SCCR Hosts Unique Event with Duke Clinical Research Institute

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 Duke Clinical Research Institute (DCRI) and the Stanford Center for Clinical Research (SCCR). Approximately 80 attendees took part in the two-day event.

“What we wanted to do here was bring together the key stakeholders from academia, from industry, from the regulatory community to really come to some consensus about quality operations and the conduct of CEC around the world,” said Kenneth Mahaffey, MD, director of SCCR and co-chair of the CEC Summit. “There’s an incredible opportunity to better define the processes that we implement in conducting event adjudication. We need to do a better job of quantifying the metrics and setting standards of quality in CEC or event adjudication, and then we need to create a path moving forward.”

Numerous speakers and panelists from beyond Duke and Stanford supported that aim, with presenters representing the U.S. Food and Drug Administration, Harvard University, Cleveland Clinic, George Clinical, the Cardiovascular Research Foundation, ACI Clinical, Cardialysis, and more.

Stanford speakers included SCCR Associate Director Amol Rajmane, MD, and Mark Hlatky, MD, professor of Health Research and Policy in the School of Medicine.

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 will draft a white paper in the coming weeks that summarizes the learnings and opportunities identified at the meeting.

“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 are many CECs throughout the world and I think we’re all grappling with the same questions about how to do the jobs better.”

“We learned and we taught each other about our own practices, about our own challenges, and about opportunities to advance the field of clinical event adjudication,” Mahaffey said. “I challenged attendees to think about how we can better quantify the impact that an adjudication has on clinical research.”