Secondary use of Clinical Data for Medical Research



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Secondary use of Clinical Data for Medical Research Pr Marc CUGGIA INSERM UMR 936 Faculté de médecine Université de Rennes 1 - CHU de Rennes CrREDIBLE Workshop

Agenda Context and needs in medical research PaKent centered approach : ASTEC PopulaKon centered approach : Clincal DataWarehouse (CDW): ROOGLE CDW Network : EHR4CR / DEBUG IT Current issues and perspeckves 2

RESEARCH Inserm UMR 936 MEDICAL INFORMATICS Biomedical ontologies ac;vi;es ACADEMIC HOSPITAL OF RENNES Biomedical Datawarehouse and databases for research support TEATCHING ACTIVITIES Medical InformaKcs BIOSTATISTICS 3

Medical context ComputerizaKon of PaKent data Health informakon systems : HIS, EHR, Health network records, nakonal EHR (DMP) Other : Health insurance data (medicakon) pakents website : forums, tweets Heterogeneity mulk domains Variable data quality Different formats : numeric or symbolic, Coded or full text +++ No semankc unity : local or internakonal terminologies Components not interoperable

Technologic context Data flood : producing and collecting exponential data Storage capacity Processing capacity Data access capabilities (networks) Manual data retrieval and analysis is becoming impossible Mining Biomedical data is now strategic

Needs in medical research 6

Needs : clinical research Clinical research : new therapy or diagnoskc strategies RecruiKng pakents for studies is expensive : $250 par candidate is difficult : low recruitment è less studies è no research and less money Study in 2006 Havard Benefits for using clinical datawarehouses Save $7 millions on the recruitment cost extrapolakon on the clinical research : $94 à $136 millions [1] R. Nalichowski, D. Keogh, H. C. Chueh, and S. N. Murphy, Calculating the benefits of a Research Patient Data Repository, AMIA... Annual Symposium Proceedings / AMIA Symposium. AMIA Symposium, p. 1044, 2006.

Other medical needs Personnalized medicine : In Silico deteckon of biomarkers for predickng diseases and comorbidikes Health economics and evaluakon of professionnal prackces PaKent trajectory though the healthcare system Public Health : biosurveillances, epidemiology 8

[1]J. Ginsberg, M. H. Mohebbi, R. S. Patel, L. Brammer, M. S. Smolinski, et L. Brilliant, «Detecting influenza epidemics using search engine query data», Nature, vol. 457, nᵒ 7232, p. 1012 1014, févr. 2009.

Health care Process Medical Research process Translationnal medicine

Health care Process Medical Research process HEALTH INFORMATION SYSTEMS RESEARCH INFORMATION SYSTEMS HIS and Hospital EHR Primicare Care EHR National EHR Epidemiologic Registry databases Clinical trial databases OMICs and Biobank Databases Knownledge databases (e.g MEDLINE)

Health care Process Medical Research process HEALTH INFORMATION SYSTEMS RESEARCH INFORMATION SYSTEMS Interoperability (syntackc and semankc) Standards CDISC HL7 DICOM IHE : IntegraKng Health Enterprise

Examples of tools PaKent centered approach ASTEC : recruitment system support 13

Health care Process Medical Research process EHR Clinical trial database Recruitment support system ASTEC

Health Networks Health facilikes MulKdisciplinary meekngs Send pakent data InvesKgator Centers (CRO) Publish CT Eligibility Report ASTEC

NCIT cancer ontology for reasonning InformaKon granularity matching Is-a sterilizakon Criteria Is-a TesKs excision castrakon Is-a Chemical male castrakon PaKent 1 Is-a Bilateral orchidectomy Is-a Radical bilateral orchiectomy Is-a Bilateral total orchitectomy Is-a Bilateral subcapsular orchidectomy PaKent 2

semantic MATCHING sterilizakon Criteria castrakon TesKs excision Chemical male castrakon PaKent 1 Bilateral orchidectomy Radical bilateral orchiectomy Bilateral total orchitectomy Bilateral subcapsular orchidectomy PaKent 2

Examples of tools PopulaKon centered approach Clinical Data Warehouse 18

Health care Process Medical Research process Health InformaKon SYSTEMS Clinical data Research InformaKon System Research data (Omic) Other data sources (PUBMED, ENViRONMENT, DATABASES) CLINICAL DATA WAREHOUSE

Entrepôt de données: ROOGLE R-oogle Chercher Système de recherche d information Metadata Requête Plein texte Indexation Index HIS HOSPITAL 1 HIS HOSPITAL 2 Sillage hexaflux metadata documents Radio Résurgence DX CARE Extract Transform ETL Load

Some examples of CDW technologies I2B2 InformaKcs for integrakng biology and the bedside Harvard TranslaKonnal medicine Murphy SN, Mendis ME, Berkowitz DA, Kohane I, Chueh H. Integration of clinical and genetic data in the i2b2 architecture. AMIA Annu Symp Proc. 2006;p.1040. PMID:17238659. STRIDE Stanford 3 hospitals DétecKon de cohorte ROOGLE : Rennes / Necker InsKtut Imagine / BREST 1. Lowe HJ, Ferris TA, Hernandez PM, Weber SC. STRIDE--An integrated standards-based translational research informatics platform. AMIA Annu Symp Proc. 2009;2009:391 395. [1]M. Cuggia, N. Garcelon, B. Campillo-Gimenez, T. Bernicot, J.-F. Laurent, E. Garin, A. Happe, et R. Duvauferrier, «Roogle: an information retrieval engine for clinical data warehouse», Stud Health Technol Inform, vol. 169, p. 584 588, 2011.

Roogle features Combine queries on structured and free text data (+++) NLP methods NegaKon or uncertainty deteckon SemanKc annotakon, concept extrackon Using UMLS (United Medical Language System) Combining all reference vocabularies

23

TEMPORAL CONSTRAINTS

Résultat : étude de faisabilité SEMANTIC OVERVIEW OF THE RESULT

GENE EXPRESSION

27

28

29

30

RECHERCHE DE L OCCURRENCE DU TERME GRIPPE dans 3 millions de documents 31

Ajout dans un panier

RECHERCHE DE L OCCURRENCE DU TERME GRIPPE dans 10 millions de documents 36

Next step : Querying several hospitals è CDW Network 37

next step Most of studies are mulkcentric Epidemiology, clinical research, pharmacovigilance Need to query different hospitals in the same Kme much more complex heterogenity of data and CDW Cross language barriers Security Business model (Pharma Compagnies) 3 examples : EHR4CR (Clinical Research) DEBUG IT (Biosurveillance) 38

FP7/IMI Inovative medical Initiative Electronic Health Record for Clinical Research Feasibility Screening e- CRF Pharmaco vigilance

Electronic Health Record for Clinical Research Etude Faisabilité Recrutement E- CRF Pharamaco vigilance

Electronic Health Record for Clinical Research Etude Faisabilité Recrutement E- CRF Pharamaco vigilance Rennes : 10 Paris : 230 Londres 223 Genève : 22

42

43

Biosurveillance : DEBUGIT project FP7 InternaKonal survey of bio- resistance of bacteria IntegraKon of ankbiograms and lab test

1. Clinical question 2. Resistance rate evolution 3. Antibiogram tests performed (to give confidence in the rate) 4. Forecasting 5. Monthly aggregated 6. Statistics (mean, standard deviation, etc.)

What is the evolution of the resistance of Pseudomonas Aeroginosa to ciprofloxacin at HUG, INSERM, LIU, TEILAM and UKLFR from 01.06.2007 to 30.06.2009? (use of historic data because the CDRs are not on real time production systems yet)

Current issues SemanKc interoperability Data Quality : Garbage In è Garbage Out «technical» data J Interpreted data L Missing data L SemanKc integrakon Ontology for a large domain Not sufficiently rich or formal Hard to maintain 48

Current issues Reinvent new methods for querying and mining medical data Mining a CDW is not simple as using Google but much more complex Scalability and efficiency OpKmizing the Architecture and the Query method A query execukon should not last more than a coffee break Data proteckon Traceability+++ 49

Next steps SemanKc web Triple Store CDW SPARQL Endpoints CLOUD compukng NLP and indexing IntegraKng new sources 50

Financeurs: ANR TECSAN IMI FP7 CRITT Santé Bretagne Cengeps Collaborateurs : Nicolas Garcelon Denis Delammare Pascal Van Hill Olivier Dameron Acknowlegment - Annabel Bourde - Régis Duvauferrier - André Happe - Isabelle Stévant Wassim Jouini 51