Ensuring Patient Safety in Clinical Trials FP7 Project: Linked2Safety

1. Ensuring Patient Safety in Clinical Trials FP7 Project: Linked2Safety Dr. RatneshSahay, Dr. Ronan Fox DERI, NUIG Galway, Ierland Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 1/15

2. Partners INTRASOFT INTERNATIONAL SA, Belgium UNIVERSITY OF CYPRUS, Cyprus DERI-NATIONAL UNIVERSITY OF IRELAND, GALWAY, Ireland UNIVERSITY OF MANCHESTER, UK CENTRE FOR RESEARCH AND TECHNOLOGY HELLAS (CERTH), Greece SIVECO Romania S.A UBITECH Research, Greece GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER (LUH), Germany Cyprus Institute of Neurology and Genetics (CING), Greece ZEINCRO Hellas S.A., Greece HOSPICES CANTONAUX CHUV, Switzerland Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 2/15

3. The Problem Legal and Ethical Regulations HL7/openEHR return number of subjects (i.e., patients) that have been administered the drug Insulin and exhibit BMI > 25 and Dyslipidemia and Agoraphobiaas adverse events DSM-4 LOINC SNOMED RxNorm Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 3/15

4. Showcases • Phase III Clinical Trial – Subject Selection Criteria • the unbiased randomised selection of subjects in phase III clinical trials • e.g. return subjects with diabetesValue > 4 and weight >80 and hasCancer • Phase IV – Post Marketing Surveillance • the pharmacovigilance of a drug after it receives permission to be sold • e.g. Test DrugXassociation with headaches • Phase IV – Chemoinformatics • identification of relations between molecular fragments and specific adverse drug event categories • e.g. Test chemicalFragmentX (of DrugX) with rash 4/15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

5. Objectives • Enable Patient Safety in clinical trials • anonymisation of clinical site • anonymisation of clinical data • Build a semantically-interlinked medical information space • recruit patients across European clinical data sets • adverse event detection • Support effective organization and execution of clinical trials • embedding governance / legal / ethics in process 5/15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

6. Safety First – Ethical & Legal Aspects • Respectpatients’ anonymity, data’s ownership and privacy • Not possible to transfer or copy patient data from the originating institutions • All machines that hold patient data are need to remain off-line • Clinical data will not be identifiable and should not lead to the identification of a person’s identity (either directly or indirectly e.g. back-tracing) • Strictly adhere to consent form requirements and all ethical and legal issues (European and national) Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 6/15

7. Data Anonymisation • Addresses legal and ethical issues by • Closed-world room pre-processing • Usage of data-cubes Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 7/15

8. Is data anonymised enough ? 16 year old widow Problem Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 8/15

9. Is data anonymised enough ? 16 year old widow Problem 9/15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

10. Perturbation and Cell Suppression Perturbation (+-1) and Cell Suppression (<5) Original Data Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 10/15

11. Linked2Safety – Approach Semantic EHR Model Policy Model Linked Data Cubes Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 11/15

12. Semantic EHR Model BFO UMLS, OBO Foundry (Basic Formal Ontology) UPPER imports ACGT imports Advancing Clinico-Genomic Trials on Cancer (ACGT) SEHR ZEINCRO Adverse Event (AE) Concomitant Medication (CE) Respiratory Domain CHUV Cardiovascular Psychiatric Adverse Events CING Breast Cancer Diabetic Neurology Genetics Adverse Event (AE) Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 12/15

13. Policy-Based User Restricted Resources P1 R1 R3  R2 R4 R5 P4 P3 P2 P1 R1 # P4 P4 # # R5 Access Policy  Data Cube P1 R1 R3 + P4 R1 # Query View P4 R1 R5 Result Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 13/15

14. Current Status • Basic prototypes completed • Data-cube building at clinical sites • Special Interest Group (SIG) recruitment • Legal ethical framework and exploitation strategy Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 14/15

15. Join SIG @ http://www.linked2safety-project.eu/user/register Contact Dr. Ratnesh Sahay, Dr. Ronan Fox DERI, NUIG Tel: +353 91 495253 Fax: +353 91 495541 email: firstname.lastname@deri.org Thank You Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 15/15