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
Approval of Drugs With Unmet Trial End Points—In Reply
Johnston J, Ross J, Ramachandran R. Approval of Drugs With Unmet Trial End Points—In Reply. JAMA Internal Medicine 2023, 183: 889-890. PMID: 37307009, DOI: 10.1001/jamainternmed.2023.2240.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
2021
Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements
Ramachandran R, Morten CJ, Ross JS. Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements. JAMA 2021, 326: 2131-2132. PMID: 34766971, DOI: 10.1001/jama.2021.19773.Commentaries, Editorials and LettersMeSH KeywordsActivin Receptors, Type IIAntineoplastic AgentsAxitinibCarcinoma, Renal CellClinical Trials as TopicClinical Trials, Phase II as TopicDrug IndustryHumansImmunoglobulin Fc FragmentsKidney NeoplasmsLaw EnforcementMandatory ReportingNational Institutes of Health (U.S.)Recombinant Fusion ProteinsRegistriesUnited StatesUnited States Food and Drug AdministrationImplementation 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
2016
Generic Drug Approvals Since the 1984 Hatch-Waxman Act
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Internal Medicine 2016, 176: 1391-3. PMID: 27428055, DOI: 10.1001/jamainternmed.2016.3411.Peer-Reviewed Original Research
2015
Would a Breakthrough Therapy by Any Other Name Be as Promising?
Ross JS, Redberg RF. Would a Breakthrough Therapy by Any Other Name Be as Promising? JAMA Internal Medicine 2015, 175: 1858-1859. PMID: 26390064, DOI: 10.1001/jamainternmed.2015.5311.Commentaries, Editorials and Letters