUS FoodMedicines AgencyFDA approvalHealth authoritiesCancer disordersSimilar findingsTherapeutic ratingFirst indicationDrugsIndicationsApprovalFDAPatientsLarge subsetProportionPhysicians
2022
Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance
Xiao R, Ross JS, Gross CP, Dusetzina SB, McWilliams JM, Sethi RKV, Rathi VK. Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. JAMA Internal Medicine 2022, 182: 603-611. PMID: 35435948, PMCID: PMC9016607, DOI: 10.1001/jamainternmed.2022.1022.Peer-Reviewed Original ResearchConceptsCancer CenterCancer therapyCross-sectional studyHospital acquisition costNational Cancer InstituteCross-sectional analysisPrimary outcomeSecondary outcomesPrivate health insuranceMAIN OUTCOMEClinical careCancer InstituteMedicare Part B spendingTherapyAcquisition costsPart B spendingHospitalCancer treatmentHealth insuranceFinancial burdenB spendingPatientsSame centerOutcomesPayersAccess to High-Volume Hospitals for High-Risk Cancer Surgery for Racial and Ethnic Minoritized Groups
Salazar MC, Canavan ME, Holaday LW, Billingsley KG, Ross J, Boffa DJ, Gross CP. Access to High-Volume Hospitals for High-Risk Cancer Surgery for Racial and Ethnic Minoritized Groups. JNCI Cancer Spectrum 2022, 6: pkac024. PMID: 35603855, PMCID: PMC8997114, DOI: 10.1093/jncics/pkac024.Peer-Reviewed Original ResearchConceptsHigh-risk cancer surgeryHigh-volume hospitalsCancer surgeryHispanic patientsNational Cancer DatabaseNon-Hispanic patientsNon-black patientsLung resectionBlack patientsCancer DatabaseBetter outcomesPatientsSurgeryHospitalPancreatectomyLow probabilityInequitable accessEsophagectomyProctectomyResection
2021
Implementation of 21st Century Cures Act Expanded Access Policies Requirements
Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clinical Pharmacology & Therapeutics 2021, 110: 1579-1584. PMID: 34431083, DOI: 10.1002/cpt.2401.Peer-Reviewed Original ResearchReporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatients
2017
Post‐marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross‐sectional study
Zeitoun J, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post‐marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross‐sectional study. International Journal Of Cancer 2017, 142: 414-423. PMID: 28929484, DOI: 10.1002/ijc.31061.Peer-Reviewed Original ResearchConceptsPost-marketing trialsPrimary outcomeNovel anticancer agentsPost-market researchAnticancer agentsSupplemental indicationsCross-sectional studyPost-marketing researchEuropean Medicines AgencyCross-sectional analysisTypes of cancerPost-market trialClinical endpointsHematologic malignanciesKidney cancerSolid cancersSurrogate endpointsUS FoodDrug AdministrationMedicines AgencyOverall populationCancerTrialsPublication rateOutcomes