Transcript Slide 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
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Capital Technology Information
Services, Inc. (CTIS)
Background Information
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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.
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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 NIH’s 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.
CTIS – Capital Technology Information Services, Inc. Proprietary Information
CTIS’ History and Mission
Contribute to….patients’ well-being….economic benefits….saving patients’ lives
1969
to
1984
•Information Science
•Communication Plans
•Mgmt Consulting
•Technical Services
• Clearinghouse &
Outreach
• Policy and Strategy
Development
• Event Management
• Documentation &
Publishing
1985
to
1992
•IT Services
•IT Integration
•Application Develop
•Industry Consulting
• Energy,
Environment,
Health and R&D
• Data Management
& Decision Support
• Int’l Development
• Financial
Engineering
1993
to
1998
•Health Informatics
•Clinical Trials Mgmt.
•Data Warehousing
•Enterprise Architecture
•Decision Support Services
• Cancer, NCI and
NIH
• Information for
Protocol, Audit, Site,
Regulations,
Sponsor Physician,
patients.
• Safety, Efficacy and
Efficiency
CTIS – Capital Technology Information Services, Inc. Proprietary Information
1999
to
2004
•Clinical Informatics
•Information Assurance
•Data Curation
•CTM Consulting
•Customized Enterprise
System Development
•Business Intelligence
• Other Diseases, NIH
institutes: NHLBI,
NIAID
• AMI, CROs, SMOs
• Pharma Companies
• TrialBridge
Components
Critical parts of a IT enabled Clinical
Trial Informatics solution
CTIS – Capital Technology Information Services, Inc. Proprietary Information
The most frequently requested Modules for a CRN
Integrated Informatics solution are:

Web enabled Data Warehouses
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An agile and flexible Operational framework
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Evaluation and Implementation framework
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Web enabled Digital Dashboards

Configurable components

Electronic Data Capture for patient encounter information

Tools to facilitate tasks such as Protocol development and
approval
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
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Open communication practices
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Workflow improvement without re-engineering the process
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Reduce resource duplication and enhance throughput
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Empower the people to manage change
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Embed quality measures

Standardized compliance frameworks

Share information across infrastructures

Hospitals and resource poor clinics trial participation
CTIS – Capital Technology Information Services, Inc. Proprietary Information
These key business realities or desires are enabled
through IT solutions that are highly efficient and
effective

Rapid exchange of concepts and protocols
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Avoid service fragmentation

Manage strategic direction implementation

Facilitate workflow
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Enhance information sharing
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Reuse existing infrastructure
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Enable oversight, monitoring, and measurement capabilities
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Dynamic maintenance of Standardized Operating Procedures

Demonstrate a measurable ROI soon after implementation
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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:
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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
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Informatics experts work with Clinical Trial
professionals to baseline business requirements
Protocol
TRIAL DESIGN
Trial Plan
ICFs
CRFs
Regulations &
Standards
TRIAL SETUP
Trial
Design
Patient
CRFs
SAEs
Image
Workflow
Data
Capture
Administration
XML
Electronic Data
Trial Data
Definition
Global
Library
TRIAL CONDUCT
SOAP/
Tracking
DISCO
Data
Collection
Dictionaries
Coding
Lab
System
Data
Validation
TRIAL ANALYSIS
Snapshots
Reporting
Monitoring
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Validation/
Derivation Rules
Laboratories
Implement IT industry best practices into each
informatics solution
Dataset
Definitions
developing better ways to
diagnose, treat and prevent the many infectious,
immunologic and allergic diseases
CTRM
Workflow
CTRM
Enterprise
Models
Database Design
Business
Rules
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Software Modules
W
e
C b
l
i
e
n
t
W
e
b
Current IT implemented Informatics solutions are
assessed & aligned with CIO’s strategic plan
Accrual
AER
Treatment
1001
1101
0010
1001
1101
0010
1001
1101
0010
AdEERS
Outcomes
System
Clinical
Data System
1001
1101
0010
Publications
Database
1001
1101
0010
Grants
1001
1101
0010
Grants
Management
CTRM - Enterprise Database
Drug Repository
1001
1101
0010
IRB
DSMB
CTIS – Capital Technology Information Services, Inc. Proprietary Information
FDA
1001
1101
0010
International
Research
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?
EIS
Query in English
Output in
Multiple output formats
S
Q
L
Query Analyzer
011011001100
CTRM - Enterprise Database
Aligned with CIO strategic plan
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Review of IT enabled ROI in Clinical Trials
Performance
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Cancer Therapy Evaluation Program (CTEP) Informatics
driven - Performance History
Performance element
Number of IND - Annual
Number of agents - Annual
Level 1
Number of patients - Annual
Number of drug orders - Annual
Number of treatment courses - Annual
Level 2
Number of active organizations (sites) - Annual
Number of active investigators - Annual
Number of protocol increases - Annual
Number of adverse events reported - Annual
Level 3
Processing time from LOI to protocol activation-days
Time to submit FDA annual report-days
Level 4
Time from when AE occurred to Reported-days
Clinical data upload time-days
Level 5
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2003
172
950
567,854
55,197
18,658
7,717
12,822
8,308
5,000
240
40
67
10
1999 Five years
117
47%
734
29%
38%
290,472
95%
26,837
106%
4,262
338%
180%
4,297
80%
10,641
20%
2,500
232%
2,960
69%
100%
550
56%
120
67%
62%
130
48%
45
78%
63%
Summary
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Customized IT CT systems can help professionals manage change
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Identification business process restrictions opens up IT options
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Work in partnership to target problem areas and devise solutions
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Align current systems with CIO strategic plan
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Implement proven & applicable Industry Best Practice solutions
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Link business process vital signs to Digital Dashboards
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Implement modular configurable components
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Create and standardize interoperable enterprise IT architecture
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Guarantee data accuracy throughout a secure chain of custody
CTIS – Capital Technology Information Services, Inc. Proprietary Information
CTIS Contact Information

Matthew Seguin

Chris Stathes
Director of Clinical Knowledge
Executive Vice President
Management
One Research Court Suite 200
One Research Court Suite 200
Rockville, MD 20850
Rockville, MD 20850
Office: (301) 948-3033
Office: (301) 948-3033
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Questions
CTIS – Capital Technology Information Services, Inc. Proprietary Information