Heather Bristol, MS, is the Vice President of Informatics at Clinipace. Manejeh Yaqub, MD, is the CEC Consulting Expert.
Thank you to everyone who attended our webcast “Clinical Events Adjudication in the Digital Age.” In the presentation, we discussed when clinical events committees (CECs) are needed, CEC structures, CEC processes, what to look for when outsourcing CEC services and benefits of technology-enabled CEC processes.
During the webcast, we received a number of great questions from the audience. Therefore, we would like to share answers to those questions with you in a series of blog posts. Last week we discussed how to handle therapeutic areas where standard definitions are not available. In this blog post, we’ll answer a few questions regarding CEC structure, including the ideal committee size, if committee members can change during the course of a study and more. Check back next week for answers to more questions about the CEC process.
If you have any additional thoughts or questions for our experts, please share your comments below.
Q: What do you see as the ideal committee size, and how do you decide how many members to include?
A: It depends on the study. It is preferable to have a committee of odd numbers, and three-member committees are popular. In a large-volume studies with aggressive study milestone timelines or commitment challenges, five-, seven- or nine-member committees can be set up with a quorum decided upfront.
The ideal committee size also depends on the therapeutic area of the study. For example, a study with events randomized to CABG, PCI and medical therapy may need a CV surgeon, an interventional cardiologist and a cardiologist on the CEC. If one of the definitions for CEC events of interest includes an imaging endpoint, one may consider including a cardiac imaging specialist on the committee. Therefore, the ideal committee size is driven by the study: the endpoints or events of interest being adjudicated and the therapeutic area (in order to ensure that all relevant therapeutic area experts are consulted for ensuring scientific rigor of the definitions).
Q: Do you train medical monitors in adjudication?
A: All CEC members are trained in adjudication. This includes training on the study protocol, the CEC charter (including definitions), the TEMPO platform and the application of definitions of events. Each variable on the CEC adjudication form has specific and consistent guidance for adjudication for all members to eliminate bias. If a study has an independent medical monitor, the medical monitor would be familiar with the CEC processes and provide input to the charters and definitions as the sponsor medical expert. CECs may also allow medical monitors to participate in CEC meetings or issue queries to the CECs where clarity is needed on adjudication results.
Q: Is it possible for committee members to change during the course of a study? If so, how does that process work?
A: It is possible, though not preferable, for committee members to change. This would require sponsor approval and an update to the CEC charter at the time of member change as well as subsequent submission to competent authorities. In such a situation, it would be good to introduce the new member to other existing members and notify all impacted teams of the change. The new member will have to go through required training on study documents and any technologies used, such as Clinipace’s TEMPO system, like any other CEC member.