Identification of incorrect endpoint Adjudication during the study
Discovery:
Approx 18 mos after trial FPI ( 17 patients already treated), a CRA Oversight visit revealed that a site had been collecting data Overall Responses based on RECIST instead of the expected Lugano Response Criteria.
Solution:
Immediately escalated to Sponsor the findings and request immediate attention to this critical erroneous primary endpoint adjudication, overall responses by Lugano.
Learning lesson and conclusion:
Due to our real-time protocol assessment, we implemented an immediate ¡ corrective action during the trial: transitioning from RECIST to the correct Lugano Response Criteria. Without our intervention, this pivotal study might have failed due to incorrect adjudication of primary endpoint, resulting in: Significant loss of time, Waste of patient resources with potential reputational damage. Maieutics will conduct comprehensive monitoring of major study endpoints to proactively identify and mitigate potential risks or deviations—ensuring trial integrity and study conduct.