Presentation on theme: "A Coherent and Practical End-to-End Metadata Strategy using Existing Standards and Tools for Clinical Research Stephane AUGER Danone Research, FRANCE."— Presentation transcript:
1 A Coherent and Practical End-to-End Metadata Strategy using Existing Standards and Tools for Clinical ResearchStephane AUGERDanone Research, FRANCE
2 Clinical studies performed in 4 divisions Historically CONTEXTClinical studies performed in 4 divisionsDairy, Waters, Baby and Medical NutritionHistoricallyMostly paper-based studies until very recentlyDM Outsourced to CROsFew internal data / metadata standardsResultFew controls on data / metadata received from CROsLack of homogeneity between studiesResource intensive to pool for meta analysis orformat for a DR/DWToday i’d like to share with you the results of a project that we’ve had ongoing now for almost 3 Danone Research on implementing a metadata strategy for our clinical studies.…and today i’m going to focus on the metadata strategy that we’ve put in place in our Dariy and Waters divisions.
3 “First, we need to get more control over our clinical study metadata” CONTEXT2010Upper management request for a “Data Warehouse”“First, we need to get more control over our clinical study metadata”Thought process to address the end goal:Use existing tools/software as much as possibleStandardize up front… CDISC SDTM, CDASH, ODMA bonus if we could make metadata management and study set-up more efficientAnd so this metadata strategy project began in 2010 when I received a request from my….…and what I told them at the time was that we were nowhere near ready to implement a DW. And that a DW was the End-Result of a project that begins with getting ………and so we launched this project with a few things in mind…..
4 Key Decision #1: Metadata Standards Management (1) Implementation of a Study Metadata Modeler (SMM) … with a duel useManage Study Metadata StandardsCRF Forms, Item Groups, Items, CodelistsItem Characteristics (type, formats, range values etc.)CRF completion guidelines / help textDatabase structureBased on SDTM/CDASHThe first key decision that we made is this project was to implement a SMM,…..and the 1st thing that this tool allows us to do is…The tool really provides us with an environment where we can define and manage all of our metadata standards for our CRF moduelsNot so easy to do – need to plan for multiple EDCs and limitations of those EDCs – vertical vs. horizontal structure. Eg of Vital Signs
5 Key Decision #1: Metadata Standards Management (2) Implementation of a Study Metadata Modeler (SMM) … with a duel useCreate Study-Specific MetadataUse Metadata Library to create a study-specific “CRF”Export study-specific “CRF” in ODM format to an EDC system→Requires ODM-compatible EDC systemThe 2nd thing that this tool allows us to do, is to capitalize on our metadata standards library to create a study-specific CRF in a non-programming environment.…and really, the key point here is that..…we are able to export, from the SMM, the study-specific CRF metadata in ODM format…..which we can later exploit by an EDC tool….which of course needs to be ODM compatible
6 SMM EDC SMM Functionality CRF DB Structure Simple Edit Checks Workflow Config.ODMDB StructureComplexEdit ChecksSimpleEdit ChecksDatabase Admin.ODMVisit LayoutIWRSCodingTSDVCustom AttributesCustom Configuration
7 Key Decision #1: Metadata Standards Management (3) SMM - Implementation ExperienceDefine company standard CRF forms and variablesWorkgroups representing Clin Ops, QA, Statistics, Data Management1 year – 80 man/daysResulted in a Data Standards Committee and change management processDefine standard DB structure in the SMMEach EDC has different production database specificitiesOne library for multiple EDC systemsSMM provider an essential resource3 months – 60 man/days..Some of the return-on-experience from this phase of the project:We created workgroups in order to define our company-standard CRF forms and variables… with representation from each group of internal stakeholders.With respect to defining the standard DB structure, this part was a little more tricky, and we really relied on our SMM vendor and their experience with different EDC systems, and each of their unique ways of handling data.and this was key, because we wanted ONE standards library to be as flexible as possible
8 Key Decision #2: ODM-Compliant EDC (1) Implementation of ODM-compliantEDC tool(s)ODM-inImport Study-Specific CRF metadata - ODM fileODM-outExport study metadata & study data in ODMThe 2nd Key Decision that we made in this project (as you can guess)– was to select an EDC tool that was ODM compliant.Now i’m not going to get into the debate today of what ODM compliance means - as they only gave me 20 minutes to talkBut, generally, the two main things that were looking for was that the EDC could:import our study specific CRF metadata to facilitate the study build…and that we could also Export the study metadata as well as the actual clinical study data
9 Study Set-up: What’s left to do? SMMEDCCRFWorkflow Config.Visit LayoutODMComplexEdit ChecksSimpleEdit ChecksDatabase Admin.ODMDB StructureSo, what parts of the EDC study set-up are still left to configure once we’ve imported our metadata from the SMM?So, highlighted in yellow here are the tasks that still need to be configured in the EDC tool itself before study launch.Medical CodingCustom AttributesTSDV
10 Key Decision #2: ODM-Compliant EDC (2) Implementation ExperienceMany challenges to overcome and details to solveSMM & EDC implementation at the same timeRequires tech-savy personnel60-80% of the EDC study build is done automatically in this processMain differences between our two EDC toolsTwo-step ODM import processVisit configurationComplex edit checks need to be re-configuredOur return-on-experience from this phase of the project:As you can imagine, there were …… especially considering that we were implementingAfter our test phase and our first two implementations, we’ve estimated that…..
11 Key Decision #2: ODM-Compliant EDC (3) Implementation Experience (2)Impact on EDC budget?75% decrease in professional service costs62% decrease in overall EDC budgetImpact on Data Management Resources?No Change in Study Build FTEs (but more tasks performed internally)≈50 decrease in study set-up time (Protocol to EDC Go-Live)≈ 20% increase in overall DM study budget (vs. Paper-based)Database &EDC Set-upCRF = EDC Set-upReduced ProgramingReduced ValidationMetadata ControlStandardizationEfficiencyWarehouse-ready dataAs we are in our 1st few studies with this implementation – we will get a better with the next few studies exactly how the FTEs will be affected, but for the first few studies – no change.so not in the # of man days, but in the time interval from Protocol to EDC Go-Live..and what are we getting for this 20%
12 Roles and Responsibilities EDC VendorCROComplexEdit ChecksHosting & SupportSMMCRF & Study BuildValidationDanone(Data Manager)Custom Config. / ReportsWorkflow Config.In-Study DMDatabase Admin.EDCODM InDatabase LockStudy-Specific validation is greatly reduced since standards are used from the beginning.
14 Key Decision #3: ODM-Compliant Mapping Tool Implementation of ODM-compliantMapping (ETL) toolMaps ODM (from the EDC) to produce:SAS transport datasets (SDTM format)Define.xmlStandardized ODMStandard Mapping MetadataRe-Usable mapping scriptsValidation = only once
16 Clinical Study Data & Metadata Flow: Tools BuildConductExploitMETADATAMetadata Standards & Study Set-up(Formedix)METADATA + STUDY DATAData Collection (EDC)(Medidata RAVEOpenClinica)Mapping(XML4Pharma)Data Repository
17 Clinical Study Data & Metadata Flow: Management BuildConductExploitMETADATAMetadata Standards & Study Set-up(Formedix)METADATA + STUDY DATAData Collection (EDC)(Medidata RAVEOpenClinica)Mapping(XML4Pharma)Metadata Standards & ManagementData Repository
18 Clinical Study Data & Metadata Flow: Standards BuildConductExploitMETADATAMetadata Standards & Study Set-up(Formedix)METADATA + STUDY DATAData Collection (EDC)(Medidata RAVEOpenClinica)SDTM/CDASHMapping(XML4Pharma)SDTMData RepositoryDefine.xmlODM
19 End-to-End metadata standardization and control is possible ConclusionEnd-to-End metadata standardization and control is possibleThere are significant cost and time savings to be had!The tools and standards are ready and available NOW