University of Glasgow, Scotland, UK Anthony Stell, Richard Sinnott, Oluwafemi Ajayi

1. Supporting the Clinical Trial Recruitment Process through the Grid19th September 20065th UK e-Science All-Hands Meeting University of Glasgow, Scotland, UK Anthony Stell, Richard Sinnott, Oluwafemi Ajayi

2. Overview • Background • Clinical trials • VOTES • Challenges • Current practices, applications and workflows • Security requirements • VOTES Implementation • The Grid part • The Clinical part • Future Plans • Demonstration (depending on time)

3. Clinical Trials • Improve quality of life by researching drugs and treatments for medical conditions • Plethora of data across many domains • Local, Regional, National, etc. • Efficient trial recruitment requires advanced ways to target potential subjects • Even with these advanced techniques, a high volume of petitions must be made to achieve correspondingly high recruitment numbers

4. VOTES • Virtual Organisations for Trials and Epidemiological Studies • 3 year (£2.8 million) MRC funded project started in October 2005 • Collaboration between various UK universities: • Glasgow, Oxford, Nottingham/Leicester, Manchester, Imperial College London • Focuses on three key areas of clinical trials: • Patient Recuitment • Data Collection • Study Management

5. The three key areas… • 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?

6. Patient Recruitment Workflow

7. Current Practices • A lot of paper... • Data is entered manually, leading to high error incidence. • Communications are largely paper-based, giving high delay times as documents are passed back and forth. • Biobank (http://www.biobank.ac.uk) is attempting to recruit 500,000 participants between the ages of 40 and 69. Paper-based systems simply won’t cut it for these kinds of numbers…

8. Current Data & Applications • GPASS • General Practice and Administration Software for Scotland • Used mainly in primary care – GPs etc. • SCI Store • National repository for electronic health records • However, regional variations exist (~18 just now) • Scottish Morbidity Records • Provides information on all hospital admissions throughout Scotland

9. GPASS

10. Clinical Security Requirements • Sensitivity • The importance and privacy level applied to a data field within a health record. • “Anonymisation”, Statistical Inference • Consent • The fundamental requirement of asking a patient whether they will allow their information to be used in this trial and what limits are to be set on that use. • HCP Speciality • The many different types of HCP that exist – this affects access to records sensitive to a specific field • “Broken Glass” scenario • All additional to the traditional “AAA” security requirements…

11. The Grid part: Architecture

12. The Grid part: Implementation • Technologies • GridSphere (2.1) • Globus Toolkit (4.0) • OGSA-DAI (2.2) • Security Framework • Database user management (Resource-level) • Local restrictions on local resources • Access Control matrix (VO-level) • A bit-wise privilege matrix that will be available to the whole VO

13. The Clinical part… • Collaborating with the Robertson Centre for Biostatistics at Glasgow University. • Provide front-end web applications specifically tailored for recruitment to clinical trials. • Their web services communicate with the Grid infrastructure shown on the previous page.

14. How does this help? • Current paper-based communication between actors in a trial is replaced by electronic systems • A user-friendly interface familiar to clinicians making efficient use of distributed resources • Increased reliability from failed over components • Flexible and dynamic access to previously inaccessible data sets • Fine-grained limitation to data sets depending on trial role • Increased collaboration between participating institutions

15. To-Do/Done 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 • Ties in with GLASS project (A “Shibbolized” version of the VOTES portal) 

16. Futures • Follow-up work • Increasingly integrated collaboration with Information Services Division of NHS-Scotland • Scottish Family Health Study • Researching genetic databases, the health data therein, with particular emphasis on hereditary conditions • PERISCOPE • To provide a production level e-Research infrastructure for Scottish clinical data • Global Vision • Eventually hope this will turn into a global solution • First step is to integrate south of the border with other nodes of the VOTES project

17. Further Information • Website: http://www.nesc.ac.uk/hub/projects/votes • Portal: http://labpc-12.nesc.gla.ac.uk:18080/gridsphere • Contact: • Prof. Richard Sinnott – r.sinnott@nesc.gla.ac.uk • Anthony Stell – a.stell@nesc.gla.ac.uk • Oluwafemi Ajayi – o.ajayi@nesc.gla.ac.uk

18. “Live” demonstration…