2023
Transparency of Results Reporting in Cancer Clinical Trials
Kao J, Ross J, Miller J. Transparency of Results Reporting in Cancer Clinical Trials. JAMA Network Open 2023, 6: e2328117. PMID: 37556143, PMCID: PMC10413165, DOI: 10.1001/jamanetworkopen.2023.28117.Peer-Reviewed Original Research
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
2013
How a Clinical Trial Registry Became a Symbol of Misinformation
Miller JE. How a Clinical Trial Registry Became a Symbol of Misinformation. The Hastings Center Report 2013, 43: 11-12. PMID: 24249467, DOI: 10.1002/hast.226.Peer-Reviewed Original ResearchConceptsFirst national registryClinical Trials RegistryOngoing clinical trialsNational Cancer InstitutePublic health goalsNational Cancer ActTrials RegistryOpen trialNational registryClinical trialsCancer InstituteRegistryHealth goalsCancer ActCancer therapyPatientsTrialsPharmaceutical companiesDread diseaseDoctorsTherapyCancerDisease