Information technology and informatics enhancement of clinical trial programs

1
Information technology and informatics
enhancement of clinical trial programs
Presented by Matthew Seguin, Director of Clinical
Knowledge Management Capital Technology
Information Services, Inc. Shaw Pittman -
HealthCare Technology Network Meeting Meeting
Topic Technology for Clinical Trials on November
19, 2004 in Washington, DC
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• Material that will be covered today

• CTIS general background information
• Critical parts of a IT enabled Clinical Trial
  Informatics solution
• Integration of lessons learned and industry best
  practice into a customized working solution
• Review of IT enabled ROI in Clinical Trials
  program performance
• Summary
• Questions

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• Capital Technology Information Services, Inc.
  (CTIS)
• Background Information

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• Why was CTIS invited here today?

• CTIS provides information technology and
  informatics support services for the largest
  Clinical Trial Networks in the US and abroad.
• Cancer Therapy Evaluation Program (CTEP)
• Division of AIDS Program (DAIDS)
• Mr. Seguin is the Director of Clinical Knowledge
  Management Systems for CTIS. His principal
  clients are NIHs DAIDS and CTEP programs. He is
  responsible for providing clinical trial 
  informatics and clinical trial management subject
  matter expertise in the development of their
  enterprise-wide information management systems,
  decision support strategies, and good clinical
  practice implementation.

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• CTIS History and Mission

Contribute to.patients well-being.economic
benefits.saving patients lives


1993 to 1998
1985 to 1992
1999 to 2004
1969 to 1984

• Health Informatics
• Clinical Trials Mgmt.
• Data Warehousing
• Enterprise Architecture
• Decision Support Services

• Clinical Informatics
• Information Assurance
• Data Curation
• CTM Consulting
• Customized Enterprise System Development
• Business Intelligence

• IT Services
• IT Integration
• Application Develop
• Industry Consulting

• Information Science
• Communication Plans
• Mgmt Consulting
• Technical Services

• Other Diseases, NIH institutes NHLBI, NIAID
• AMI, CROs, SMOs
• Pharma Companies
• TrialBridge Components

• Cancer, NCI and NIH
• Information for Protocol, Audit, Site,
  Regulations, Sponsor Physician, patients.
• Safety, Efficacy and Efficiency

• Energy, Environment, Health and RD
• Data Management Decision Support
• Intl Development
• Financial Engineering

• Clearinghouse Outreach
• Policy and Strategy Development
• Event Management
• Documentation Publishing

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• Critical parts of a IT enabled Clinical Trial
  Informatics solution

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The most frequently requested Modules for a CRN
Integrated Informatics solution are

• Web enabled Data Warehouses
• An agile and flexible Operational framework
• Evaluation and Implementation framework
• Web enabled Digital Dashboards
• Configurable components
• Electronic Data Capture for patient encounter
  information
• Tools to facilitate tasks such as Protocol
  development and approval

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These Clinical Research management Modules need
to address key business realities or desires

• More INDs and Agents are processed through the CT
  process
• Efficient and effective use of available
  resources
• Open communication practices
• Workflow improvement without re-engineering the
  process
• Reduce resource duplication and enhance
  throughput
• Empower the people to manage change
• Embed quality measures
• Standardized compliance frameworks
• Share information across infrastructures
• Hospitals and resource poor clinics trial
  participation

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These key business realities or desires are
enabled through IT solutions that are highly
efficient and effective

• Rapid exchange of concepts and protocols
• Avoid service fragmentation
• Manage strategic direction implementation
• Facilitate workflow
• Enhance information sharing
• Reuse existing infrastructure
• Enable oversight, monitoring, and measurement
  capabilities
• Dynamic maintenance of Standardized Operating
  Procedures
• Demonstrate a measurable ROI soon after
  implementation

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These solutions will to map to key CT program
objectives and will help drive Informatics
solution

• Many Clinical Trial Informatics driven programs
  have 12 objectives, which are
• Optimization of the clinical research process
• Building of awareness and outreach
• Capacity building and training
• Information flow and management processes
• Resource allocation and optimization
• Regulatory compliance
• Standards management
• Safety management and reporting
• Oversight and monitoring framework
• SOP framework
• Interface with Support organizations
• Stable and Standardized IT infrastructure
  backbone

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• Integration of lessons learned and industry best
  practice into a customized working solution

National Cancer Institute, Cancer Therapy and
Evaluation Program and National Institute of
Allergy and Infectious Disease, Division of AIDS
Program
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Informatics experts work with Clinical Trial
professionals to baseline business requirements
Protocol
TRIAL DESIGN
Trial Plan
Administration
ICFs
Regulations Standards
CRFs
TRIAL SETUP
Trial Design
Trial Data Definition
Global Library
Patient CRFs
Dictionaries Coding
SAEs
TRIAL CONDUCT
SOAP/ DISCO
Tracking
Lab System
ImageWorkflow Data Capture
Validation/Derivation Rules
XML
Data Collection
Data Validation
TRIAL ANALYSIS
Electronic Data
Laboratories
Snapshots
Monitoring
Reporting
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Implement IT industry best practices into each
informatics solution
developing better ways to diagnose, treat and
prevent the many infectious, immunologic and
allergic diseases
Web
Web
Client
Business Rules
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Current IT implemented Informatics solutions are
assessed aligned with CIOs strategic plan
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Devise Informatics solutions that empower
Clinical Trial and Program Management
professionals
How many grade III or higher SAE's have been
reported in the past year, for subjects enrolled
in clinical trials of anti-retroviral drugs in
the US vs. Sub-Saharan Africa, what were they and
how were they distributed by SAE type and across
gender and race? 
Output in Multiple output formats
CTRM - Enterprise Database
011011001100
Aligned with CIO strategic plan
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• Review of IT enabled ROI in Clinical Trials
  Performance

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Cancer Therapy Evaluation Program (CTEP)
Informatics driven - Performance History
Performance element
2003
1999
Five years
Number of IND - Annual
172
117
47
Number of agents - Annual
950
734
29
Level 1
38
Number of patients - Annual
567,854
290,472
95
Number of drug orders - Annual
55,197
26,837
106
Number of treatment courses - Annual
18,658
4,262
338
Level 2
180
Number of active organizations (sites) - Annual
7,717
4,297
80
Number of active investigators - Annual
12,822
10,641
20
Number of protocol increases - Annual
8,308
2,500
232
Number of adverse events reported - Annual
5,000
2,960
69
Level 3
100
Processing time from LOI to protocol
activation-days
240
550
56
Time to submit FDA annual report-days
40
120
67
Level 4
62
Time from when AE occurred to Reported-days
67
130
48
Clinical data upload time-days
10
45
78
Level 5
63
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• Summary

• Customized IT CT systems can help professionals
  manage change
• Identification business process restrictions
  opens up IT options
• Work in partnership to target problem areas and
  devise solutions
• Align current systems with CIO strategic plan
• Implement proven applicable Industry Best
  Practice solutions
• Link business process vital signs to Digital
  Dashboards
• Implement modular configurable components
• Create and standardize interoperable enterprise
  IT architecture
• Guarantee data accuracy throughout a secure chain
  of custody

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• CTIS Contact Information

• Chris Stathes
• Executive Vice President
• One Research Court Suite 200
• Rockville, MD 20850
• Office [phone]

• Matthew Seguin
• Director of Clinical Knowledge Management
• One Research Court Suite 200
• Rockville, MD 20850
• Office [phone]

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• Questions