Supporting the Clinical Trial Recruitment Process through the Grid 19 th September 2006 5 th UK...
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Supporting the Clinical Trial Recruitment Process through the Grid 19 th September 2006 5 th UK e-Science All-Hands Meeting University of Glasgow, Scotland, UK Anthony Stell, Richard Sinnott, Oluwafemi Ajayi
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Transcript of Supporting the Clinical Trial Recruitment Process through the Grid 19 th September 2006 5 th UK...
Supporting the Clinical Trial Recruitment Process through the Grid
19th September 20065th UK e-Science All-Hands Meeting
University of Glasgow, Scotland, UKAnthony Stell, Richard Sinnott,
Oluwafemi Ajayi
Overview
BackgroundClinical trialsVOTES
ChallengesCurrent practices, applications and workflowsSecurity requirements
VOTES ImplementationThe Grid partThe Clinical partFuture Plans
Demonstration (depending on time)
Clinical Trials
Improve quality of life by researching drugs and treatments for medical conditionsPlethora of data across many domains
Local, Regional, National, etc.
Efficient trial recruitment requires advanced ways to target potential subjectsEven with these advanced techniques, a high volume of petitions must be made to achieve correspondingly high recruitment numbers
VOTES
Virtual Organisations for Trials and Epidemiological Studies3 year (£2.8 million) MRC funded project started in October 2005Collaboration between various UK universities:
Glasgow, Oxford, Nottingham/Leicester, Manchester, Imperial College London
Focuses on three key areas of clinical trials:Patient RecuitmentData CollectionStudy Management
The three key areas…
Patient RecruitmentHow 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 CollectionAre the participants taking their drug/placebo on a regular basis? Have there been any incidents relating to the trial?
Study ManagementWho 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?
Patient Recruitment Workflow
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…
Current Data & Applications
GPASSGeneral Practice and Administration Software for ScotlandUsed mainly in primary care – GPs etc.
SCI StoreNational repository for electronic health recordsHowever, regional variations exist (~18 just now)
Scottish Morbidity RecordsProvides information on all hospital admissions throughout Scotland
GPASS
Clinical Security Requirements
SensitivityThe importance and privacy level applied to a data field within a health record.“Anonymisation”, Statistical Inference
ConsentThe 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 SpecialityThe 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…
The Grid part: Architecture
OGSA-DAIService
GlobusContainer
PortalGrid Server Data Server
DrivingDB
SCI Store 2(SQL Server)
SCI Store 1(SQL Server)
Consent DB(Oracle 10g)
RCB Test Trials DB
(SQL Server)
User Authentication
GlasgowOther
Transfer Grid
Nodes
Remote Trust Policies
AuthorisationAccess Matrix Security Policies
Access Security Policies
Local Trust
Policies
Local Trust
Policies
Local Trust
Policies
OGSA-DAIService
GlobusContainer
Grid Server Data Server
DrivingDB
SCI Store 2(SQL Server)
SCI Store 1(SQL Server)
Consent DB(Oracle 10g)
RCB Test Trials DB
(SQL Server)
GlasgowOther
Transfer Grid
Nodes
Remote Trust Policies
AuthorisationAccess Matrix Security Policies
Access Security Policies
Access Security Policies
Local Trust
Policies
Local Trust
Policies
Local Trust
Policies
GPASS
Local Trust
Policies
Local Trust
Policies
OGSA-DAIService
GlobusContainer
PortalGrid Server Data Server
DrivingDB
SCI Store 2(SQL Server)
SCI Store 1(SQL Server)
Consent DB(Oracle 10g)
RCB Test Trials DB
(SQL Server)
User Authentication
GlasgowOther
Transfer Grid
Nodes
Remote Trust Policies
AuthorisationAccess Matrix Security Policies
Access Security Policies
Local Trust
Policies
Local Trust
Policies
Local Trust
Policies
OGSA-DAIService
GlobusContainer
Grid Server Data Server
DrivingDB
SCI Store 2(SQL Server)
SCI Store 1(SQL Server)
Consent DB(Oracle 10g)
RCB Test Trials DB
(SQL Server)
GlasgowOther
Transfer Grid
Nodes
Remote Trust Policies
AuthorisationAccess Matrix Security Policies
Access Security Policies
Access Security Policies
Local Trust
Policies
Local Trust
Policies
Local Trust
Policies
GPASS
Local Trust
Policies
Local Trust
Policies
The Grid part: Implementation
TechnologiesGridSphere (2.1)Globus Toolkit (4.0)OGSA-DAI (2.2)
Security FrameworkDatabase 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
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.
How does this help?
Current paper-based communication between actors in a trial is replaced by electronic systemsA user-friendly interface familiar to clinicians making efficient use of distributed resourcesIncreased reliability from failed over componentsFlexible and dynamic access to previously inaccessible data setsFine-grained limitation to data sets depending on trial roleIncreased collaboration between participating institutions
To-Do/Done list…
Further resilience:Multiple portal, grid and data serversDatabase connectivity testingUninterrupted 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 scalesTo provide scaleable VO management
Visual demonstration of patient records:E.g. X-rays of David Beckham or Wayne Rooney’s metatarsalTies in with GLASS project (A “Shibbolized” version of the VOTES portal)
Futures
Follow-up workIncreasingly integrated collaboration with Information Services Division of NHS-ScotlandScottish 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 VisionEventually hope this will turn into a global solutionFirst step is to integrate south of the border with other nodes of the VOTES project
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 – [email protected] Stell – [email protected] Ajayi – [email protected]
“Live” demonstration…
