The use of Clinical Endpoint Committees for centralized adjudication of efficacy and/or safety endpoints can help to standardize outcomes and optimize the quality of clinical trial data, driving study success.
Some compounds and many devices face the challenge of defining efficacy or safety endpoints so that they are scientifically measurable, objective, and valid. Often, clinical trials are driven by clinical events, which 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/adjudication committees, otherwise known as Clinical Endpoint Committees, can play a significant role in reviewing and classifying suspected efficacy and/or safety endpoints to provide standardized endpoint outcomes for statistical analysis. Enabling this centralized adjudication process enhances the quality, validity, and integrity of study results, which can improve the likelihood of clinical trial success.
In this white paper, we discuss the value of Clinical Endpoint Committees in drug development or medical device evaluation programs and explore the process of organizing, managing, and implementing a centralized adjudication process for standardizing study endpoints.
A Clinical Endpoint Committee (CEC) is an independent group of clinical and/or diagnostic experts charged with: