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 Administration
2018
Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials
O’Connor J, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Chiang AC, Ross JS, Abernethy AP, Gross CP. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials. JAMA Oncology 2018, 4: e180798-e180798. PMID: 29800974, PMCID: PMC6143052, DOI: 10.1001/jamaoncol.2018.0798.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, Monoclonal, HumanizedCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellClinical Trials as TopicFemaleFollow-Up StudiesHumansKidney NeoplasmsLung NeoplasmsMaleMiddle AgedNivolumabPractice Patterns, Physicians'PrognosisProgrammed Cell Death 1 ReceptorRetrospective StudiesConceptsNon-small cell lung cancerPivotal clinical trialsRenal cell carcinomaCell death 1 proteinEligible patientsImmune checkpoint inhibitorsDeath 1 proteinClinical trialsClinical practiceFDA approvalAgent treatmentCheckpoint inhibitorsAnti-PD-1 agentsFlatiron Health networkRetrospective cohort studyAge of patientsCell lung cancerClinical trial participantsCohort studyPatient ageYounger patientsMore patientsSuch patientsTrial evidenceCell carcinoma