Clinical Events Committees (CECs), also known as Clinical Endpoint Committees, focus on the adjudication of major endpoints in clinical trials. CEC adjudication provides a standard, systematic and unbiased assessment of endpoints to determine whether they meet protocol-specified criteria.
Information reviewed by the CEC for each endpoint is primarily based on source documentation collected from the patient chart. This may include laboratory, pathology and/or imaging data, admission history, procedure reports, progress notes, discharge summary, autopsy reports, and any other data deemed relevant to the review. Such committees are particularly valuable when endpoints are subjective and/or require the application of a complex definition. For trials with relatively long-term clinical endpoints that span geographic regions and include diverse clinical presentations and practice patterns, this independent review delivers uniform data by eliminating discrepancies that may result from observer-dependent assessments across varying geographic areas.
Novella offers our customers the necessary expertise for successful implementation of endpoint adjudication activities for medical device trials. Novella’s Oversight Group Management can manage the process from beginning to end, or work with customers on a customized list of services. An experienced CEC Lead Specialist oversees each clinical study and the CEC process is tailored to study-specific needs. Our capabilities include:
- Identify CEC members, with access to a global pool of board certified physicians through our Physician Network
- Manage member contracts and payments
- Prepare Physician Payment Sunshine Act reports for sponsors
Charter and Process Development
- Develop the CEC charter and site manual, in collaboration with Sponsors
- Design and set-up the optimal CEC workflow for each trial based on the charter
- Collaborate with sponsors and CEC members to identify appropriate data required for adjudication
- Electronic endpoint adjudication in a single system that allows global users, including CEC members, sites and endpoint coordinators 24/7 access to data and event adjudication processes
- Collection and maintenance of data related to clinical events
- Compilation and distribution of blinded study documents to committee members for review. Study documents can be reviewed remotely within the centralized web-based adjudication system, with no need for shipping paper files.
- Reviewers’ assessments are processed within the system and automatically escalated to secondary or full committee review as appropriate
- CEC adjudicated results are provided as part of interim and final statistical analyses