1. Secure Federated Data Retrieval in Clinical Trials 4 th July 2006 IASTED Telehealth Conference, Banff, Alberta University of Glasgow, Scotland, UK Anthony Stell, Richard Sinnott, Oluwafemi Ajayi

2. The next 15 minutes (+ 5)… Background The Grid Clinical Trials The VOTES Project Challenges Security Anonymisation VOTES Architecture Technology Future Work Demonstration

3. The Grid No single “Grid” (yet)… Common paradigm used is that of a “Virtual Organisation” (VO) A transient collection of resources and entities grouped to achieve a common goal IT resources managed in a Grid: Infrastructure Grid  Using hardware/software to provision services Application Grid  Service oriented architecture Information Grid  The meanings inherent in all different types of data used to conduct business

4. National e-Science Centre Primarily based in Scotland but with large influence in e-Science throughout the UK At Glasgow we have expertise in coding grid applications in applied fields (e.g. bioinformatics) Glasgow Edinburgh

5. Clinical Trials Improve quality of life by researching drugs and treatments for medical conditions Plethora of data across many domains Local, Regional, National, etc. Useful to bring this data together Statistical analysis and identification of trends Harnessing useful information for the process of recruitment Give a better understanding of the large-scale trial processes and systems

6. VOTES Virtual Organisations for Trials and Epidemiological Studies 3 year (£2.8 million) MRC funded project started in October 2005 Strong links with UK Biobank project (http://www.biobank.ac.uk)http://www.biobank.ac.uk Collaboration between various UK universities: Glasgow, Oxford, Nottingham/Leicester, Manchester, Imperial College London

7. VOTES Plan to develop framework for producing Grid infrastructures that address key components of clinical trial / observational study: Patient Recruitment  How many men aged between 45 and 65 had a heart attack last year? How many of them would be willing to participate in the trial of a new drug? Data Collection  Are the participants taking their drug/placebo on a regular basis? Have there been any incidents relating to the trial? Study Management  Who can see the trial data (e.g. consultants, nurses)? Who ensures the trial is in the patient’s interest? Can we simplify the ethical review process? Scotland, and particularly Glasgow (“The sick man of Europe”), is a good testing ground…

8. Grid Security – “AAA” Authentication Who are you? Public Key Certificates VOTES uses simple username/password (just now) Authorization What are you allowed to do? Various technologies: PERMIS, CAS, VOMS VOTES uses a simple access control matrix Accounting What were you doing on the night of…? No established technology yet. VOTES has rudimentary query caching and counting

9. Clinical Security Statistical Inference The ability to identify an individual by combining two sets of non-identifying data e.g. An unusual condition in a particular postcode Anonymisation Encrypting all identifying data from a record, but still having access to the statistical data A critical requirement in implementing these concepts successfully is the need for a unique identifier that can link data spread across multiple domains…

10. Health-care data in Scotland Community HealthCare Index (CHI) Serves as a “unique” identifier for the Scottish population… NHS Number Another “unique” identifier… Scottish parliamentary initiative to implement CHI nationwide by 6 th June 2006 (or 6/6/6)

11. Health-care data in Scotland A lot of things were supposed to happen on this date, which didn’t: Establishment of the CHI number across Scotland was one of these things…

12. Health-care in Scotland Though the idea is sound, all kinds of issues subvert the uniqueness value of the CHI: Duplicate numbers Numbers assigned to the deceased Patients without numbers assigned Population of Scotland: ~ 6 million Number of CHIs assigned: ~ 8 million

13. Anonymisation Mandatory to establish security… Assuming a common identifier is available, further difficulties are: Agreeing on a common way to anonymise data Trusting the other parties with any de-anonymised data Three solutions suggested in paper: Keep data within your domain Let all your data flow freely between domains Anonymisation Service

14. Third anonymisation solution Anonymisation Service Site 1 Site 2 Site 3 User (3) (2) (6) (1) (3) (7) (4,5)

15. Discussion Pros: Can prevent statistical inference before data is returned to requesting site Can set up trust hierarchies analogous to Certificate Authorities (only have to trust the CA, rather than an extended network) Cons: Implementing this dynamically is hard - would need a static Anon. Service that was “always on” Service would need to be aware of transient nature of VOs Haven’t dealt with live data yet – issues will arise that we haven’t though of yet

16. VOTES: Architecture

17. VOTES: Implementation Technologies GridSphere (2.1) Globus Toolkit (4.0) OGSA-DAI (2.2) Security Framework Database user management (Resource-level) Access Control matrix (VO-level) Data sets (all dummy sets just now) SCI Store (Scottish Care Information) GPASS (General Practitioner’s Software) Scottish Medical Records (SMR)

18. To-Do list… Further resilience Multiple portal, grid and data servers Database connectivity testing Uninterrupted service provision Development of recruitment portal: To reproduce the recruitment procedures currently used by clinicians in Scotland, but in electronic format Development of administrative portal: To manage security and data classification on progressively larger scales To provide scaleable VO management Visual demonstration of patient records E.g. X-rays of David Beckham or Wayne Rooney’s metatarsal

19. Futures Follow-up work Scottish Family Health Study Increasingly integrated collaboration with Information Services Division Global Vision Eventually hope this will turn into a global solution First step is to integrate south of the border Unified Data Structure HL7, SNOMED-CT, or maybe something else…?

20. Further Information NeSC Website: http://www.nesc.ac.ukhttp://www.nesc.ac.uk VOTES Website: http://www.nesc.ac.uk/hub/projects/votes http://www.nesc.ac.uk/hub/projects/votes Portal: http://labpc-12.nesc.gla.ac.uk:18080/gridspherehttp://labpc-12.nesc.gla.ac.uk:18080/gridsphere Contact: Prof. Richard Sinnott – r.sinnott@nesc.gla.ac.ukr.sinnott@nesc.gla.ac.uk Anthony Stell – a.stell@nesc.gla.ac.uka.stell@nesc.gla.ac.uk Oluwafemi Ajayi – o.ajayi@nesc.gla.ac.uko.ajayi@nesc.gla.ac.uk

21. “Live” demonstration…