Clinical trials are complex. As in all complex businesses, it is important to consider the risk of unforeseen changes, errors and re-alignment and be prepared to repeat some of the processes to match the new realities. Re-adjudication is one of these instances.
Clinical endpoint adjudication is an added process to the already complex data collection performed during clinical trials. Special care must be given to the quality of data processing, blinding of identifying information, redundant reviews to avoid bias etc. However, no matter how carefully one might be in performing all these tasks, there are instances where re-adjudication of some clinical endpoints is necessary and the whole process must be repeated.
Deciding to re-adjudicate one or more endpoints in a clinical trial must be a carefully weighted decision because it will not only add cost and time but may create conflicts and confusion. Still, major corrections are sometimes necessary and re-adjudication may be the right thing to do if, for example:
• Key patient data have changed following data cleaning and query resolution
• Additional information has become available after the completion of the initial adjudication
• New information has become available that is susceptible to change the outcome
• Errors have been discovered in the adjudication packages
• Misleading information is identified that is due to poor translation of the initial information
This is a non-exhaustive list of course, as each trial has its own circumstances.
If the decision is made to repeat the adjudication process, all data must be verified by the investigative site and by the adjudication coordinator, the reviewers must be informed of the reasons for re-adjudication and the new or modified information available. A robust audit trail must also be recorded to document the new outcome that may differ from the initial one.
Overall, re-adjudication should remain a rare and exceptional case. The decision must be carefully evaluated but the study team should not hesitate to perform a re-adjudication if it is required by the circumstances.
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