2024
Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program
Mooghali M, Dhruva S, Ross J, Ramachandran R. Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program. JAMA 2024, 332 PMID: 39535767, PMCID: PMC11561719, DOI: 10.1001/jama.2024.20493.Peer-Reviewed Original ResearchAt-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation?
Kadakia K, Ross J, Ramachandran R. At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation? JAMA Internal Medicine 2024, 184: 1153-1155. PMID: 39133501, DOI: 10.1001/jamainternmed.2024.2883.Peer-Reviewed Original ResearchTemporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021
Chaudhry N, Zhang A, Schwartz J, Ramachandran R, Ross J. Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021. JAMA Network Open 2024, 7: e2436789. PMID: 39352702, PMCID: PMC11445682, DOI: 10.1001/jamanetworkopen.2024.36789.Peer-Reviewed Original ResearchFeasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study
Janda G, Jeffery M, Ramachandran R, Ross J, Wallach J. Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study. BMC Medical Research Methodology 2024, 24: 187. PMID: 39198727, PMCID: PMC11351457, DOI: 10.1186/s12874-024-02307-1.Peer-Reviewed Original ResearchConceptsElectronic health record dataElectronic health recordsSubstance use disordersCross-sectional studyAdministrative claimsEligibility criteriaTrials evaluating treatmentPublic health systemClinical trialsIntroductionReal-world evidenceSafety of medical productsHealth recordsHealth systemReal-world dataTrial emulationPrimary end pointInsurance claimsPhase 2Placebo comparatorActive comparatorInterventionEligibilityEnd pointsTrialsSurrogate Markers and Clinical Outcomes—Reply
Wallach J, Ramachandran R, Ross J. Surrogate Markers and Clinical Outcomes—Reply. JAMA 2024, 332: 936-937. PMID: 39167385, DOI: 10.1001/jama.2024.14279.Peer-Reviewed Original ResearchPremarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyHarnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies
Miller J, Pelletiers W, Suttiratana S, Mensah M, Schwartz J, Ramachandran R, Gross C, Ross J. Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies. BMJ Medicine 2024, 3: e000920. PMID: 39175919, PMCID: PMC11340651, DOI: 10.1136/bmjmed-2024-000920.Peer-Reviewed Original ResearchUS Food and Drug AdministrationFood and Drug AdministrationClinical trialsReference standardDrug AdministrationInternational Federation of Pharmaceutical ManufacturersTrial designPhases of clinical trialsEuropean Medicines AgencyEnrollment targetsPharmaceutical company websitesTrial recruitmentPatient populationImprove patient awarenessInternational FederationMedicines AgencyWorld Health OrganizationEligibility criteriaCompany policiesDiversity policiesStakeholder guidanceTrialsFDAPharmaceutical Research and Manufacturers of AmericaCharacteristics of participantsConsent Form Reporting on ClinicalTrials.Gov, 2013-2023
Axson S, Ramachandran R, Lisenby A, Giordano N. Consent Form Reporting on ClinicalTrials.Gov, 2013-2023. JAMA Network Open 2024, 7: e2418895. PMID: 38904965, PMCID: PMC11193120, DOI: 10.1001/jamanetworkopen.2024.18895.Peer-Reviewed Original ResearchHPR82 Assessment of Supporting Evidence and Postmarketing Requirements for Therapeutic Indications With Real-Time Oncology Drug Review, 2018-2023
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. HPR82 Assessment of Supporting Evidence and Postmarketing Requirements for Therapeutic Indications With Real-Time Oncology Drug Review, 2018-2023. Value In Health 2024, 27: s208. DOI: 10.1016/j.jval.2024.03.1151.Peer-Reviewed Original ResearchHPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates
Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. HPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates. Value In Health 2024, 27: s214. DOI: 10.1016/j.jval.2024.03.1178.Peer-Reviewed Original ResearchAssociations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug AdministrationFunding of evidence included within public comments submitted to inform Medicare national coverage determinations
Lu A, Ji R, Magee M, Ross J, Ramachandran R, Redberg R, Dhruva S. Funding of evidence included within public comments submitted to inform Medicare national coverage determinations. Health Affairs Scholar 2024, 2: qxae064. PMID: 38919964, PMCID: PMC11196998, DOI: 10.1093/haschl/qxae064.Peer-Reviewed Original ResearchCenters for Medicare & Medicaid ServicesScientific journal articlesNational Coverage DeterminationPublic commentsCoverage determinationCross-sectional studyMedicare national coverage determinationsJournal articlesMedicare coverage decisionsCoverage of itemsMedicaid ServicesMedicare beneficiariesCommentsMedicare coverageGreater fundingMedicareAuthor disclosuresArticleCoverage decisionsEvaluation of benefitsFunding statementsSupport researchImplications for Public Health Regulation if Chevron Deference Is Overturned
Agrawal S, Ross J, Ramachandran R. Implications for Public Health Regulation if Chevron Deference Is Overturned. JAMA 2024, 331: 1443-1444. PMID: 38506706, DOI: 10.1001/jama.2024.3654.Peer-Reviewed Original ResearchPremarket 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 ResearchCharacterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study
Mooghali M, Mitchell A, Skydel J, Ross J, Wallach J, Ramachandran R. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study. BMJ Medicine 2024, 3: e000802. PMID: 38596814, PMCID: PMC11002412, DOI: 10.1136/bmjmed-2023-000802.Peer-Reviewed Original ResearchNational Comprehensive Cancer NetworkNational Comprehensive Cancer Network guidelinesComprehensive Cancer NetworkFood and Drug AdministrationCancer NetworkUS Food and Drug AdministrationCategories of evidenceAccelerated approvalCross sectional studyDrug treatmentConfirmatory trialsClinical benefitTrial resultsOncological indicationsTraditional approvalGuideline recommendationsOutcome measuresSectional studyApproval statusFDA decisionRecommended alignmentOncologyUpdate recommendationsPostapproval trialsGuidelinesLessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications.
Nagel K, Ramachandran R, Lipska K. Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications. Diabetes Care 2024, 47: 1246-1256. PMID: 38536964, PMCID: PMC11272967, DOI: 10.2337/dci23-0042.Peer-Reviewed Original ResearchOut-of-pocket paymentsInflation ratePrice hikesPolicy prescriptionsPriceReduced priceHealth insuranceMarket entryPolicy evaluationDrug pricesGovernment negotiatorsBiosimilar competitionPharmacy benefit managersAnticompetitive practicesInflationFederal interventionIncreased enforcementPolicyInsulin pricesPublication productivityReduction ActFederal levelDrug manufacturersBenefit managersCompetitionMedicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016–2019 data
Qureshi O, Ramachandran R, Ross J. Medicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016–2019 data. Journal Of Pharmaceutical Policy And Practice 2024, 17: 2312374. PMID: 38434725, PMCID: PMC10906125, DOI: 10.1080/20523211.2024.2312374.Peer-Reviewed Original ResearchDrug spendingPrice negotiationsPrescription drug expendituresAnnual drug spendingInflation Reduction ActMedicare pricesSpending dataReduction ActMedicare spendingDrug expendituresSpendingDrug pricesCenters for Medicare & Medicaid ServicesMedicare Part BInflationPriceAnnual Medicare spendingEligibility requirementsMedicareNegotiationExpenditureUS FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion
Patel N, Mohammad A, Ross J, Ramachandran R. US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion. The BMJ 2024, 384: e076138. PMID: 38383007, DOI: 10.1136/bmj-2023-076138.Peer-Reviewed Original Research
2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original ResearchAssociation of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies
Wallach J, Gautam A, Ramachandran R, Ross J. Association of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies. The BMJ 2023, 383: e077166. PMID: 38123175, DOI: 10.1136/bmj-2023-077166.Peer-Reviewed Original Research