endeavor在中国临床试验的案例分析.pptxVIP

Story FlowMedtronic global Endeavor clinical program overview, to highlight E-five, PROTECT, China Endeavor Registry, three studies China has been participating inMore information on E-five, FWH’s performance in E-fiveMore information on PROTECT, FWH’s performance in PROTECT (AP newsletter snapshot and Global newsletter snapshot reflecting recognition on FWH’s performance)Summarize what FWH has done right in the above global trials to establish a good reputation on clinical studyIntroducing China Endeavor Registry (CER), use what FWH has done right in E-five and PROTECT to encourage sites participating in CER to speed up patient enrollment while ensuring data qualityCRAs*/MonitorsRandomization SystemData Management Statistical AnalysisCore LabsCEC*Randomized Clinical Study Organization AnatomyCRA: Clinical Research AssociateCEC: Clinical Event CommitteeClinical Study Process Site Initiation TrainingPre study preparationPICRandomizationPatient EnrollmentProcedure and Follow-upCRF Data EntrySolve Data QueriesGenerate Study Report PublicationStudy Close outENDEAVOR I (100 patients)Phase I FIM 48 month resultsDouble-blind Randomized Trial36 month resultsENDEAVOR II (1200 patients)Continued Access Safety24 month resultsENDEAVOR II CA Registry(300 patients)Confirmatory Trial vs. Cypher24 month resultsENDEAVOR III(436 patients)Confirmatory Trial vs. Taxus12 month resultsENDEAVOR IV(1548 patients)Single Arm Trial9 month resultsENDEAVOR Japan(99 patients)Real-World Performance and Safety Evaluation – Enrollment completedE-Five Registry(8000 patients)Endeavor vs. Cypher Safety StudyEnrollingPROTECT(8800 patients)China Endeavor Registry(2200 patients)Real-World Performance and Safety Evaluation – EnrollingENDEAVOR Clinical Program UpdatePhase I FIM 48 month resultsDouble-blind Randomized Trial36 month resultsContinued Access Safety24 month resultsConfirmatory Trial vs. Cypher24 month resultsConfirmatory Trial vs. TaxusEnrollment completedSingle Arm Trial30 days resultsReal-W