Case Study:
Performing an Emergency Unblinding as part of a clinical trial

Emergency Unblinding: an important protocol within clinical trials

The reason for unblinding

In an emergency medical situation, the treating physician usually wants to know what study medication the patient is taking, and many of the calls that ESMS receive start with a request for unblinding.

While it is often possible to prevent unnecessary unblinding, in some cases it is essential for unblinding to be performed quickly, to ensure safe management of the patient.

However, it is crucial to ensure that the unblinding request is from an authorised user (usually the treating physician), and that the emergency management of the patient is indeed dependent upon knowing the treatment allocation.

How ESMS handled the situation

Outcomes and benefits

  • Rapid emergency unblinding performed within 34 minutes of the initial call to ESMS, fully authorised by the ESMS physician.
  • ESMS Scientific and medical teams were available immediately to support and provide clinical advice to the physician treating the patient in ITU.
  • SAE was fully documented and reported to the client PV dept within 24hrs of the event.
  • ESMS 24/7 global medical response service ensured the client’s commitment to patient safety and compliance with ICH -GCP regulations.

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