Clinical Events Committee (CEC)

Clinical Trials

What is a CEC?

In clinical trials that include a high-risk patient demographic, a clinical events committee (CEC) may be appointed at the sponsor’s discretion. Depending on the study, an institutional review board (IRB) may also request a CEC before study approval. A CEC adjudicates adverse events per the charter during the course of a clinical trial and can review the significance of the event in relation to the investigational product. A CEC is also tasked with protecting the integrity and minimizing bias in the data that are reviewed by a data safety monitoring board (DSMB) by performing endpoint assessments. A DSMB oversees the trial data as well as the safety of studies that include a high-risk patient demographic. These independent parties will work together to ensure that the data from high-risk clinical trials are monitored properly. This blog will discuss selecting members, examining conflicts of interest, and conducting CEC meetings.

Selecting Members

The composition of a CEC depends on the study being conducted. A CEC should primarily consist of medical professionals with expertise in the disease state or imaging modality to be assessed. To remain independent, these individuals should not be affiliated with the ongoing clinical trial. Qualified individuals are nominated to participate in the committee. An individual’s reputation, skills, association with any conflict of interest, and experience will be evaluated by the CEC administrator to determine his or her position. He or she may be subjected to résumé/CV assessment, interviews, and phone screening.

Conflicts of interest

An individual’s affiliation will be assessed to rule out any conflicts of interest that may arise if he or she were placed on the committee. Members that participate in CECs may have a conflict of interest with the clinical trial being conducted if for example the member was involved in the study design, securing study funding, or responsible for study conduct (sponsor or CRO). These conflicts will be examined prior to the selection of a CEC member and during each CEC meeting conducted. If a conflict of interest is identified, the CEC administrator will be contacted to evaluate the information provided. If a conflict of interest is identified he or she will not be allowed to participate, discuss or vote in CEC meetings related to the clinical study.

Conducting CEC meetings

Once a CEC is established, meetings will occur, the frequency and purpose of which will be determined as needed. A meeting will entail an assessment of any adverse events based on the data provided to determine whether the event was product-related or not. The members may also meet to discuss the validity and integrity of the data and the reporter. There will be an open and closed session to each meeting in which the open session will include other individuals in addition to CEC members and the closed session will only include CEC members.

CEC meetings provide a sounding board for experts in the field of the investigational product to determine if an adverse event is related to the clinical intervention. These gatherings allow the potential to spot unanticipated adverse events linked to treatments, ultimately providing another level of safety to patients. Altogether, a CEC is another valuable tool available to ensure the safety and welfare of patients participating in clinical research.

MED offers a variety of clinical trial services, and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

Contact us to discuss how you can utilize a CEC in your clinical study 855.463.1633 | medinstitute.com.