MCC

MCC: Clinical Trial Performance Metrics At-A-Glance - May 2016

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ForadditionalinformationabouttheMCC,pleasevisit www.metricschampion.org 1 MCCClinicalTrialPerformanceMetrics Version1.2 At A Glance INTRODUCTION TheValueofStandardizedPerformanceMetrics Biotechnologyandpharmaceuticalorganizationsoptimizeclinicaltrialcycletimesby maintainingfocusoncorecompetencies,byoutsourcingservices,andbyprioritizingthefull utilizationofr esources. 1 Performancemetricsareestablishedbythedrugdevelopmentindustry inordertomeasureandstandardizevariouscomponentsofclinicaldevelopmenttimesand clinicaltrialdeliverables.Byusingmetrics,sponsorsandtheiroutsourcingpartners canmanage andtrackqualityandresources — e.g.people,time,andmoney — inordertogaugethe productivityandefficiencyofeachoverthecourseofaclinicaltrial. Thisallowsthedrug industrytoreducedrugdevelopmenttimesandcosts,anddramaticall yincreaseproductivity whilemaintainingquality.Standardizedperformancemetricsimproveresearch&development strategiesandperformance,bothwithinacompanyandacrosstheentiredrugdevelopment industry. BuildingPartnershipsAroundStandardize dPerformanceMetrics Inordertostandardizemetricsthroughoutthedrugdevelopmentindustry,theMetrics ChampionConsortium(MCC)wasformedbybiotechnology,pharmaceutical,andservice providerorganizationswiththeultimategoalofimprovingtheef ficiencyandeffectivenessof clinicaltrials.Sponsorsandserviceproviderorganizationsbenefitbybeingabletocompare clinicaltrialperformanceacrossallofasponsor'sstudies,eveniftheyutilizemultipleservice providers.Together,sponsorsan dserviceproviderscanreviewperformanceandidentifybest practicescenariosaswellasopportunitiesforimprovement — andthendetermineappropriate actionstepstoimproveperformancefortheprocessesinquestion. Throughoutthemetricsdevelopment andimplementationprocess,theMCCprovidesa safe harborfor biotechnology,pharmaceutical,andserviceproviderorganizationstosharebest practicesandlearnfromeachotherthroughparticipationinMCClearningforumsand collaborativeworkgroups. THEMCCMETRICDEVELOPMENTPROCESS TheSponsor/ServiceProviderCollaborativeProcess In September2010 , theMCCClinicalTrial PerformanceMetricsv1.0definitionswerereleased. Theseperformancemetricsweredevelopedthroughacollaborativemetric development processcompletedovera 2 year period[Figure1].Agroupof morethan3 0 sponsorsandCROs established thev1.0 setofstandardized performancemetrics withtheinputofmorethan2 00 workgroupparticipants andmanyadditional industryrepres entatives.Themissionofthegroup wastodevelopandsupportabaselinesetofperformancemetrics thatmeasurespecificclinical trialplanningandexecutiontasks.Themetricsarek eyindicatorsofperformanceand inthe eventthatperformancedoesnot meettargetexpectations, allowfor"additionalforcause analysis" . 1 KaitinKI."PushingtheInnovationEnvelope:DrugDevelopmentMetricsandtheChan gingDynamicsof PharmaceuticalR&D."Presentedatthe6thAnnualPharmaceuticalMetricsEvent:DrivingQuality,Cost,& Time;October16 – 18,2007;Cambridge,MA.

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