Endpoint Adjudication: Handling Changes in Patient Data

By Dimitri Stamatiadis 11 Dec, 2018

Handling changes in patient data during the Adjudication study: it is not carved in stone

Changes, corrections or additions to patient data may occur during a clinical trial and may impact endpoints assessment. Ensuring close monitoring and facilitating prompt action is the role of a well-thought endpoint adjudication software platform.

So, you look at your clinical trial dashboard and all you see is green. All indicators show that you are on time. Enrolment is going well, data collection is steady, queries are low, endpoint adjudication has been performed for all required data points. All is good. Or is it? 

Has anyone checked if patients’ records have changed in any way since adjudication was performed?
Only serious adverse events are closely monitored (by drug safety) for changes and complementary information. And if there are changes, do they impact the adjudication result in any way?

Patient information is not carved in stone.
It may be updated, complemented, changed, rectified. Some of these changes may warrant a reassessment of one of the endpoints. Discovering this at the end of the study (or worse, not at all) may have an impact on the outcome, validity and quality of the results. It is therefore paramount to monitor changes to the patient data and be able to trigger a re-assessment of the endpoints by the independent committee. 

This is exactly what eAdjudication Software platform is able to do by establishing a direct link to the clinical database and by executing dedicated algorithms that look for changes in the data.
Specific rules programmed in the software can trigger a re-assessment workflow and send the case to the appropriate reviewers

Have you considered the impact of trial process changes?
In our next post we will discuss changes in processes during the conduct of a clinical trial, potential impact on the endpoint adjudication process and ways to remediate.

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