Abstract
Clinical endpoint adjudication (CEA) is a standardized process for assessment of safety and efficacy of pharmacologic or device therapies in clinical trials. CEA plays a key role in many large clinical trials with the aim of achieving consistency and accuracy of the study results, by applying independent and blinded evaluation of suspected clinical events reported by investigators. However, due to high costs there are different opinions regarding the use of central adjudication versus more simplified strategies or site-based assessments and whether the final results differ significantly. There is a lack of scientific evaluation of different adjudication strategies, and more knowledge is needed on the optimal adjudication process and how to achieve the best cost-effectiveness. New methodologies using national registry data and artificial intelligence may challenge the traditional adjudication strategy and could potentially reduce cost considerably with a similar result. Further research and evidence in this field of clinical trials methodology are essential.
Highlights
Clinical endpoint adjudication (CEA) is a standardized process for the assessment of safety and efficacy of pharmacologic or device therapies in clinical trials
Central adjudication plays a key role in many large clinical trials with the aim of achieving consistent, accurate, independent, unbiased, and blinded evaluation of suspected clinical events reported by investigators
At Uppsala Clinical Research Center (UCR), we have offered CEA services for clinical trials for 10 years and have substantial experience of adjudication of outcomes, from small academic studies to registry-based randomized clinical trials and large big pharma phase III trials for registration purposes
Summary
Clinical endpoint adjudication (CEA) is a standardized process for the assessment of safety and efficacy of pharmacologic or device therapies in clinical trials. Despite a long history of centralized adjudication of both cardiovascular (CV) and non-CV endpoint events, there is a need for the clinical trials community to establish a set of best practices to inform how CEA committees should be structured and operated. Recently an international expert group, the Bleeding Academic Research Consortium (BARC), developed the BARC standardized bleeding criteria which are widely accepted (3). Another important endpoint in CV outcome trials is the definition of myocardial infarction (MI), which has been updated several times by the Universal Definitions expert group (4), and a new updated definition is awaited shortly. This review aims to provide an overview and highlight the advantages and the challenges of performing centralized CEA and to provide some future perspectives for the role of central adjudication in future clinical trials
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