2018
Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis
Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. The BMJ 2018, 361: k2031. PMID: 29794072, PMCID: PMC5967364, DOI: 10.1136/bmj.k2031.Peer-Reviewed Original ResearchConceptsProspective cohort studyCohort studyClinical trialsPostmarketing requirementsTimeliness of registrationNew drugsUS FoodDrug AdministrationFDA approvalStudy designNumber of patientsSectional analysisPostmarket studiesFirst approvalRegistrySecondary analysisTrialsBiologicsDrugsComparator typeAdministrationApprovalFDAFDA's authority
2016
Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study
Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. The BMJ 2016, 354: i4189. PMID: 27540015, PMCID: PMC4989280, DOI: 10.1136/bmj.i4189.Peer-Reviewed Original ResearchConceptsHospital referral regionsOral anticoagulantsReferral regionsDiabetes drugsDrug classesGreater prescribingMedicare Part D beneficiariesAdditional daysPart D beneficiariesMedicare Part D prescriptionsCross-sectional analysisSectional ecological studyMedicare Part DPart D prescriptionsManufacturers of pharmaceuticalsPrescribingAnticoagulantsPhysiciansDrugsPart DEducational materialsSectional analysisStudy limitationsConsulting feesAssociationPublication and reporting of clinical trial results: cross sectional analysis across academic medical centers
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. The BMJ 2016, 352: i637. PMID: 26888209, PMCID: PMC4768882, DOI: 10.1136/bmj.i637.Peer-Reviewed Original ResearchConceptsAcademic medical centerInterventional clinical trialsClinical trialsMedical CenterStudy completionPrimary completion dateClinical trial resultsReporting of resultsSectional analysisInterventional trialsProportion of trialsTrial resultsTrialsMonthsPhase IIManual reviewLead investigatorUnited StatesProportionRate of publicationReportingCompletionPatientsCenter
2012
Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis
Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. The BMJ 2012, 344: d7292. PMID: 22214755, PMCID: PMC3623605, DOI: 10.1136/bmj.d7292.Peer-Reviewed Original Research