Endpoint adjudication by independent Clinical Events Committees has increased over the last ten years. Endpoint adjudication workflows are dynamic and interactive, with multiple steps, data sources, contributors and stakeholders. Below are three commonly used options for workflow that can be implemented for event adjudication.
Parallel Review with Phase II Review Committee
This is one of the most common workflows for endpoint adjudication. Two Phase I reviewers work independently to complete their assessments. If the assessments match at the defined points, an outcome form is completed within the system. If the assessments do not match, the event goes to a review committee who determines a final assessment.
Paired Consensus with Phase II Committee
This is also a common workflow for endpoint adjudication. In this case, the Phase I reviewers can see each other’s work and they may discuss the event to reach a consensus.
An adjudication committee, either co-located (a standing roster of members who often work together in the same organization) or compiled (members selected individually for a particular trial), meet to review each event. Committee members are required to be physically present at meetings.