NCRN Data Systems for Clinical Trials

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NCRN Data Systems for Clinical Trials
Monica Jones Information Systems (IS)
Manager 0113 39 27549 m.jones_at_ncrn.org.uk
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Database(s) of Cancer Trials Trials Portfolio
Accrual Databases
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NCRN Trials Portfolio Database - Data Flows
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NCRN Trials Portfolio Database - Functions

• Information on the NCRN Portfolio of Trials
• Trials funded by CRUK, DoH, LRF or MRC, or
  approved by CTAAC.
• Well-designed trials, peer reviewed, large phase
  II/phase III, comprehensive coverage
• Networks derive local portfolios from national
  portfolio
• Collate Accrual figures
• NCRN Key performance indicator
• National and local performance management

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NCRN Trials Portfolio Database - Accrual

• To provide a single point of access to
  information on patient accrual into NCRN
  Portfolio Trials (including Adopted).
• Simplifies data flows between NCRN constituent
  organisations (Networks CTUs)
• Fosters standardisation of accrual data
• Powerful performance management tool at both
  network and national level.
• Measure of NCRN effectiveness
• Identification of Trials or Networks recruiting
  well/poorly
• Predictor of trends in Trials accrual

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Cancer site priority areas for all 34 Cancer
Research Networks
   
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National accrual into NCRN portfolio trials as a
percentage of cancer incidence
   
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NCRN Accrual by Network 2002/3and 2003/4

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 Accrual into NCRN portfolio trials in Cancer
Centres compared with Cancer Units
Number of Patients Recruited
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• Electronic Remote Data Capture (eRDC) Programme

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• The completed CRF is sent to the trials unit by
  post

• The form is date stamped and verified to check
  the information is valid and complete

• The information is entered onto the database via
  the computer

• The information on the computer is checked
  against the paper CRF

• Missing, and invalid data fields are returned to
  the researcher for chasing up

Trials Unit
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• Data is entered at source, into the system
  through a web browser

• This can be checked in real-time by the Trial
  Coordinator

• Messaging enables data chasing to be done quickly
  and cheaply

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eRDC Stage 1 Pilot Project

• Proof of Concept
• Functional Evaluation
• Hardware Software Requirements
• Data Transfer
• Access via Mobile / Wireless devices
• Benchmarking
• Recommendations

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Benefits of eRDC

• Cut the time involved in Case Report Form (CRF)
  authoring, database development and protocol
  launch
• Use of data validation to minimise data
  discrepancies and data queries
• Reduction in need for data entry, postage and
  storage of paper CRFs
• Better use of highly qualified computer
  programmers
• Reduce time to data locking and number of
  monitoring visits required
• Data available in real time for interim analysis
  and review
• Maintenance of a full audit trail
• Transfer risk and demonstrate value for money
  by utilising a secure hosted service managed by a
  proven commercial partner

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Proof of Concept
Study design
CTRU University of Leeds
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(No Transcript)
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Functional Evaluation
CTRU (Leeds)
NCRN CC (Leeds)
Experiences from proof of concept
RDC Functionality, Adherence to Legislation
(ICH GCP, EU Directive)
CDMS Functional Requirements
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Assessed Functionality

• Study Definition
• Remote Data Entry
• Discrepancy Management
• Reusable Component Library
• System Administration

Demonstrated Functionality

• Randomisation
• Batch loading
• Reporting
• Import / Export
• Source Data Verification
• Thesaurus Management

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Feedback from Users

• Access / Usability issues from Research Nurses
• Logging On / Set-up Easy
• Using the System Easy
• Resolving Discrepancies Easy / Medium
• Experience with OC_RDC Medium (For Reasons of
  Familiarly and Frequency of Use)
• Access to computers Difficult in majority of
  cases
• Technical / Usability Issues from Study
  Developers
• Logging on/Set up Easy
• Study Development Difficult
• Handling Data Medium
• Connectivity Quick
• GUI Functionality Navigation poor, Skipping
  painful
• Comparison with other products - Worse

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Benchmarking
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Conclusions Recommendations

• Proved eRDC can work in NCRN structure
• Managed Service via Secure Application Block
  (SAB) satisfies security and DPA requirements
  encrypted data transfer via NHSNet (N3)
• Zero client required for deployment to remote or
  portable input devices. Must be entirely
  web-enabled
• Proceed with a Stage II Pilot to provide
  scalability across multi-centre / multi-trials
  and demonstrate full benefits of eRDC via
  measurable outcomes
• Demonstrate open architecture / platform
  independent application / use of data
  standardisation and dictionaries

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Stage 2 eRDC Pilot

• Multi-Centre (30)
• Multi-Unit (6)
• Multi-Trial (8)
• including
• early phase trial whole eCRFs flexibility
• Non-oncology to demonstrate generic applicability
• Mixed Modality (Chemotherapy, Radiotherapy,
  Surgical)
• 2/3 New trials 5/6 existing trials cover
  whole trial life events
• UK-Wide trials to reflect maturing organisation

Scalability
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Preferred eRDC Application
Single Platform solution for full lifecycle
design, development, testing and execution of
clinical trials operated entirely through a thin
browser internet / Intranet connection. Ensures
stability, security and extensibility of the
system and allows leveraging technologies such as
XML and Web Services natively.
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Issues to be aware of

• Any national system will have to link to NPfIT
  programme (including accreditation process) so
  need to design in links
• Relying on access to NHSNet / N3 and H/W so need
  to have an easily deployable system
• Interoperability with existing systems i.e.
  randomisation
• Opportunity to demonstrate data standardisation
  (need appropriate funding from beginning)
• Need to establish principles and processes of
  electronic remote data capture across the NCRN
  without getting hung up on one particular
  application / data hosting solution
• Must have measurable outcomes (defined up front)
  to have a genuine set of metrics to compare with
  other possible solutions

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NCRN / CancerGRID Collaboration

• WP 4 (from Apr 06) will consist of
• Assessment of CancerGRID deliverables in
  particular the suitability for deployment across
  the NCRN
• A demonstration that the existing trials
  databases, including those captured
  electronically (eRDC), can be integrated using
  e-Science / GRID technology with appropriate
  confidential and protected databases within which
  analysis may be carried out
• If suitable the creation of virtual generic
  national cancer clinical trials system based
  around these systems (merging of projects)

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• Any
• Questions ?