My Worst Nightmare In Randomization And Trial Supply Management: Accidental Unblinding

By Sheri Lillis, RTSM Solution Services Principal at Medidata

As a Medidata Rave RTSM expert, one unsettling scenario keeps this author awake: accidental unblinding. This nightmare can take a variety of different forms, including, but not limited to:

• Mistakenly revealing patient details, including drug assignments, during a troubleshooting session with a study monitor via screen sharing;
• Accidentally exposing part of a study's inventory by sharing a screenshot of a specific numbered inventory meant for one kit type; and
• Sending a complete patient list report with unblinded treatment assignments to the blinded study team, risking unblinding the entire study.

Accidental unblinding is a legitimate concern that highlights the risks within Randomization and Trial Supply Management (RTSM) in clinical trials.

In order to minimize bias in clinical trials, blinding is crucial. In double-blind studies, the blind is maintained until study procedures are complete and data is ready for unblinding. Unblinding happens when someone accesses information revealing a patient's treatment assignment. Unintentional unblinding can lead to serious consequences, such as removing team members, excluding patient data, or invalidating the study outcome, pushing study teams to work diligently to prevent it.

Learn how collaborative efforts from study managers, supply managers, biostatisticians, designers, and clinicians can better protect the blind in clinical trials and prevent accidental unblinding.