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...
For a Clinical Endpoint Committee (CEC) to make important decisions, it needs the data to do so. That’s why developing an effective and reliable endpoint data capture strategy is a vital part of working with a CEC. Before starting a clinical trial, sponsors should be able to answer these questions. 1. What needs to be defined?...
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....
Also called Endpoint Adjudication Committees, Clinical Endpoint Committees (CECs) are an increasingly common component of drug development and medical device evaluation. A CEC is a centralized decision-making body for safety and efficacy endpoints. The goal of a CEC is to standardize outcomes and optimize data quality, ultimately driving study success. A CEC addresses the challenge...