Agenda and Slides November 2013

CEC Adjudication Thinktank Meeting 

A Cardiac Safety Research Consortium in Collaboration with FDA

10903 New Hampshire Avenue, Silver Spring, Maryland 20993 

White Oak Facility, FDA Headquarters • Silver Spring, MD • November 6, 2013


Introduction: Philip Sager (Sager Consulting)

Setting the Stage: Jonathan Seltzer (Applied Clinical Intelligence)

Session I: Why Do We Need Adjudication: Co-Chairs: Jonathan Seltzer and Philip Sager
Point: CV Adjudication is Necessary for Trials Conducted by Cardiologist: Venu Menon (CCF)
Counterpoint: CV Adjudication is NOT necessary for trials conducted by Cardiologist: Janice Pogue (McMaster University)
Industry Perspective: Peter DiBattiste (Johnson and Johnson)
EMA Regulatory Perspective: The role of study design and PI expertise on the need for adjudication: Giuseppe Rosano (EU Regulatory)
FDA Regulatory Perspective: The role of study design and PI expertise on the need for adjudication: Norman Stockbridge (FDA)

Session II: Event Identification and Ascertainment Strategies: Co-Chairs: Stephen Grant and Ken Mahaffey
Perspectives on how wide a net should be cast and on implications when adjudication is post-hoc: William White (University of Connecticut)
Record Experience: Kenneth Mahaffey (Stanford University)
Sampling Model for Adjudication: Alan Smith (Applied Clinical Intelligence)
Potential Uses of Registry Studies to Improve Adjudication: Ralph Brindis (ACC)
Clinical definitions for CV endpoints and translation into computable concepts: James Tcheng (Duke University)

Session III: Clinical Development and CV Endpoints- Potential Impact on Adjudication Strategies: Co-Chairs: Mary Jane Geiger and William White
Challenges in adjudication: What makes a case non-accessable: Daniel Lenihan (Vanderbilt)
Uses of CV Endpoint Document in a CV Trial and non-CV Trials
Industry Perspective:
 Mary Beth Sabol (GSK)
Regulatory Perspective: Karen Hicks (FDA)
During clinical development in a non-CV trial, a CV safety signal is detected- Should these events be adjudicated and using which methodologies: Small and Large Databases: John Finkle (GSK) and Amy Levine (Shire)
Factors to Consider in the Composition of an Adjudication Committee: Peter Kowey (Lankenau)

Session IV: Adjudication: Practical Aspects and Future Directions: Co-Chairs: Ralph Brindis and Jae Kim
How to determine strength of evidence to ensure confidence in CEC decision making? Soneil Guptha (Icon)
Cost Efficient and Risk Based Adjudication : Andrew Lawton (Boehringer Ingelheim)
Post Marketing Signals and Large Database Evaluation- Can we reliably assess safety in the early post-marketing period? Mark Hlatky (Stanford)
Regulatory Directions: Patrick Archdeacon (FDA)

Summary Slide: Mary Jane Geiger (Regeneron)