Why You Need Real-time, Prospective Adjudication
The decision to use centralized adjudication must be made at the trial planning phase. A CEC expert should be engaged during trial design. Critical decisions regarding types of endpoints used in the primary and secondary outcomes should ideally be made in advance and after discussion with an expert, as errors in endpoint selection are difficult to rectify later.
In addition to the definition of events, one of the most crucial aspects of endpoint adjudication is defining the workflow, from gathering the required site documents, to translation and presentation of the event data to the CEC for adjudication. These workflows should be designed in parallel with the CEC charter and aligned with the overall trial design and collection of trial documentation. The adjudication operation can involve multiple stakeholders (e.g. CRO, CEC, study sites) and it is important that the various steps and procedures involved in the process are defined early on to ensure workflows are correct.
In addition, real-time, prospective adjudication is now considered the gold standard and allows live metrics to be utilized in assessing trial progress. Gone are the days of waiting until the trial finishes and adjudicating all the events at the end. When adjudication is performed in real time, it is easier for sites to act on CEC requests for more information. In addition, other trial committees, such as the executive committee or the data safety monitoring board, rely on timely adjudication to perform their functions and run the trial efficiently. There is no one-size-fits-all approach to the CEC and the CEC workflow as it must be tailored to the trial design.
When done correctly, tried and true workflows and event definitions ensure consistency and reproducibility and thus the reliability of final results in clinical trials.
Process matters in endpoint adjudication. From consistent data collection and de-identification, to performance metrics and oversight, long-term adjudication functions benefit greatly from systems that can QC and follow the data from event trigger to final outcome. Such automated databases can produce quality reporting and visible metrics that provide the key constituencies including sponsors and CROs with the data necessary to do course corrections and keep clinical trials on track in real time.
Pardeep Jhund, Global Clinical Trial Partners Ltd
Dr Pardeep Jhund is a cardiologist and co-founder of Global Clinical Trial Partners. He has a specialist interest in heart failure and clinical trials. He has been a member or chair of a number of adjudication committees for academic and industry-sponsored trials over the past 20 years.
Michael MacDonald, Global Clinical Trial Partners Ltd
Dr Michael MacDonald is a cardiologist and co-founder of Global Clinical Trial Partners. He has 15 years’ experience in the management of the endpoint adjudication process from charter development to adjudication. In addition, he has chaired and been a member of numerous committees for trials with both academic and industry sponsors across multiple disease areas.
Abraham Gutman, president and CEO, AG Mednet
Abraham Gutman founded AG Mednet in 2005 and leads the company’s mission to improve, automate and expedite outcomes in clinical trials by ensuring quality and compliance within drug, biologic and device trials. Abraham holds a BA in Computer Science from Cornell University and an MSc in Computer Science from Yale University.