What is a Clinical Events Committee?
Clinical endpoints are chosen during trial design as events to measure to demonstrate the safety or efficacy of a therapy. To reduce variability, a charter of event definitions is drawn up. A CEC is an independent expert group tasked with reviewing and adjudicating suspected study endpoints to determine whether they meet the pre-specified definitions in the charter.
Why is a Clinical Events Committee so important?
The use of an independent blinded panel with appropriate expertise is essential to ensure the integrity of the data and that consistent and reliable adjudication-outcomes are obtained.
Once the CEC charter development is complete, there are a number of steps that must be completed to implement the process. Investigative sites and clinical study teams must be trained accordingly. It is essential that each party understands their unique role in the process. The CEC charter will define the source documents, medical records and other data elements that must be collected and submitted to the committee for adjudication. Investigative sites will send these elements to a coordinating center. It is essential that all data elements are collated in a timely manner to ensure prompt and judicious review. The site monitor will assist with the collection of the required data elements. Data packets must be appropriately redacted and all documents must be translated to English language for committee review as well as for filing in the trial master file. The complete data packets are submitted to the committee for review and assessment and this is typically done by means of an electronic adjudication system. The committee members document their assessment directly in the system via completion of an adjudication CRF. The final adjudication outcomes are provided to biostatistics for data analysis.