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Standardized Data Collection for Cardiovascular Trials

September 11, 2009


(to view a presentation, click the title below)

9:00AM - Welcome and Introduction
Karen A. Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products (DCRP), CDER

9:05AM - An Overview of the December 2008 Diabetes Cardiovascular Guidance
Hylton Joffee, MD, MMSc
Lead Medical Officer, Diabetes Drug Group I, Division of Metabolism and Endocrinology Products (DMEP), CDER

9:10AM - FDA Study Data Standards: Current Status
Johnathan G. Levine, PhD
Senior Scientific Policy Analyst, FDA
Office of the Commissioner / Office of Critical Path Programs

9:25AM - NIH Roadmap Projects for Therapeutic Data Standards: Case Studies in Tuberculosis & Acute Coronary Syndrome
Bron Kisler
CDISC - Senior Director, Terminology & Technical Strategy

9:40AM - HL7
Charles Jaffee, MD
CEO, Health Level 7, Inc.

9:55AM - Critical Path Perspective on Collaborations to Support Data Standards
Leonard Sacks, MD
Deputy Director, Office of Critical Path Programs, FDA

10:00AM - Clinical Trials Transformation Initiative
Judith M. Kramer, MD, MS
Associate Professor of Medicine, Duke University Medical Center; Executive Director, Clinical Trials Transformation Initiative (CTTI)

10:05AM - What Makes a Good Cardiovascular Trial - DCRP Medical Officer Perspective
Shari L. Targum, MD
Team Leader, Division of Cardiovascular and Renal Products, CDER

10:10AM - What Makes a Good Cardiovascular Trial - DMEP Medical Officer Perspective
Ilan Irony, MD
Acting Lead Medical Officer for Diabetes Team II, Division of Metabolism and Endocrinology Products

10:15AM - What Makes a Good Cardiovascular Trial - DCRP Biometrics Perspective
H.M. James Hung
Director, Division of Biometrics I, OB/OTS/CDER, FDA

10:20AM - What Makes a Good Cardiovascular Trial - DMEP Biometrics Perspective
J. Todd Sahlroot
Team Leader and Deputy Director, Division of Biometrics 2

10:25AM - CDRH Requirements for Cardiovascular Trials
Hesha J. Duggirala, PhD
Epidemiologist, Center for Devices and Radiological Health (CRDH)

10:30 - Open Questions
Panel Discussion - all above speakers

11:00AM - BREAK

11:15AM - DCRI Data Collection: The Approach and Rationale
Ken William Mahaffey, MD
Associate Professor of Medicine: Faculty Director of Cardiovascular Mega-Trials; Director of Clinical Events Classification (CEC) Group, Duke Clinical Research Institute (DCRI)

11:20AM - ACC/AHA "Top 100" Cardiology Lexicon for Electronic Health Record (EHR) Systems
Daniel Roman
Special Health Information Technology, American College of Cardiology

11:25AM - Update on ARC Classification of Stent Thrombosis
Donal Cutlip, MD
Section Cheif, Interventional Cardiology, Beth Israel Deconess Medical Center; Associate Professor, Harvard Medical School, HCRI

11:30AM - What Device Safety and Clinical Endpoint Information We Should Capture in Case Reprot Forms: Special Sex Consideration
Roxana Mehran, MD
Associate Professor of Medicine, Director of Outcomes Research, Data Collection, and Analysis; Center for Interventional Vascular Therapies, Columbia University Medical Center; Joint Chief Scientific Officer, Cardiovascular Research Foundation

11:35AM - Standardizing Data Collection and Endpoints in Clinical Trials: Overcoming the Challenges
Alexander Lansky, MD
Associate Professor of Clinical Medicine, Columbia University Medical Center; Joint Chief Scientific Officer, Clinical Trial Center and Director, Women's Cardiovascular Health Initiative, Cardiovascular Research Foundation

11:40AM - The Challenges in Defining Endpoints
Steve Nissen, MD, MACC
Department of Cardiovascular Medicine, Cleveland Clinic

11:45AM - How the CEC Adjudicates - The Challenges and the Pitfalls (Cleveland Clinic Perspective)
A. Michael Lincoff, MD
Director, Center for Clinical Research and Vice Chairman for Clinical Research, Lerner Research Institute; Director, Cleveland Clinic Coordinating Center for Clinical Research (C5 Research); Vice Chairman, Department of Cardiovascular Medicine; Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; The Cleveland Clinic Foundation

11:50AM - Balancing Sensitivity of Detection with Clinically Meaningful Myocardial Infarction in Follow-up of Cardiovascular Trials
Laura Mauri, MD, MSc
Chief Scientific Officer, Harvard Clinical Research Institute; Associate Physician, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital; Assistant Professor, Harvard Medical School

11:55AM - Panel Discussion - Discussing the Gray Areas
Ken Mahaffey, Chris O'Connor, James Tcheng, Don Cutlip, Roxana Mehran, Alexandra Lansky, Steve Nissen, Mike Lincoff, Laura Mauri, Shari Targum, Karen Hicks, Steve Grant

12:25AM - LUNCH

1:05PM - DMEP Caridovascular Outcomes Trials
Mary Parks, MD
Director, Division of Metabolism and Endocrinology Products

1:10PM - Update on Testing the Proposed Standardized Definitions
Alan Goldhammer

1:15PM - Perspective on Standardized Definitions and Data Collection for Cardiovascular Trials
Yale Mitchel, MD
Vice President, Clinical Quantitative Science, Cardiovascular Disease Department, Merck Research Laboratoris

1:20PM - Standardized Data Collection for Cardiovascular Trials - Implications for Global Clinical Development
Barbara Tardiff, MD, MBA
Corporate Vice President, Data Sciences
PAREXEL International

1:25PM - 30 Years of CRF Standardization Efforts
B. Christine Clark, PhD
Executive Director, Biostatistics and Programming, ReSearch Pharmaceutical Servies, Inc.

1:30PM - European Perspective on Cardiovascular Outcome Trials
Gonzalo Calvo Rojas, MD
Agencia Espanola de Medicamentos y Productos Sanitarios

1:40PM - Panel (Open Questions)
Alan Goldhammer, Yale Mitchel, Douglas Peddicord, Barbara Tardiff, jean Morgan, Christine Clark, Bron Kisler, and others

2:00PM - Standardized Case Report Form for Cardiovascular Trials
Small Groups

3:45PM - Wrap-up/Future Plans/Adjournment
Karen Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products

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