1. SAMSI Career Panel Kevin Anstrom May 24, 2005

2. Educational Background n Cornell University – studied applied statistics with focus on biology and agriculture

3. Educational Background n University of North Carolina at Chapel Hill – studied biostatistics with focus on public health

4. Educational Background n North Carolina State University – studied statistics with focus on biostatistics

5. Employment Background n Duke Clinical Research Institute n Duke University Medical Center n Procter and Gamble Pharmaceuticals n University of Washington – Department of Neurosurgery n National Institute of Environmental Health Science n Duke Clinical Research Institute n Duke University Medical Center n Procter and Gamble Pharmaceuticals n University of Washington – Department of Neurosurgery n National Institute of Environmental Health Science

6. Duke Clinical Research Institute Overview History of the DCRI 1969Founding of the Duke Databank for Cardiovascular Diseases 1970sDecade of observational research 1980sCoordination of multicenter clinical trials Outcomes research pioneered 1990sExtensive multicenter trials experience Landmark outcomes studies Expansion to new therapeutic areas Collaboration with professional societies 1969Founding of the Duke Databank for Cardiovascular Diseases 1970sDecade of observational research 1980sCoordination of multicenter clinical trials Outcomes research pioneered 1990sExtensive multicenter trials experience Landmark outcomes studies Expansion to new therapeutic areas Collaboration with professional societies

7. DCRI: An Academic Research Organization What is an ARO? n An academically based organization dedicated to: l Providing a full range of clinical research services in compliance with worldwide regulatory standards l Providing scientific leadership in the conduct of clinical research l Advancing clinical research methodology l Disseminating new knowledge throughout the global medical community l Educating future generations of clinical researchers What is an ARO? n An academically based organization dedicated to: l Providing a full range of clinical research services in compliance with worldwide regulatory standards l Providing scientific leadership in the conduct of clinical research l Advancing clinical research methodology l Disseminating new knowledge throughout the global medical community l Educating future generations of clinical researchers

8. Where is the DCRI today? n Over 840 faculty and staff n 1,756 manuscripts published since 1996 n Over 250 completed clinical trials and outcomes research studies n Over 506,000 patients enrolled in 60 countries n Over 110 clinical trials currently underway n Trials conducted in over 20 therapeutic areas n Over 840 faculty and staff n 1,756 manuscripts published since 1996 n Over 250 completed clinical trials and outcomes research studies n Over 506,000 patients enrolled in 60 countries n Over 110 clinical trials currently underway n Trials conducted in over 20 therapeutic areas

9. DCRI Functional Groups n Clinical Trial Operations l Project leadership l Communications l Statistics l Data management l Site management and clinical monitoring l Safety surveillance l Regulatory services n Clinical Trial Operations l Project leadership l Communications l Statistics l Data management l Site management and clinical monitoring l Safety surveillance l Regulatory services n Infrastructure Support l Business development l Contracts l Finance l Human resources l Information technology l Quality assurance

10. Global Reach October 2002 United States Canada Mexico Guatemala El Salvador Panama Dominica Venezuela Columbia Brazil Paraguay Argentina Chile Uruguay U.K. Ireland France Spain Portugal Netherlands Belgium Germany Denmark Norway IcelandFinland Poland Czech Rep. Switz. AustriaSlovenia Italy Hungary Romania Bulgaria Greece Ukraine Turkey Israel Estonia Latvia Lithuania Georgia United Arab Emirates India China Thailand Malaysia Singapore Indonesia Hong Kong Australia New Zealand South Africa Taiwan Japan Russia Egypt Duke Clinical Research Institute Overview n Trials conducted in 60 countries

11. Concept Outcomes Clinical Trials Guidelines Performance Indicators Performance Indicators PerformancePerformance The Cycle of Clinical Therapeutics—New Model EducationandFeedbackEducationandFeedback

12. Project Team Composition n Principal investigator n Co-investigators n Project leader n Statistician/statistical programmer n Site coordinator/monitor n Clinical data specialist/data assistant n Programmer n Communications staff n Contracts staff n Principal investigator n Co-investigators n Project leader n Statistician/statistical programmer n Site coordinator/monitor n Clinical data specialist/data assistant n Programmer n Communications staff n Contracts staff

13. Functional Interactions SiteManagementSiteManagement ProjectLeadershipProjectLeadership StatisticsStatistics DataManagementDataManagement Safety Desk & CEC Safety Desk & CEC IVRS/RandomizationIVRS/Randomization ClinicalSuppliesClinicalSupplies CommunicationsCommunications SponsorSponsor InvestigatorsInvestigators

14. Project A Project B Project C Project Level Matrix Site Mgmt Data Mgmt CommStatsIT Project- Oriented Teams managed by Project Leaders Project- Oriented Teams managed by Project Leaders Functional Groups provide services to Project Teams; managed by Directors Functional Groups provide services to Project Teams; managed by Directors Dual Reporting Structure

15. Example … Group of Investigators n Principal Investigator – Kevin Anstrom (Stats) n Statistical Investigator – James Rochon (Biostats) n Clinical Investigator – Mark Steele (Pulmonary Medicine) n Clinical Investigator – Neil MacIntyre (Pulmonary Medicine) n Health Outcomes Investigator– Eric Eisenstein (Doctor of BA) n Principal Investigator – Kevin Anstrom (Stats) n Statistical Investigator – James Rochon (Biostats) n Clinical Investigator – Mark Steele (Pulmonary Medicine) n Clinical Investigator – Neil MacIntyre (Pulmonary Medicine) n Health Outcomes Investigator– Eric Eisenstein (Doctor of BA)

16. Example … Functions of a Coordinating Center n Study coordination and planning n Data management, site management, and reporting activities n Trial design and protocol development n Data analysis n Publication and dissemination of results n Study coordination and planning n Data management, site management, and reporting activities n Trial design and protocol development n Data analysis n Publication and dissemination of results

17. Data Management, Site Management, and Reporting Activities n Establish and follow a strict MOP n Provide training and certification for study personnel n Coordinate subcontracting n Provide timely reports to DSMB, NHLBI, and CCs n Data archival n Establish and follow a strict MOP n Provide training and certification for study personnel n Coordinate subcontracting n Provide timely reports to DSMB, NHLBI, and CCs n Data archival

18. Trial Design and Protocol Development n Assist with Protocol Committees to develop clinically important studies n Provide leadership for data management and statistical design n Employ standardization across network protocols n Coordinate packaging and preparation of study drugs n Assist with Protocol Committees to develop clinically important studies n Provide leadership for data management and statistical design n Employ standardization across network protocols n Coordinate packaging and preparation of study drugs

19. Statistical Design and Analysis n Provide detailed sample size and power calculations n Develop and implement randomization schemes n Develop statistical analysis plans n Conduct analyses for abstracts, manuscripts, and DSMB meetings n Assist in manuscript preparation n Provide detailed sample size and power calculations n Develop and implement randomization schemes n Develop statistical analysis plans n Conduct analyses for abstracts, manuscripts, and DSMB meetings n Assist in manuscript preparation

20. Power and Sample Size Calculations

21. Publication and Dissemination of Results n Work with Steering Committee and CCs to communicate results n Provide editorial support for all IPF publications n IPF Web Site, peer-reviewed publications, national meetings n Link with pulmonary fibrosis foundations and other relevant medical / interest groups n Work with Steering Committee and CCs to communicate results n Provide editorial support for all IPF publications n IPF Web Site, peer-reviewed publications, national meetings n Link with pulmonary fibrosis foundations and other relevant medical / interest groups

22. Questions and Discussion