In our previous CECs blogpost, we reviewed why Clinical Endpoint Committees (CECs) are so crucial for successful trials today. But just how do sponsors establish and operate a CEC? It’s a complex process that can be broken down into these eight key steps:
1. Understand the deep level of commitment required in putting a CEC together.
CECs present a major logistical challenge for sponsors. But coordinating CEC members and disseminating large amounts of data quickly helps facilitate efficient and rapid adjudication of events as they occur during a trial. That’s why successful CEC implementation requires some serious cross-functional planning as early on in development as possible.
It’s also important keep in mind that centralized endpoint adjudication involves many players. Such endpoint process flows are inherently complex and dynamic, involving multiple stakeholders, including:
- Data coordinators
- CEC members themselves
- Members of the clinical study team, including site staff, monitors, data managers, biostatisticians, and pharmacovigilance groups.
Sponsors must be prepared to ensure that all these moving parts can work together effectively.
2. Develop an endpoint data-capture strategy.
Here, clear definitions of endpoint criteria, including their identification and reporting processes, will need to be established.
3. Establish an endpoint case-management plan.
During this step, sponsors must clearly outline endpoint process workflows and any forms to be used. It’s often a good idea for sponsors to centralize case-management functions to a specialized group, such as a Data Coordinating Center or a contract research organization.
4. Structure a CEC adjudication model.
There are multiple models for CEC adjudication, but the two most common are the parallel review model and the consensus model. Each of these has its own pros and cons regarding cycle, time, cost and potential impact on quality and consistency of outcomes.
5. Select CEC members.
Selection process should be guided by a set of documented procedures for identifying, qualifying and contracting with CEC members. All CEC members should have extensive therapeutic-area experience and specific expertise regarding the endpoints they will assess. They’ll also need the ability to accurately review records, make independent decisions and understand the independent roles of the CEC within the overall regulatory approval process.
The CEC will also need a chairman, who should have previous experience as a CEC member. The chairman should also possess the leadership skills necessary to facilitate communication, arbitrate disputes and make decisions.
6. Develop a CEC charter.
The CEC charter is a document that describes the Standard Operating Procedures for the adjudication process of a specific clinical trial, as well as the expectations and goals of the CEC itself. While FDA approval of CEC charters is not currently required, regulatory agencies should be informed of its contents. The CEC charter is typically approved by the Steering Committee and the Data Safety Monitoring Board before the beginning of a trial.
7. Ensure effective communication.
Clear and timely communication between sponsors, CEC members, Clinical Safety, Data Management and study investigators is crucial for the CEC to review and arrive at endpoints for study decisions. Consequently, effective communication between these groups is vital for a successful multicenter trial.
8. Integrate centralized adjudication into the overall clinical trial.
Sponsors must consider how the data exchange required for the endpoint process impacts every aspect of study planning. Proactive measures need to be taken early in development to accommodate the increased level of communication and coordination this valuable but complex tool will bring. A CEC process that is built into a trial plan will be more effective and efficient than one that’s been retrofitted later on.