2023
Therapeutic 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 ResearchMeSH KeywordsAntineoplastic AgentsCohort StudiesDrug ApprovalEuropeHumansNeoplasmsPharmaceutical PreparationsRetrospective StudiesUnited StatesUnited States Food and Drug AdministrationConceptsEuropean Medicines AgencyRetrospective cohort studyCohort studyTherapeutic valueSupplemental indicationsIndication approvalsHigh therapeutic valueAvailable treatmentsDrug AdministrationUS FoodMedicines AgencyFDA approvalHealth authoritiesCancer disordersSimilar findingsTherapeutic ratingFirst indicationDrugsIndicationsApprovalFDAPatientsLarge subsetProportionPhysiciansExtending the US Food and Drug Administration’s Postmarket Authorities
Lynch H, Sachs R, Lee S, Herder M, Ross J, Ramachandran R. Extending the US Food and Drug Administration’s Postmarket Authorities. JAMA Health Forum 2023, 4: e231313. PMID: 37294583, DOI: 10.1001/jamahealthforum.2023.1313.Commentaries, Editorials and LettersDrug ApprovalFoodHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationUS Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Ross J, Ramachandran R. US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2023, 6: e2318889. PMID: 37358857, PMCID: PMC10293905, DOI: 10.1001/jamanetworkopen.2023.18889.Peer-Reviewed Original ResearchMeSH KeywordsBiological FactorsBiological ProductsDrug ApprovalHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationUS Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021
Johnston J, Ross J, Ramachandran R. US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. JAMA Internal Medicine 2023, 183: 376-380. PMID: 36780148, PMCID: PMC9926353, DOI: 10.1001/jamainternmed.2022.6444.Peer-Reviewed Original ResearchMeSH KeywordsDrug ApprovalHumansPharmaceutical PreparationsResearch DesignUnited StatesUnited States Food and Drug Administration
2022
Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Skydel JJ, Egilman AC, Wallach JD, Ramachandran R, Gupta R, Ross JS. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. JAMA Health Forum 2022, 3: e221158. PMID: 35977252, PMCID: PMC9142876, DOI: 10.1001/jamahealthforum.2022.1158.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersCross-Sectional StudiesDrug ApprovalMedicaidMedicarePharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationConceptsSurrogate end pointsCross-sectional studyClinical benefitConfirmation of benefitEnd pointOriginal indicationClinical outcomesUS FoodConfirmatory trialsMedicaid ServicesPrimary end pointUnproven clinical benefitsTrial end pointsClinical trial resultsTypes of drugsPostapproval trialsAccelerated approvalClinical trialsMAIN OUTCOMEDrug AdministrationMedicare Part BStandard approvalConversion statusSupplemental indicationsTrial results
2021
Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs
Miller JE, Mello MM, Wallach JD, Gudbranson EM, Bohlig B, Ross JS, Gross CP, Bach PB. Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs. JAMA Network Open 2021, 4: e217075. PMID: 33950209, PMCID: PMC8100865, DOI: 10.1001/jamanetworkopen.2021.7075.Peer-Reviewed Original ResearchMeSH KeywordsAfricaClinical Trials as TopicCross-Sectional StudiesDeveloped CountriesDeveloping CountriesDrug ApprovalDrug CostsHumansMarketingPharmaceutical PreparationsUnited StatesConceptsFDA approvalHigh-income countriesDrug approvalIncome countriesNovel drugsDrug Administration (FDA) drug approvalsRegulatory agency websitesCross-sectional analysisProportion of drugPrimary outcomeFDA drug approvalsProportion of countriesDrug trialsMAIN OUTCOMEUS FoodClinical researchCountry income levelLow-income countriesMarketing approvalTrialsGoogle ScholarDrugsDrug companiesApprovalMedian
2020
Reporting of substance use treatment quality in United States adult drug courts
Joudrey PJ, Howell BA, Nyhan K, Moravej A, Doernberg M, Ross JS, Wang EA. Reporting of substance use treatment quality in United States adult drug courts. International Journal Of Drug Policy 2020, 90: 103050. PMID: 33310636, PMCID: PMC8046712, DOI: 10.1016/j.drugpo.2020.103050.Peer-Reviewed Original ResearchMeSH KeywordsAdultCriminal LawHumansPharmaceutical PreparationsRecidivismReproducibility of ResultsSubstance-Related DisordersUnited StatesConceptsService utilizationTreatment qualityTreatment quality measuresProcess evaluationRelated health outcomesSubstance use treatmentGrey literature searchSystematic grey literature searchMeasures of substanceTreatment outcomesHealth outcomesLiterature searchUse treatmentDrug courtsProcess measuresLow uptakePractice informationOutcomesDrug court programProgram graduationAdult drug courtsOn-Label and Off-Label Clinical Studies of FDA–Approved Ophthalmic Therapeutics
Gopal AD, Wallach JD, Shah SA, Regillo C, Ross JS. On-Label and Off-Label Clinical Studies of FDA–Approved Ophthalmic Therapeutics. Ophthalmology 2020, 128: 332-334. PMID: 32682839, PMCID: PMC9900733, DOI: 10.1016/j.ophtha.2020.07.028.Peer-Reviewed Original ResearchDisagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015
MacGregor A, Zhang AD, Wallach JD, Ross JS, Herder M. Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015. JAMA Network Open 2020, 3: e209498. PMID: 32706379, PMCID: PMC7382003, DOI: 10.1001/jamanetworkopen.2020.9498.Peer-Reviewed Original ResearchAssessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open 2020, 3: e203284. PMID: 32315070, PMCID: PMC7175081, DOI: 10.1001/jamanetworkopen.2020.3284.Peer-Reviewed Original ResearchMeSH KeywordsBiological ProductsClinical Trials as TopicCross-Sectional StudiesDrug ApprovalHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationConceptsPivotal trialsProportion of indicationsIndication approvalsNew drugsUS FoodTrial durationPrimary end pointTherapeutic areasPivotal efficacy trialsCross-sectional studyDrug Administration approvalFast track designationCommon therapeutic areasRecent FDA approvalOrphan designationLonger trial durationAccelerated approvalAdministration approvalClinical trialsMonths durationEfficacy trialsMAIN OUTCOMETherapeutic safetyDrug AdministrationFDA approval
2018
Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonths
2017
The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. Journal Of Managed Care & Specialty Pharmacy 2017, 23: 1066-1076. PMID: 28944731, PMCID: PMC10397719, DOI: 10.18553/jmcp.2017.23.10.1066.Peer-Reviewed Original ResearchMeSH KeywordsCommerceDrug ApprovalDrug IndustryHumansPharmaceutical PreparationsPrescription DrugsTherapeutic EquivalencyUnited StatesUnited States Food and Drug AdministrationConceptsUnapproved Drugs InitiativeClinical evidenceAverage wholesale priceFDA approvalPrescription drugsNew clinical trial evidenceMedian shortage durationClinical trial evidenceNew clinical evidenceDrug shortagesNumber of drugsEvidence of safetyUtah Drug Information ServiceHealth-System Pharmacists
2014
Marketing to Physicians in a Digital World
Manz C, Ross JS, Grande D. Marketing to Physicians in a Digital World. New England Journal Of Medicine 2014, 371: 1857-1859. PMID: 25390738, DOI: 10.1056/nejmp1408974.Commentaries, Editorials and LettersMeSH KeywordsDrug IndustryElectronic Health RecordsHumansInappropriate PrescribingMarketingPharmaceutical PreparationsPhysiciansSocial MediaInconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison
Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS. Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison. PLOS ONE 2014, 9: e109100. PMID: 25333986, PMCID: PMC4204813, DOI: 10.1371/journal.pone.0109100.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCross-Sectional StudiesEuropean UnionHumansInternational AgenciesLegislation, DrugPharmaceutical PreparationsSafety-Based Drug WithdrawalsClinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food
2011
Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing
Korenstein D, Keyhani S, Mendelson A, Ross JS. Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing. PLOS ONE 2011, 6: e23336. PMID: 21858076, PMCID: PMC3157354, DOI: 10.1371/journal.pone.0023336.Peer-Reviewed Original ResearchConceptsSafe prescribingPharmaceutical advertisementsCross-sectional analysisFDA guidelinesAdherence ratesCounter medicationsMedian 2Inclusion criteriaDisease awarenessCurrent FDA guidelinesDrug AdministrationPrescribingPharmaceutical advertisingSerious riskUnique advertisementsAdherenceDrug namesPublic healthStudy limitationsEfficacy informationGuideline itemsMedical journalsGuidelinesFDARisk