1. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Enabling clinical research in West Midlands: ePCRN, TRANSFoRm and CuRE projects Slide 1 Theodoros N. Arvanitis, RT, DPhil, CEng, MIET, MIEEE, AMIA, FSIM, FRSM Professor of e-Health Innovation Institute of Digital Healthcare, WMG, University of Warwick Birmingham Children’s Hospital NHS Foundation Trust

2. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Clinical Trial Management SystemsDevelopment of Clinical Trial Management Systems that provide, through an integrated infrastructure, a wide-ranging set of modular, interoperable and standards based tools designed to meet the needs of clinical trials Objectives of e-trials system implementation “computable” –To define a “computable” model representation that supports the entire life-cycle of clinical trials protocol, develop –To develop appropriate tools that use the model representation. translating research into clinical practice Slide 2

3. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Clinical trials life-cycle Adapted from Source: Douglas Fridsma, MD, PhD The University of Pittsburgh Cancer Institute Centre for Pathology and Oncology Informatics Clinical Trials Research Core Slide 3

4. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Learning Healthcare System Slide 4 Safer Clinical Practice B. C. Delaney, K. A. Peterson, S. Speedie, A. Taweel, T. N. Arvanitis and F. D. R. Hobbs, Envisioning a Learning Health Care System: The Electronic Primary Care Research Network, A Case Study, Annals of Family Medicine, 10(1):54-59, 2012. More research evidence Software Integration Interoperability Services Software Integration Interoperability Services Epidemiological Studies & RCTs Knowledge Translation

5. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 electronic Primary Care Research Network The electronic Primary Care Research Network (ePCRN) was an NIH Roadmap funded project designed to explore the feasibility of conducting clinical trials in the community– specifically in primary care settings. The ePCRN electronically links a variety of primary care practices and facilitates secure communication with those practices thereby protecting the privacy and confidentiality of the patient. There are three primary components to the ePCRN: trialist workbench 1.a trialist workbench for designing clinical trials clinical trials’ management component 2.a clinical trials’ management component for conducting and managing clinical research studies. translating research into practice 3.Tools for translating research into practice Slide 5

6. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 ePCRN: US/UK perspective Slide 6

7. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 ePCRN Study and eCRF tools Design Study Collect Data Analyse Data Protocol Timeline CRFs Study Database The following provide some example screenshots of the eCRF technology on a current ePCRN prototype Slide 7

8. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Protocol Design Slide 8

9. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Timeline Design Slide 9

10. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 eCRF Design Slide 10

11. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Acknowledgments for ePCRN Re-Engineering the Clinical Research Enterprise ePCRN Contract No. HHSN268200425212C Slide 11

12. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Specific research knowledge Actionable knowledge Routinely collected knowledge knowledge in healthcare Clinical trials Controlled populations Well-defined questions EHR systems Wide coverage Vast quantity May lack in detail and quality Distilled scientific findings Usable in clinical practice Decision support Slide 12

13. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Informatics tower of Babel: the grand challenge Overwhelming volume of data Multitude of sources Each part of the health community speaks its own scientific “dialect” (e.g. lab values, genetic profile, clinical data) Lack of consensus on common standards and terms Lack of coordination across, and collaboration within, the cancer research enterprise Integration is critical to achieve promise of molecular medicine (personalised medicine) Slide courtesy of caBIG™ Slide 13

14. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 TRANSFoRm Itegrated VS The TRANSFoRm Integrated Vocabulary Service is designed to allow end users to search and retrieve clinical vocabulary concepts and associated content –a web interface and a web service API –the service uses the LexEVS (version 5.1 and version 6.0) technology to access a backend UMLS vocabulary database –the service uses direct Java Database Connectivity (JDBC) to access other vocabulary databases (e.g. Read Codes V2, ICPC2) Slide 14

15. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 A screenshot of the vocabulary service web-based interface Slide 15

16. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Example eligibility criterion HbA1c test result of ≥ 6.5% on or before the 16/04/2013. –laboratory_Test_Type_ID=[LOINC;4548-4] –laboratory_measurement_datum ≥ 6.5 –laboratory_measurement_unit_label = [UO;0000187] –lab_result_confirmation_instant ≤ 2013/04/16 Slide 16

17. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Identifying prevalent cases through eligible counts TRANSFoRm Query Workbench Identifying prevalent cases through eligible counts Slide 17

18. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 acknowledgments: TRANSFoRm Consortium Slide 18

19. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 CURe Example user interface for selecting medication medications use the dictionary of medicines and devices (dm+d). CURe (Comprehensive Unified Research) is a framework for the development of software systems for research. It has been developed to create extensible research systems for various medical conditions. Common data elements to all medical areas, as well as specialist requirements can be handled by the framework. Slide 19

20. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Acknowledgments for CURe Slide 20

21. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 realising our imagination: facing challenges Slide 21 "Leave the beaten track occasionally and dive into the woods. Every time you do so, you will be certain to find something that you have never seen before. Follow it up, explore all around it, and before you know it, you will have something worth thinking about to occupy your mind. All really big discoveries are the result of thought." Alexander Graham Bell: "electrical speech machine" of 1876

22. AHSN Digital Health Event, iHouse, Coventry Professor T.N. Arvanitis - 13/12/2013 Thank you t.arvanitis@warwick.ac.uk Slide 22