October 11, 2018 – The Duke/Stanford CEC Summit brought together experts in clinical events classification from around the globe.
A unique, collaborative meeting aimed at establishing consistent standards globally for clinical events classification (CEC) and adjudication in clinical trials is being celebrated as a success and vital starting point for future work.
The first-ever Duke/Stanford CEC Summit was held Sept. 26-27 at the Chicago Hilton O’Hare, jointly hosted by the DCRI and the Stanford Center for Clinical Research (SCCR). Approximately 80 attendees took part in the two-day event.
“This meeting is all about bringing scientific rigor around CEC,” said Summit Co-Chair Renato Lopes, MD, PhD, faculty co-director of DCRI’s CEC team. “Our goal was to review how we do it now, but also predicting and trying to anticipate the future. Getting the right players in the room is critical – from academic, industry people, regulatory, and operational people – and try to share best practices, share experiences, and come to consensus. Or we recognize the things where there is no consensus, and there, try to innovate and inform the field.”
Numerous speakers and panelists from beyond Duke and Stanford supported that aim, with presenters representing the U.S. Food and Drug Administration (FDA), Harvard University, Cleveland Clinic, George Clinical, the Cardiovascular Research Foundation, ACI Clinical, Cardialysis, and more.
DCRI speakers included Professor of Biostatistics and Bioinformatics Frank Rockhold, PhD; CEC Co-Director Schuyler Jones, MD; CEC-Safety Surveillance Director of Operations Matt Wilson, RN; and Safety Surveillance Program Manager Ghazala Haque, MBBS, MHS.
Abraham Gutman, CEO of AGMednet – one of several CEC Summit sponsors – was impressed by the dialogue at the event, noting “people were able to ask the key questions that are in everybody’s mind, but never had a forum to ask.”
“I have heard a number of things (at the meeting) that are contradictory in a good way, in that people have different opinions,” he added. “My hope is that…we will find the commonalities in the processes that different people have been putting together and be able to use those more across projects in a way that…will achieve a better result.”
Event organizers look forward to sharing a white paper in the coming weeks that summarizes the learnings and opportunities identified at the meeting.
“This is just the beginning,” Lopes concluded. “We really hope that we’re going to create a core group of people that will meet every year and discuss and follow up on the action items …and move forward over the years. We can refine the discussion, we can create documents…that can model and help people do CEC all over the world.”
“I think this meeting is long overdue,” remarked Karen Hicks, medical officer with the U.S. FDA. “There was such active engagement – so many questions. There’s many CECs throughout the world and I think we’re all grappling with the same questions about how to do the job better.”