CEC Summit

Duke/Stanford CEC Summit

September 26-27, 2018  |  Chicago Hilton O'Hare

Scientific, Regulatory, and Operational Best Practices for academic and industry thought leaders involved in adjudication.

An exciting new clinical events classification and safety meeting took place September 26-27 in Chicago, coordinated by the Duke Clinical Research Institute and the Stanford Center for Clinical Research.

Designed for academic and industry thought leaders involved in adjudication, the two-day symposium delivered provocative and challenging discussions on trends in the industry and the development of CEC/safety best practices, strategies, and quality standards. 

We brought together thought leaders from academia, the FDA, and industry to moderate informative sessions, including topics such as CEC audit readiness, emerging trends in safety and efficacy, new technologies, and data quality and standards.

CEC Summit Co-Chairs

Renato D. Lopes, MD, MHS, PhD
Co-Chair, Duke/Stanford CEC Summit
Professor of Medicine, Division of Cardiology
Duke University Medical Center
Director, CEC-SS, Duke Clinical Research Institute (DCRI)

Kenneth Mahaffey, MD
Co-Chair, Duke/Stanford CEC Summit
Professor, Stanford University School of Medicine
Vice Chair of Clinical Research, Department of Medicine
Director, Stanford Center for Clinical Research (SCCR)

Program Agenda

Day 1

7:45 a.m.-8:45 a.m.
Registration and Breakfast

8:45 a.m.–9:00 a.m.
Opening Remarks & Welcome: Renato Lopes (DCRI) and Ken Mahaffey (SCCR)

9:00 a.m.–12:00 p.m.
Sessions on Quality: Moderators Karen Hicks (FDA) and Ken Mahaffey (SCCR)
Discuss current quality metrics in event adjudication
How to prepare for a regulatory or industry audit
Mechanisms to integrate safety reporting and event adjudication

  • Session #1: CEC Quality and Audit Readiness: Karen Hicks (FDA) and Maria Ali (George Clinical)
  •  Session #2: Emerging Trends in Safety & Efficacy: Venu Menon (CCF) and Ghazala Haque (DCRI)
  • Session #3: TBA Panel Discussion

12:00 p.m.–1:00 p.m.
Break for Lunch and Networking

1:00 p.m.–4:00 p.m.
Sessions on Efficiency: Moderators Bernard Chaitman (St. Louis) and Renato Lopes (DCRI)
Review historical operations of CEC
Discuss leveraging technology to improve efficiency of CEC processes
Understand how big data and AI can improve CEC – Where are we now?

  • Session #4: CEC Efficiency and Technology: C. Michael Gibson (Harvard) and Amol Rajmane (SCCR)
  • Session #5: A New Era in Data: Ori Ben-Yehuda (CRF) and Frank Rockhold (DCRI)
  • Session #6: TBA Panel Discussion

4:00 p.m.–4:30 p.m.
Closing Remarks, Moderator/Speakers and Audience Engagement

5:00 p.m.–6:00 p.m.
Cocktail Reception for Networking

Day 2

7:45 a.m.-8:45 a.m.

8:45 a.m.–9:00 a.m.
Opening Remarks & Welcome: Renato Lopes (DCRI) and Ken Mahaffey (SCCR)

9:00 a.m.–11:00 a.m.
Sessions on Collaboration: Moderators: Kenneth Mahaffey (SCCR) and Jonathan Seltzer (ACI Clinical)
Discuss the regulatory, industry and academic perspectives on CEC
Review implementation of current standardized definitions – Successes and Pitfalls
Discuss the importance of event adjudication collaboration and distributive operations model

  • Session #7: Collaboration and Consensus – Standards Around Data, Definitions and Operational Workflow: Ernest Spitzer (Cardialysis) and Matthew Wilson (DCRI)
  • Session #8: Strategies and Best Practices: Roxana Mehran (CRF) and Mark Hlatky (Stanford)

11 a.m.–12:00 p.m.
Final Session and Panel Discussion

12:00 p.m.–1:00 p.m.
Lunch and Networking

Thank you to our Summit Sponsors