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Standardized Data Collection for Cardiovascular Trials - February 5, 2010


STANDARDIZED DATA COLLECTION FOR CARDIOVASCULAR TRIALS
February 5, 2010


FINAL AGENDA and PRESENTATIONS

(to view a presentation, click the title below)


8:00AM - Opening Remarks / Update since September 11, 2009 Meeting
Karen A. Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products (DCRP), CDER

8:10AM - Cases used for Adjudication
8:10AM - Adjudication Results
Karen A. Hicks, MD / H.M. James Hung, Director, Division of Biometrics I
OB/OTS/CDER, FDA

8:30AM - Final Discussion of Team 1 Definitions

  • Myocardial Infarction
  • Cardiovascular Death
  • Non Cardiovascular Death
  • Undetermined Cause of Death
  • Bleeding

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)

9:30AM - Final Discussion of Team 2 Definitions

  • Stroke
  • Coronary Revascularization Procedure
  • Peripheral Revascularization Procedure
  • Stent Thrombosis

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

10:30AM - Final Discussion of Team 3 Definitions

  • Hospitalization for Unstable Angina
  • Hospitalization for Congestive Heart Failure

Steve Nissen, MD, MACC
Department of Cardiovascular Medicine, Cleveland Clinic

11:30AM - Data Standards: Future Plans
Bron Kisler, CDISC
Brian McCourt, DCRI

11:45AM - Women CRF
Roxana Mehran, MD / Karen A. Hicks, MD
Salma Lemtouni, MD, MPH
Medical Officer, Office of Women's Health

12:00 noon - Wrap-up / Future Plans / Adjournment
Karen A. Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products (DCRP), CDER


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