Developing Need for Streamlining Adjudication in Clinical Trials

Regulatory Authorities are increasingly requiring sponsors to demonstrate acceptable safety profiles with respect to the occurrence of Major Adverse Cardiac Events (MACE), even for development programs whose primary indications are non-cardiac.  In tandem, trends in global clinical development have introduced new variables to be addressed when interpreting the occurrence of adverse events and the myriad of local/regional differences in event identification, diagnosis and reporting.

If a clinical trial requires adjudication of clinical events, typically a group of clinical experts is recruited to serve as the Adjudication Committee (AC).  The role of the Adjudication Committee is to create specific, standardised event definitions for each suspected event(s) of interest in a clinical trial.  By using these definitions for suspected events, clinical experts will review a standardised set of relevant source documents for each case included in the study.  These committees are also referred to as Clinical Event Committees (CECs), Clinical Endpoint Committees (CEC), Endpoint Adjudication Committees (EAC), Endpoint Validation Committees (EVC) and Clinical Adjudication Committees (CAC) among other names. 

Historically the process of managing Adjudication Committee members and their work has proven to be difficult, as there are many communications, logistical and time-related issues which need to be addressed in order to maximise the amount of adjudicated results available for review on an interim basis by study governance and safety committees.  In addition, certain randomised, controlled, non-inferiority trials are designed to anticipate the occurrence of a pre-specified number of adjudicated events in various treatment arms to rule out any presence of an increased risk over the standard treatment and therefore an efficient and rapid adjudication of potential events as they occur in the trial is important. Electronic adjudication enables many of these safety or efficacy decisions, such as retaining or closing a trial or closing or enriching a treatment or dosing arm, to be made in a faster and timelier way, thus identifying safety risks and/or efficacy signals earlier, thereby potentially reducing trial costs.