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 CTIS – Capital Technology Information Services, Inc. Proprietary Information

2. 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

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

4. 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. Why was CTIS invited here today?

5. Contribute to….patients’ well-being….economic benefits….saving patients’ lives CTIS’ History and Mission 1985 to 1992 1993 to 1998 1969 to 1984 1999 to 2004 • Health Informatics • Clinical Trials Mgmt. • Data Warehousing • Enterprise Architecture • Decision Support Services • Information Science • Communication Plans • Mgmt Consulting • Technical Services • IT Services • IT Integration • Application Develop • Industry Consulting • Clinical Informatics • Information Assurance • Data Curation • CTM Consulting • Customized Enterprise System Development • Business Intelligence • Clearinghouse & Outreach • Policy and Strategy Development • Event Management • Documentation & Publishing • Energy, Environment, Health and R&D • Data Management & Decision Support • Int’l Development • Financial Engineering • Cancer, NCI and NIH • Information for Protocol, Audit, Site, Regulations, Sponsor Physician, patients. • Safety, Efficacy and Efficiency • Other Diseases, NIH institutes: NHLBI, NIAID • AMI, CROs, SMOs • Pharma Companies • TrialBridge Components

6. Critical parts of a IT enabled Clinical Trial Informatics solution

7. 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

8. 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

9. 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

10. 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 withSupport organizations • Stable and Standardized IT infrastructure backbone

11. 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

12. 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 Reporting Monitoring

13. Dataset Definitions CTRM Workflow CTRM Enterprise Models Database Design Software Modules 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

14. Accrual AER Treatment Grants 1001 1101 0010 1001 1101 0010 1001 1101 0010 1001 1101 0010 Clinical Data System AdEERS Outcomes System Grants Management CTRM - Enterprise Database 1001 1101 0010 1001 1101 0010 1001 1101 0010 1001 1101 0010 Drug Repository International Research Publications Database DSMB FDA IRB Current IT implemented Informatics solutions are assessed & aligned with CIO’s strategic plan

15. EIS Query in English Query Analyzer S Q L 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

16. Review of IT enabled ROI in Clinical Trials Performance

17. 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%

18. 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 Summary

19. CTIS Contact Information • Chris Stathes Executive Vice President One Research Court Suite 200 Rockville, MD 20850 Office: (301) 948-3033 • Matthew Seguin Director of Clinical Knowledge Management One Research Court Suite 200 Rockville, MD 20850 Office: (301) 948-3033

20. Questions