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
2000
Treatment Decisions for Localized Prostate Cancer
Holmboe E, Concato J. Treatment Decisions for Localized Prostate Cancer. Journal Of General Internal Medicine 2000, 15: 694-701. PMID: 11089712, PMCID: PMC1495597, DOI: 10.1046/j.1525-1497.2000.90842.x.Peer-Reviewed Original ResearchConceptsExternal beam radiationLocalized prostate cancerWatchful waitingProstate cancerRadical prostatectomyTreatment optionsTreatment decisionsCommon reasonPattern of complicationsPrimary care providersRemoval of tumorsLack of evidencePhysician recommendationConsecutive menCare providersHigh riskPatient decisionCancerLonger durationPractice groupMenBeam radiationTreatmentPatientsShort duration