Endpoint Adjudication (EA) is the process by which clinical trial endpoints are not assessed by the investigator physicians only but in an entirely blinded way by an independent adjudication committee of experts. In case of disagreement, either between the investigator and the committee or among assessors, consensus is obtained through ad hoc meetings.
Clinical Event Adjudication has been shown to reduce bias and variability, thus increasing the power of detection of a difference between two treatments or between active and placebo. EA is increasingly being requested by regulators and welcomed by MAA dossier reviewers as an additional guarantee of quality and accuracy of the study results.
But Event Adjudication (EA) also adds complexity to the planning and execution of a clinical trial. A cloud-based, real-time EA platform can allow all stakeholders to manage the full process efficiently and with high quality at a limited cost by providing the adjudication committee members with accurate, clean and complete data as soon as these become available, regardless of their location. Such platforms can highly reduce timelines of clinical assessments by directly integrating different data sources into “event packages”, assign different events to reviewers, handle Committee Members' disagreements and support a fully transparent and documented operating procedure.
Ethical’s eAdjudication® endpoint adjudication software connects in real time investigators, sponsors and adjudicators.
Based on the committee charter rules, the real-time adjudication platform handles role-based access, workload distribution, quality assurance and disagreement resolution. Through a user-friendly interface, study sites can easily verify data integrity and may partially automate information capture; committee members can visualize information (e.g. DICOM images) and provide assessments. In addition, study managers can fully view the state of operations while performance management tools help early detection of outliers and prompt correction of process flaws.
Finally, the real-time electronic adjudication management system provides easy and accurate archiving of the produced material and GCP compliance and offers robust data protection and control: all transient information is encrypted and all actions and data are captured in a full audit trail sealed with cutting edge technology (block chain).
The return on investment is obvious: using a well-designed electronic EA software such as Ethical’s eAdjudication® for exchanging the necessary information in real time and achieving timely completion of the EA process can greatly reduce the additional burden of EA on the overall cost of a clinical trial.
[1] Effects of Central Adjudication in Bias, Variability, Sample Size and Study Power. Juan Torres and Mimmo Garibbo, CBI Endpoint Adjudication 2016 Event. May 4-5, 2016 | Philadelphia, PA
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