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 with you answers to those questions in a series of blog posts. In today’s post, we’ll discuss how to handle therapeutic areas where standard definitions are unavailable. Check back Thursday for more questions regarding CEC structure.
If you have any additional thoughts or questions for our experts, please share your comments below.
Q: Standard definitions are available in some therapeutic areas like cardiovascular and cerebrovascular, but how do you handle areas where standard definitions are not available?
A: It depends on the protocol. You’re right that standard definitions are more widely available in the cardiovascular and neurovascular therapeutic areas. However, there are protocols with specific endpoints that may require higher utilization of consistent definitions, which the CEC can also help refine for future scientific endeavors. Therefore, it really depends upon what endpoints or safety events each study is looking for.
A good example would be stem cell studies that involve harvesting of stem cells through sternal puncture, which are prone to bleeding complications that are often severe and serious. For such studies, a consistent bleeding definition distinguishing various categories of bleeding would be of potential benefit. CEC members typically assist the steering committee, advisory board or the sponsor who developed the protocol in developing or refining these definitions. So for any study protocol, when you decide to have a safety-related endpoint or a very specific endpoint, you can always come up with a consistent definition around it that can be applied for that particular protocol, and then work with the regulatory agencies on ensuring that it is the right definition. Therefore, not only do CECs assist with adjudication, they also assist with developing these definitions for events of interest.