2024
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
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 trialsGuidelines
2023
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
Poddar A, Raggio M, Concato J. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019. Therapeutic Innovation & Regulatory Science 2023, 58: 214-221. PMID: 37926768, PMCID: PMC10764372, DOI: 10.1007/s43441-023-00589-z.Peer-Reviewed Original ResearchConceptsBreakthrough therapy statusTherapy statusInsufficient treatment effectNon-oncology drugsReview of requestsUnmet medical needInadequate study designBreakthrough therapy designationConclusionsThis analysisCommon reasonInvestigational drugsUS FoodMedical needOrphan diseaseStudy designDrug evaluationMarketing approvalCorresponding drugsDrugsApproval statusTreatment effectsDrug developmentFDA processDesignation programStatus
2022
Helpful or Harmful? The Therapeutic Potential of Medications with Varying Degrees of Abuse Liability in the Treatment of Substance Use Disorders
Martins B, Rutland W, De Aquino JP, Kazer BL, Funaro M, Potenza MN, Angarita GA. Helpful or Harmful? The Therapeutic Potential of Medications with Varying Degrees of Abuse Liability in the Treatment of Substance Use Disorders. Current Addiction Reports 2022, 9: 647-659. PMID: 35990796, PMCID: PMC9376579, DOI: 10.1007/s40429-022-00432-9.Peer-Reviewed Original ResearchSubstance use disordersUse disordersCocaine use disorderWithdrawal symptomsAbuse liabilityMultiple substance use disordersOpioid use disorderRegulatory approval statusFurther clinical researchPotential abuse liabilityNegative subjective effectsClinical trial researchPharmacological treatmentStimulant medicationPossible treatmentReviewThis reviewTherapeutic potentialTrial researchClinical researchSubjective effectsKetamineDecrease useDisordersGabapentinoidsApproval statusApprovals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
Gupta R, Morten CJ, Zhu AY, Ramachandran R, Shah ND, Ross JS. Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021. JAMA Health Forum 2022, 3: e221096. PMID: 35977259, PMCID: PMC9123500, DOI: 10.1001/jamahealthforum.2022.1096.Peer-Reviewed Original ResearchConceptsCross-sectional studyNovel drugsTherapeutic valueUS FoodDrug AdministrationWorld Health Organization Model ListGeneric approvalCapsule formMultivariable analysisAccelerated approvalClinical usefulnessMAIN OUTCOMEPrescription drugsBrand-name drugsModel ListEssential medicinesDrugsApproval statusMedicine inclusionFDANovel tabletBlockbuster statusApprovalAdministrationDrug sales
2021
Cardiotoxic safety communications after FDA approval of novel cancer therapies.
Bonsu J, Kola-Kehinde O, Kim L, Ruz P, Lustberg M, Brammer J, Addison D. Cardiotoxic safety communications after FDA approval of novel cancer therapies. Journal Of Clinical Oncology 2021, 39: e18629-e18629. DOI: 10.1200/jco.2021.39.15_suppl.e18629.Peer-Reviewed Original ResearchBlack box warningNovel anticancer therapiesHeart failureNovel cancer therapiesThromboembolic diseaseBox warningCancer therapyCardiovascular disease eventsAnticancer therapyMultivariable logistic regressionSudden cardiac deathApproval statusNew safety informationPriority review statusUncontrolled hypertensionCVD eventsCardiac deathCoronary diseaseCVD deathDrug withdrawalElectrocardiographic changesMyocardial infarctionDrug classesLabel warningsMultivariable model
2007
Barriers to phase I clinical trial protocol IRB approval at KCI
Wang D, Heath E, Powell A, Chaperon T, LaGrone F, LoRusso P. Barriers to phase I clinical trial protocol IRB approval at KCI. Journal Of Clinical Oncology 2007, 25: 9080-9080. DOI: 10.1200/jco.2007.25.18_suppl.9080.Peer-Reviewed Original ResearchInstitutional review boardClinical trialsIRB approvalMedian timePhase 1 clinical trialPhase 1 trialPhase 1 protocolPatient accrualAnti-cancer drug developmentStudy designProtocol approvalReview boardFinal approvalPhase IDrug development processSignificant financial relationshipTrialsApproval statusAverage timeHuman subjectsDrug developmentMolecular therapeuticsApprovalInitial review
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