Enabling clinical research in West Midlands: ePCRN , TRANSFoRm and CuRE projects

1. Enabling clinical research in West Midlands: ePCRN, TRANSFoRm and CuRE projects 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. translating research into clinical practice • Development 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 • To define a “computable” model representationthat supports the entire life-cycle of clinical trials protocol, • To developappropriatetools that use the model representation.

3. 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

4. Learning Healthcare System Safer Clinical Practice • Software • Integration • Interoperability • Services Epidemiological Studies & RCTs Knowledge Translation More research evidence • 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.

5. 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: • a trialist workbench for designing clinical trials • a clinical trials’ management component for conducting and managing clinical research studies. • Tools for translating research into practice

6. ePCRN: US/UK perspective

7. ePCRN Study and eCRF tools Protocol Timeline CRFs Study Database Design Study Collect Data Analyse Data The following provide some example screenshots of the eCRF technology on a current ePCRN prototype

8. Protocol Design

9. Timeline Design

10. eCRF Design

11. Acknowledgments for ePCRN Re-Engineering the Clinical Research Enterprise ePCRN Contract No. HHSN268200425212C

12. knowledge in healthcare • Clinical trials • Controlled populations • Well-defined questions • Distilled scientific findings • Usable in clinical practice • Decision support • EHR systems • Wide coverage • Vast quantity • May lack in detail and quality

13. 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™

14. TRANSFoRmItegrated 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)

15. A screenshot of the vocabulary service web-based interface

16. Exampleeligibilitycriterion • 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

17. Identifying prevalent cases through eligible counts TRANSFoRm Query Workbench Identifying prevalent cases through eligible counts

18. acknowledgments: TRANSFoRmConsortium

19. CURe 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. • Example user interface • for selecting medication • medications use the dictionary of medicines and devices (dm+d).

20. Acknowledgments for CURe

21. realising our imagination: facing challenges "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. Thank you t.arvanitis@warwick.ac.uk