SAMSI Career Panel
Kevin Anstrom
May 24, 2005
Educational Background

Cornell University – studied applied statistics
with focus on biology and agriculture
Educational Background
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University of North Carolina at Chapel Hill –
studied biostatistics with focus on public health
Educational Background

North Carolina State University – studied
statistics with focus on biostatistics
Employment Background
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Duke Clinical Research Institute
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Duke University Medical Center
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Procter and Gamble Pharmaceuticals
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University of Washington – Department of
Neurosurgery

National Institute of Environmental Health
Science
Duke Clinical Research Institute Overview
History of the DCRI
1969
Founding of the Duke Databank for
Cardiovascular Diseases
1970s
Decade of observational research
1980s
Coordination of multicenter clinical trials
Outcomes research pioneered
1990s
Extensive multicenter trials experience
Landmark outcomes studies
Expansion to new therapeutic areas
Collaboration with professional societies
DCRI: An Academic Research Organization
What is an ARO?
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An academically based organization dedicated to:
 Providing a full range of clinical research services in
compliance with worldwide regulatory standards
 Providing scientific leadership in the conduct of
clinical research
 Advancing clinical research methodology
 Disseminating new knowledge throughout the global
medical community
 Educating future generations of clinical researchers
Where is the DCRI today?
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Over 840 faculty and staff
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1,756 manuscripts published since 1996
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Over 250 completed clinical trials and outcomes
research studies
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Over 506,000 patients enrolled in 60 countries
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Over 110 clinical trials currently underway
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Trials conducted in over 20 therapeutic areas
DCRI Functional Groups
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Clinical Trial Operations
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Project leadership
Communications
Statistics
Data management
Site management and
clinical monitoring
Safety surveillance
Regulatory services
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Infrastructure Support
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Business development
Contracts
Finance
Human resources
Information technology
Quality assurance
Duke Clinical Research Institute Overview
Global Reach
Iceland
Norway Finland
Russia
Estonia
Latvia
U.K. Denmark Lithuania
Netherlands Poland
Ireland
Germany
Belgium
Czech Rep.
Austria Slovenia Ukraine
Switz.
France Hungary Romania
Bulgaria
Georgia
Spain Italy
Portugal
GreeceTurkey
Canada
United States
Israel
Egypt
United Arab Emirates
Mexico
India
Dominica
Guatemala
Panama
Japan
China
Taiwan
Hong Kong
Thailand
Venezuela
El Salvador
Malaysia
Columbia
Singapore
Indonesia
Brazil
Paraguay
Australia
Chile
Uruguay
South Africa
Argentina
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Trials conducted in 60 countries
New Zealand
October 2002
The Cycle of Clinical Therapeutics—New Model
Concept
Clinical
Trials
Guidelines
Outcomes
Education
and
Feedback
Performance
Indicators
Performance
Project Team Composition
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Principal investigator
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Co-investigators
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Project leader
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Statistician/statistical programmer
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Site coordinator/monitor
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Clinical data specialist/data assistant
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Programmer
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Communications staff
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Contracts staff
Functional Interactions
Communications
IVRS/
Randomization
Sponsor
Site
Management
Investigators
Project
Leadership
Safety Desk
& CEC
Statistics
Data
Management
Clinical
Supplies
Project Level Matrix
Functional Groups
Dual
Reporting
Structure
ProjectOriented
Teams
managed
by Project
Leaders
provide services to Project Teams; managed by Directors
Site
Mgmt
Project
A
Project
B
Project
C
Data
Mgmt
Stats
Comm
IT
Example … Group of Investigators
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Principal Investigator – Kevin Anstrom (Stats)
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Statistical Investigator – James Rochon
(Biostats)
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Clinical Investigator – Mark Steele (Pulmonary
Medicine)
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Clinical Investigator – Neil MacIntyre
(Pulmonary Medicine)
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Health Outcomes Investigator– Eric Eisenstein
(Doctor of BA)
Example … Functions of a Coordinating Center
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Study coordination and planning
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Data management, site management, and
reporting activities
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Trial design and protocol development
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Data analysis
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Publication and dissemination of results
Data Management, Site Management, and
Reporting Activities
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Establish and follow a strict MOP
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Provide training and certification for study
personnel
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Coordinate subcontracting
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Provide timely reports to DSMB, NHLBI, and
CCs
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Data archival
Trial Design and Protocol Development
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Assist with Protocol Committees to develop
clinically important studies
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Provide leadership for data management and
statistical design
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Employ standardization across network
protocols
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Coordinate packaging and preparation of study
drugs
Statistical Design and Analysis
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Provide detailed sample size and power
calculations
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Develop and implement randomization
schemes
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Develop statistical analysis plans
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Conduct analyses for abstracts, manuscripts,
and DSMB meetings
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Assist in manuscript preparation
Power and Sample Size Calculations
1600
Total Sample Size
1400
1200
1000
800
600
400
200
0
0.50
0.55
0.60
0.65
Hazard Ratio
80% Power
90% Power
0.70
Publication and Dissemination of Results
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Work with Steering Committee and CCs to
communicate results
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Provide editorial support for all IPF publications
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IPF Web Site, peer-reviewed publications,
national meetings
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Link with pulmonary fibrosis foundations and
other relevant medical / interest groups
Questions and Discussion