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

Partners Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 1.INTRASOFT INTERNATIONAL SA, Belgium 2.UNIVERSITY OF CYPRUS, Cyprus 3.DERI-NATIONAL UNIVERSITY OF IRELAND, GALWAY, Ireland 4.UNIVERSITY OF MANCHESTER, UK 5.CENTRE FOR RESEARCH AND TECHNOLOGY HELLAS (CERTH), Greece 6.SIVECO Romania S.A 7.UBITECH Research, Greece 8.GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER (LUH), Germany 9.Cyprus Institute of Neurology and Genetics (CING), Greece 10.ZEINCRO Hellas S.A., Greece 11. HOSPICES CANTONAUX CHUV, Switzerland 2/15

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

Showcases Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe  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 DrugX association 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

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 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe 5/15

Safety First – Ethical & Legal Aspects Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe  Respect patients’ 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) 6/15

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

Is data anonymised enough ? 16 year old widow Problem Marital Status Age MarriedWidowedSingle ~ /15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

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

Perturbation and Cell Suppression Original Data Marital Status Age Married Widowe dSingle ~ Marital Status Age Married Widowe dSingle 0-16NA ~ Perturbation (+-1) and Cell Suppression (<5) 10/15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

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

Semantic EHR Model ACGT BFO imports Domain SEHR CHUV Cardiovascular Psychiatric Adverse Events CING Breast Cancer Diabetic Neurology Genetics Adverse Event (AE) ZEINCRO Adverse Event (AE) Concomitant Medication (CE) Respiratory UPPER UMLS, OBO Foundry (Basic Formal Ontology) Advancing Clinico-Genomic Trials on Cancer (ACGT) Class1859 Object Property225 Data Property575 12/15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

Policy-Based User Restricted Resources R1R3 P1 R4 P3 R2 P2 R5 P4 Data Cube + R1# P4 Query R1R5 P4 Result R1R3 R5 P4 View P1 R1 # P1 # # P4 Access Policy   13/15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

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

Contact Dr. Ratnesh Sahay, Dr. Ronan Fox DERI, NUIG Tel: Fax: Join Thank You 15/15 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe