SAMSI Career Panel

Kevin Anstrom

SAMSI Career Panel

Kevin Anstrom

May 24, 2005May 24, 2005

Educational Background Educational Background

Cornell University – studied applied statistics with focus on biology and agriculture

Cornell University – studied applied statistics with focus on biology and agriculture

Educational Background Educational Background

University of North Carolina at Chapel Hill – studied biostatistics with focus on public health

University of North Carolina at Chapel Hill – studied biostatistics with focus on public health

Educational Background Educational Background North Carolina State University – studied

statistics with focus on biostatistics

North Carolina State University – studied statistics with focus on biostatistics

Employment Background Employment Background

Duke Clinical Research Institute

Duke University Medical Center

Procter and Gamble Pharmaceuticals

University of Washington – Department of Neurosurgery

National Institute of Environmental Health Science

Duke Clinical Research Institute

Duke University Medical Center

Procter and Gamble Pharmaceuticals

University of Washington – Department of Neurosurgery

National Institute of Environmental Health Science

Duke Clinical Research Institute OverviewHistory of the DCRI

Duke Clinical Research Institute OverviewHistory 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

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 OrganizationDCRI: An Academic Research Organization

What is an ARO?

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

What is an ARO?

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?Where is the DCRI today?

Over 840 faculty and staff

1,756 manuscripts published since 1996

Over 250 completed clinical trials and outcomes research studies

Over 506,000 patients enrolled in 60 countries

Over 110 clinical trials currently underway

Trials conducted in over 20 therapeutic areas

Over 840 faculty and staff

1,756 manuscripts published since 1996

Over 250 completed clinical trials and outcomes research studies

Over 506,000 patients enrolled in 60 countries

Over 110 clinical trials currently underway

Trials conducted in over 20 therapeutic areas

DCRI Functional GroupsDCRI Functional Groups

Clinical Trial Operations Project leadership Communications Statistics Data management Site management and

clinical monitoring Safety surveillance Regulatory services

Clinical Trial Operations Project leadership Communications Statistics Data management Site management and

clinical monitoring Safety surveillance Regulatory services

Infrastructure Support Business development Contracts Finance Human resources Information technology Quality assurance

Infrastructure Support Business development Contracts Finance Human resources Information technology Quality assurance

Global ReachGlobal Reach

October 2002

United States

Canada

Mexico

GuatemalaGuatemala

El Salvador

Panama

Dominica

Venezuela

Columbia

Brazil

Paraguay

Argentina

Chile

Uruguay

U.K.Ireland

France

SpainPortugal

Netherlands

BelgiumGermany

Denmark

NorwayIceland Finland

Poland

Czech Rep.Switz.

Austria Slovenia

Italy

HungaryRomania

Bulgaria

Greece

Ukraine

Turkey

Israel

EstoniaLatvia

Lithuania

Georgia

United Arab EmiratesIndia

China

Thailand

Malaysia

Singapore

Indonesia

Hong Kong

Australia

New Zealand

South Africa

Taiwan

Japan

Russia

EgyptEgypt

Duke Clinical Research Institute OverviewDuke Clinical Research Institute Overview

Trials conducted in 60 countriesTrials conducted in 60 countries

ConceptConcept

OutcomesOutcomes

Clinical Trials

Clinical Trials

GuidelinesGuidelines

PerformanceIndicators

PerformanceIndicators

PerformancePerformancePerformancePerformance

The Cycle of Clinical Therapeutics—New ModelThe Cycle of Clinical Therapeutics—New Model

EducationEducationandand

FeedbackFeedback

EducationEducationandand

FeedbackFeedback

Project Team Composition Project Team Composition

Principal investigator

Co-investigators

Project leader

Statistician/statistical programmer

Site coordinator/monitor

Clinical data specialist/data assistant

Programmer

Communications staff

Contracts staff

Principal investigator

Co-investigators

Project leader

Statistician/statistical programmer

Site coordinator/monitor

Clinical data specialist/data assistant

Programmer

Communications staff

Contracts staff

Functional InteractionsFunctional Interactions

SiteSiteManagementManagement

SiteSiteManagementManagement

Project Project LeadershipLeadership

Project Project LeadershipLeadership

StatisticsStatisticsStatisticsStatistics

DataDataManagementManagement

DataDataManagementManagement

Safety DeskSafety Desk& CEC& CEC

Safety DeskSafety Desk& CEC& CEC

IVRS/IVRS/RandomizationRandomization

IVRS/IVRS/RandomizationRandomization

ClinicalClinicalSuppliesSuppliesClinicalClinical

SuppliesSupplies

CommunicationsCommunicationsCommunicationsCommunications

SponsorSponsorSponsorSponsor

InvestigatorsInvestigatorsInvestigatorsInvestigators

ProjecProject At A

ProjecProject Bt B

ProjecProject Ct C

Project Level Matrix Project Level Matrix

Site Site MgmtMgmt

Data Data MgmtMgmt CommCommStatsStats ITIT

Project-Oriented Teams

managed by Project Leaders

Project-Oriented Teams

managed by Project Leaders

Functional Groupsprovide services to Project Teams; managed by Directors

Functional Groupsprovide services to Project Teams; managed by DirectorsDual

Reporting Structure

Dual Reporting Structure

Example … Group of Investigators Example … Group of Investigators

Principal Investigator – Kevin Anstrom (Stats)

Statistical Investigator – James Rochon (Biostats)

Clinical Investigator – Mark Steele (Pulmonary Medicine)

Clinical Investigator – Neil MacIntyre (Pulmonary Medicine)

Health Outcomes Investigator– Eric Eisenstein (Doctor of BA)

Principal Investigator – Kevin Anstrom (Stats)

Statistical Investigator – James Rochon (Biostats)

Clinical Investigator – Mark Steele (Pulmonary Medicine)

Clinical Investigator – Neil MacIntyre (Pulmonary Medicine)

Health Outcomes Investigator– Eric Eisenstein (Doctor of BA)

Example … Functions of a Coordinating Center Example … Functions of a Coordinating Center

Study coordination and planning

Data management, site management, and reporting activities

Trial design and protocol development

Data analysis

Publication and dissemination of results

Study coordination and planning

Data management, site management, and reporting activities

Trial design and protocol development

Data analysis

Publication and dissemination of results

Data Management, Site Management, and Reporting Activities Data Management, Site Management, and Reporting Activities

Establish and follow a strict MOP

Provide training and certification for study personnel

Coordinate subcontracting

Provide timely reports to DSMB, NHLBI, and CCs

Data archival

Establish and follow a strict MOP

Provide training and certification for study personnel

Coordinate subcontracting

Provide timely reports to DSMB, NHLBI, and CCs

Data archival

Trial Design and Protocol Development Trial Design and Protocol Development

Assist with Protocol Committees to develop clinically important studies

Provide leadership for data management and statistical design

Employ standardization across network protocols

Coordinate packaging and preparation of study drugs

Assist with Protocol Committees to develop clinically important studies

Provide leadership for data management and statistical design

Employ standardization across network protocols

Coordinate packaging and preparation of study drugs

Statistical Design and Analysis Statistical Design and Analysis

Provide detailed sample size and power calculations

Develop and implement randomization schemes

Develop statistical analysis plans

Conduct analyses for abstracts, manuscripts, and DSMB meetings

Assist in manuscript preparation

Provide detailed sample size and power calculations

Develop and implement randomization schemes

Develop statistical analysis plans

Conduct analyses for abstracts, manuscripts, and DSMB meetings

Assist in manuscript preparation

Power and Sample Size Calculations Power and Sample Size Calculations

0

200

400

600

800

1000

1200

1400

1600

0.50 0.55 0.60 0.65 0.70

Hazard Ratio

To

tal

Sam

ple

Siz

e

80% Power 90% Power

Publication and Dissemination of Results Publication and Dissemination of Results

Work with Steering Committee and CCs to communicate results

Provide editorial support for all IPF publications

IPF Web Site, peer-reviewed publications, national meetings

Link with pulmonary fibrosis foundations and other relevant medical / interest groups

Work with Steering Committee and CCs to communicate results

Provide editorial support for all IPF publications

IPF Web Site, peer-reviewed publications, national meetings

Link with pulmonary fibrosis foundations and other relevant medical / interest groups

Questions and Discussion Questions and Discussion