This webinar discusses the value of clinical endpoint committees in medical device evaluation programs and explore the process of organizing, managing, and implementing a centralized adjudication process for standardizing study endpoints.
CEC-adjudicated endpoints may be used in critical decision-making processes including power estimations, periodic safety reviews by data monitoring committees or data safety and monitoring boards, sample size re-estimation and other interim analyses, and overall efficacy and safety analyses. Consequently, CEC-adjudicated outcomes need to be finalized and made available on an ongoing basis throughout the lifespan of a trial. By enabling more timely identification of efficacy signals or safety risks, central adjudication may facilitate go/no-go decisions and potentially reduce trial costs. Clinical endpoint committees, therefore, play an integral role in adaptive trial designs.
Sponsors who are considering use of a clinical endpoint committee should keep the following in mind to support successful central adjudication:
- The study protocol should include a well-defined data capture strategy that addresses handling of suspected endpoint and adjudicated outcome data, which should be defined in a clinical endpoint committee charter
- The study protocol should include a clearly delineated tactical plan for effective endpoint case management
- The clinical endpoint committees adjudication workflow must be structured to deliver consistent, reliable, and accurate results
Among the questions the speakers address, are:
- What methods should be considered to support accurate detection and reporting of all potential suspected endpoints?
- How will the suspected endpoint and adjudicated outcome data be handled within the overall study data-capture plan?
- What methods will be used to ensure that final adjudicated outcomes are complete and current?