Digital Endpoint Adjudication

Purpose and goal

The goal of the project was not achieved when the goal was to digitize the evaluation of clinical events. On the other hand, the method proved to work very well for selection of clinical events and the focus was then on to carry out the tests in this area. The project changed the goal to try to digitize the identification of the events which deviates from the expected outcome. This was done with very successful results. From these tests, it was found that it is possible to create systems that digitalises´ deviating events and thereby streamline studies and increase quality.

Expected results and effects

The original results and the expected effects were not as anticipated as the original approach was changed. However, the result of moving the digitization step in the process of clinical trials turned out very successful and exceeded the expected effects. The effect of systematizing this work will provide more effective studies that save time and will enhance quality when proper events are captured to a greater extent. A side effect is that this work has a potential to also affect models for selection which could make a big impact.

Planned approach and implementation

The structure of the work changed to some extent with the new conditions of the project. The adjustment was not excessive and the implementation of the project could be made more or less as planned. The biggest challenge was to get access to all the experts in the various areas that the project was involved in. Hopefully, based on the successful outcome of the project, there can be an application in the future to develop a system that implements what has now been tested.