get the dose right · get the dose right with compass. compass. is cytel's software package...
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Get the Dose Right
Get theDose Right
TM
TMKey Features & Benefits• Modelaccrualsandresponsetime
• Flexiblyallocatesubjectsincohortstoasingleormanydoses
• Generateresponsedatathroughdose-responsemodels
• Modifysimulationsusingyour• ownRcode
• Validatedandtestedsoftware,currentlyusedattheFDA
• Powerfulcustomizablesimulationenginesforsensitivityanalysisandprediction
• Customizablechartsandtablestoenhancecommunicationwithstakeholders
• Powerfulresponse-adaptiverandomizerandlogfile
• Excellentusermanual,helptools,andtechnicalsupport
Design OptionsFrequentistUpanddownwith1or2targetsT-testbasedupanddownwith1or2targetsMaximizingdesignANOVA2-stagedesigns
Adjust p-values using Bonferroni, Simes, Sidak, Dunnett; Combine p-values using Inverse Normal, Fisher's Product
BayesianFourparameterlogisticEmaxNormalDynamicLinearmodel2-stagedesigns
TargetsAbsolutedifferencesDifferencesfromPlaceboQuantilesofthedose-responsecurveBestdoseRspecifiedtarget
Allocation logicsProbabilitythatthedoseisatargetReductioninstandarddeviationRspecifiedallocationlogic
Early stoppingFutility
Efficacy
Simulation outputsSummarystatisticsSimulation-specificstatsPatientlevelsimulationdataDesignsimulationcomparisons
PlotsDoseresponsecurvesDistributionofsubjectsSubjectresponseMeansquarederrorEstimatedmeans/proportionsTargetdosesMCMCdiagnosticsCredibleintervals
What’s new in Compass 2.0?• Randomizationdashboardforadaptivedose-findingtrialexecution• Two-stageBayesianandFrequentistdesignsforadaptivelydroppingdoses• FasterBayesianMonteCarloalgorithms• Earlystoppingforfutilitybyconditionalpowerinfrequentistdesigns
www.cytel.com
www.cytel.com
Request an Evaluation Today T: +1.617.661.2011
Get the Dose Right with CompassCompassisCytel'ssoftwarepackagededicatedtothedesign,simulation,andexecutionofearlyphaseclinicaltrials.Identify-ingtherightdoseisessentialforlaterstageclinicalsuccess,andultimately,marketapproval.
Compassprovidesasystematicwaytoinvestigateandcompareconventionalversusadaptivedose-findingdesigns.Theadap-tiveapproachescanhelpacceleratedevelopmenttimelines,reducingpatientsandcosts.
CompassistheonlysoftwaresolutionwithbothBayesianandfrequentistadaptivemethods,andRcodeextensibility.Thein-sightfulsimulationandvisualizationtoolsallowyoutoexploretheoperatingcharacteristicsandpracticalimplicationsofyourdesign.
Onceadesignhasbeenchosen,Compasswillperformtherandomization,conductinterimanalysisonimporteddata,andupdateallocationforthefollowingcohort.Arandomizationdashboardallowsyoutomonitortheinterimdataquicklyandeasily,whileadetailedlogfileensurestheintegrityofyourtrial.
EmpowerPlayamorestrategicroleinyourorganization.Compasssimplifiesandautomatesstudydesignandsimulation,freeingmoreofyourtimetocontributeingreaterwaystothesuccessofyourtrialorprogram.
AssessRapidlygeneratemultipleadaptiveorconventionalearlyphasedesigns.Easilyperformsensitivityanalysistoquicklyevaluateadesign'srobustnesstocriticalassumptions.Usethetablesandgraphstocomparetheoperatingcharacteristicsofdifferentapproaches.
ShareCommunicatethemeritsofatrialplantotheprojectteamwiththehelpofreadilyunderstoodgraphs,tables,andflexiblereportingcapabilities.Sharedesignpropertiesinrealtime.
TrustCompasshasbeenintensivelytestedandvalidated.Toexecuteadose-findingtrial,relyonthesamedoserandomizationalgo-rithmsthatpowerthesimulations.Anautomaticallygeneratedlogfileprovidesanaudittrailofdecisionsmadethroughoutthetrial.
Accelerate the Design, Simulation, and Execution of Dose-Finding Studies
• Simple two-stage designs for adaptively dropping doses
• Several methods for adjusting and combining p-values
• Early stopping rules by conditional power
TM
• Automatically performs interim analysis and adaptive randomization
• Randomization dashboard to monitor interim data
• Log file with audit trail to ensure integrity of trial
Get the Dose Right
Get theDose Right
TM
TMKey Features & Benefits• Modelaccrualsandresponsetime
• Flexiblyallocatesubjectsincohortstoasingleormanydoses
• Generateresponsedatathroughdose-responsemodels
• Modifysimulationsusingyour• ownRcode
• Validatedandtestedsoftware,currentlyusedattheFDA
• Powerfulcustomizablesimulationenginesforsensitivityanalysisandprediction
• Customizablechartsandtablestoenhancecommunicationwithstakeholders
• Powerfulresponse-adaptiverandomizerandlogfile
• Excellentusermanual,helptools,andtechnicalsupport
Design OptionsFrequentistUpanddownwith1or2targetsT-testbasedupanddownwith1or2targetsMaximizingdesignANOVA2-stagedesigns
Adjust p-values using Bonferroni, Simes, Sidak, Dunnett; Combine p-values using Inverse Normal, Fisher's Product
BayesianFourparameterlogisticEmaxNormalDynamicLinearmodel2-stagedesigns
TargetsAbsolutedifferencesDifferencesfromPlaceboQuantilesofthedose-responsecurveBestdoseRspecifiedtarget
Allocation logicsProbabilitythatthedoseisatargetReductioninstandarddeviationRspecifiedallocationlogic
Early stoppingFutility
Efficacy
Simulation outputsSummarystatisticsSimulation-specificstatsPatientlevelsimulationdataDesignsimulationcomparisons
PlotsDoseresponsecurvesDistributionofsubjectsSubjectresponseMeansquarederrorEstimatedmeans/proportionsTargetdosesMCMCdiagnosticsCredibleintervals
What’s new in Compass 2.0?• Randomizationdashboardforadaptivedose-findingtrialexecution• Two-stageBayesianandFrequentistdesignsforadaptivelydroppingdoses• FasterBayesianMonteCarloalgorithms• Earlystoppingforfutilitybyconditionalpowerinfrequentistdesigns
www.cytel.com
www.cytel.com
Request an Evaluation Today T: +1.617.661.2011