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Get the Dose Right TM

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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

[email protected]

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

[email protected]