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. In previous blog posts, we’ve answered questions about therapeutic areas for which standard definitions are unavailable, the CEC structure and the CEC process. In our final blog post, we’ll discuss a major difference between electronic adjudication and traditional adjudication.
If you have any additional thoughts or questions for our experts, please share your comments below.
Q: Does the FDA or any regulatory agency view electronically blinded adjudicated results more favorably than traditionally adjudicated results?
A: There are no clear regulations around this, but from a quality standpoint, in our opinion it is definitely more favorable. In addition, electronically, one can present blinded adjudications as truly independent assessments. Finally, electronically blinded adjudication provides good audit trails, which, in our opinion, are viewed more favorably by regulatory authorities.