CTIS – Capital Technology Information Services, Inc. Proprietary Information
Information technology and informatics enhancement of
clinical trial programs
Presented byMatthew 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. 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
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
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
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
1969 to
1984
•Information Science •Communication Plans•Mgmt Consulting •Technical Services
• Clearinghouse & Outreach
• Policy and Strategy Development
• Event Management
• Documentation & Publishing
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Critical parts of a IT enabled Clinical Trial Informatics solution
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
The most frequently requested Modules for a CRN Integrated Informatics solution are:
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
These Clinical Research management Modules need to address key business realities or desires
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
These key business realities or desires are enabled through IT solutions that are highly efficient and effective
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
These solutions will to map to key CT program objectives and will help drive Informatics solution
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
Regulations &Standards
Protocol
Electronic Data
CRFs
Patient CRFs
Laboratories
ImageWorkflowData Capture
Dictionaries Coding
Validation/Derivation Rules
TRIAL DESIGN
Trial Plan Administration
TRIAL SETUP
Trial Design
Trial DataDefinition
TRIAL CONDUCT
SOAP/ DISCO
Tracking
TRIAL ANALYSIS
Snapshots Monitoring
GlobalLibrary
DataCollection
DataValidation
Reporting
LabSystemXML
SAEs
ICFs
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Implement IT industry best practices into each informatics solution
developing better ways to diagnose, treat and prevent the many infectious,
immunologic and allergic diseasesDataset
DefinitionsCTRM
Workflow
CTRM Enterprise
Models
BusinessRules
Web
Database DesignSoftware Modules
Client
Web
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Current IT implemented Informatics solutions are assessed & aligned with CIO’s strategic plan
CTRM - Enterprise Database
AdEERSOutcomes
SystemGrants
Management
100111010010
100111010010
100111010010
100111010010
100111010010
ClinicalData System
100111010010
100111010010
100111010010
Accrual AER Treatment Grants
PublicationsDatabase Drug Repository
DSMB FDAIRB
International Research
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Devise Informatics solutions that empower Clinical Trial and Program Management professionals
CTRM - Enterprise Database
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?
Query Analyzer
EIS
011011001100
SQL
Query in English
Output in Multiple output formats
Aligned with CIO strategic plan
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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 2003 1999 Five yearsNumber 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%
CTIS – Capital Technology Information Services, Inc. Proprietary Information
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
CTIS – Capital Technology Information Services, Inc. Proprietary Information
CTIS Contact Information
Matthew Seguin
Director of Clinical Knowledge
Management
One Research Court Suite 200
Rockville, MD 20850
Office: (301) 948-3033
Chris Stathes
Executive Vice President
One Research Court Suite 200
Rockville, MD 20850
Office: (301) 948-3033
CTIS – Capital Technology Information Services, Inc. Proprietary Information
Questions