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Automating Signal Detection to Efficiently Manage Safety
Data
In order to ensure patient safety and comply with
pharmacovigilance regulations, massive
amounts of safety data must be analyzed. Arithmos explains how
automating pharmacovigilance
systems can improve the identification of adverse events through
real time data results.
Pharmacovigilance Regulaons: Signal Management
Regulatoryauthoriesandgoverningbodieshavetakenstepstoimprovepaentsafety.TheEuropeanUniontook
acon in Julyby implemenng the first sevenmodules of new
pharmacovigilance legislaon. The changes are
designedtotacklethestartlingstascthat200,000paentsintheEUdieeachyearfromadversedrugreacons
(ADRs).
Partof the implementaonplan is tobeeranalyzeandunderstanddata
fromclinicalstudies especiallypost
marketstudies to
idenfyriskstopaents.OneofthemoresignificantmodulestopassinJulywasModuleIX:
SignalManagementwhich
includesrequirementsonthestascalanalysisandsystemsusedtodetectsignals.It
alsooutlineshowdatashouldbeassessedbyaQualifiedPersoninamelymanner,howtheprocessshouldbe
documentedandhowurgentaconshouldbetakenwheneverasafetyissuearises.
The Industry Need
Duetotheincreasedregulaononsafetydataandthe
needtoimprovedataquality,signaldeteconbecomes
very data intensive and difficult to manage.
Pharmaceucal companies are searching for a signal
detecon soluon that can produce real me results
with accurate signal idenficaon at an affordable
operaonalcost.
Idenfyingadverseeventsrequires laboriousstascal
analysis of aggregate data. However, technology can
facilitate the automaon of signal detecon to help
reducetheworkload.
Combining Stascal Programming & Data Integraon
Technology
Combiningstascalanalysis,stascalprogrammingandITsupportunderacommonlyusedplaormlikeSASis
anidealsoluonforautomangdatacolleconandanalysisfrommulplesourcestoimplementanefficientsignal
deteconprocess.Inordertoautomatetheprocess,asystemneedstobeinplacetopullandanalyzedatafrom
thesafetydatabase.
ThestascianwringtheStascalAnalysisPlan(SAP)mustfirst
idenfy,togetherwiththepharmacovigilance
unit, the algorithms to be implemented in the analysis, ensuring
that themethod used is appropriate to
thedataset.Then,collaborangwith ITandSASprogrammers,
thestascianmustdefine thedatamappingof the
databasefields.Thekeyaspectsinthissoluonisdataintegraonbetweensafetydatabases,regulatorydatabases
and paent data from externaldatabase sources aswell as choosing
the best stascal analysismethod. This
allowsthestascalprogrammingteamtoefficientlyproducelinelisngsandsummarytabulaons.
Thetypicalprocessflowforsignaldetection.
A TECHNOLOGY PARTNER FOR INNOVATIVE SOLUTIONS IN CLINICAL
TRIALS.
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The idenficaon of signal criteria and the implementaon of
standardized programs automates the signal
detecon process. It also produces structured data which speeds
up the task of finalizing Eudravigilance
submissions.
Thisapproachisappropriateevenforsmallcompanies,orforproductswithsmallamountsofsafetydata,because
automaoncanbedonewithoutacomplexorexpensiveBusinessIntelligenceplaorm.
ARITHMOS Case Study: Producing Pharmacovigilance Reports Using
Data Integraon Technology
A largepharmaceucal company contactedCROSNT, a
CRO focused on biometric services, about doing
stascalanalysisandreporngonadverseeventsfora
suspect drug reported in individual case safety reports
(ICSR). The Sponsor was using a third party adverse
reporng system along with SAS to collect post
markengadversereaconsdata.
This parcular project required a methodological
stascian, a SAS programming team and IT support
providedbyARITHMOS.Basedonrequirementsfromthe
Sponsors Global Pharmacovigilance and Drug Safety
department,thestasciandefinedaStascalAnalysis
Plan for the detecon of Signals of Disproporonate
Reporng (SDRs) requiring a Proporonal Reporng
Raotobeimplemented.
Toproduce line
lisngsandsummarytabulaonforsignaldeteconandreporng,theSponsorneededasetof
SASprogramswhichalloweddatatoberetrievedfromtheARESdatabaseinstantlyandinastructuredmanner.To
usetheseprogramsSASprogrammingknowledge
isnotrequiredbecausetheprogramsareautomacallysetup
forallthevariablesrequired(e.g.Acvesubstance,coveringperiod,etc).Thereforepharmacovigilanceofficersdo
notneedtohaveaknowledgeofSAS.
Theend resultwasanautomatedsignaldeteconprocesswhich leads
tobeeranalysis, real me results,and
structuredandformaeddataforefficientpreparaonofregulatorysubmissions.
FormoreinformaononModuleIXandSignalManagement,visittheEuropeanMedicineAgencyswebsite:
hp://www.ema.europa.eu/docs/en_GB/document_library/Scien
fic_guideline/2012/06/WC500129138.pdf
AboutARITHMOSARITHMOSprovidesITproductsandservicestodifferentindustriesbutwithaspecialfocusonmakingtheconductofclinical
trialsfasterandmoreefficientforPharmaceutical, Biotech
andMedicalDevice
companiesaswellasCROs.ThecompanyprovidesproductsforePRO,EDC,CTMS,Pharmacovigilance,eLearning,DataVisualisationandProjectGovernance.Servicesincludedataintegration,computersystemvalidation,hostingandHelpDesk.Contactusat:[email protected]
CROSNTandARITHMOSproposedproject plantothe
Sponsor
