Developers of medical devices face the challenge of defining efficacy and safety endpoints that are scientifically measurable, objective, and valid. Clinical trials are often driven by clinical events that may lack standard definitions or are subject to interpretation. In these scenarios, sponsors need a reliable method for reducing the impact of variability on conclusions drawn from analyses of outcomes data.
Independent endpoint assessment and adjudication committees, otherwise known as clinical endpoint committees (CEC), can play a significant role in reviewing and classifying suspected efficacy and/or safety endpoints to provide standardized endpoint outcomes for statistical analysis. This centralized adjudication process enhances the quality, validity, and integrity of study results, which can improve the likelihood of clinical trial success.
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:
- 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?
Title: The Role of Clinical Endpoint Committees in Medical Device Trials