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Five Early Warning Signs Your Clinical Trial Is Moving Off Plan
Clinical trials rarely miss a result overnight. They miss it in small, explainable slips that nobody owns. These five signs are early enough to matter.
1. The forecast keeps moving, the reason does not
Enrolment dates slide by two weeks, then four, with the same explanation. A forecast that only updates in one direction is a finding.
2. Issues have names and no dates
The register lists the problem and not the person who will close it. Project management exists to put both on the page.
3. Monitoring reports arrive too late to use
A report that lands after the next decision meeting is an archive. On-time submission is part of monitoring quality, not an administrative courtesy.
4. One site has gone quiet
Quiet is not stable. It is often a coordinator gap, a pharmacy delay, or an investigator who has stopped engaging. See how to identify an underperforming site.
5. The dashboard is greener than the calls
If the conversation in the study team is anxious and the metrics are calm, you are measuring the wrong things. That gap is an oversight problem.