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

1. Initial contact

ESMS received a call at 10:57am from a study coordinator in Belgium, about a patient who was participating in a randomised, double-blind, placebo-controlled, phase III study investigating treatment of head and neck squamous cell carcinoma. The patient had been admitted to an intensive treatment unit (ITU) that day with worsening pneumonia. Their treating physician had requested that the patient was unblinded, as they believed the pneumonia may be related to the study treatment. The study coordinator stated that the treatment given to the patient would differ depending on whether they were receiving the investigational medicinal product (IMP) or placebo. However, they did not know which treatment the physician was intending to administer.

2. Our analysis of the situation

The ESMS Information Scientist (IS) reviewed the study protocol and Investigator’s Brochure, and discussed the following information with the study coordinator:

  • Pneumonia has been reported as an adverse event previously during studies involving this IMP
  • Restricted concomitant treatments included additional experimental treatments and erythropoietin
  • Caution should be exercised when combining the IMP with P-glycoprotein modulators

Based on this information, it was confirmed that it may not be necessary to unblind the patient. This would depend on the specific treatments the physician wanted to administer.

3. Liasion with the clinicians

The IS requested that the treating physician call ESMS to further discuss the patient’s treatment. The treating physician called ESMS at 11:14am and discussed the case with the ESMS physician. They confirmed that the patient had already been treated with methylprednisolone, moxifloxacin and clarithromycin for interstitial pneumonitis.

From the study documentation, the IS confirmed that administration of clarithromycin (a potent P-glycoprotein inhibitor) may increase exposure to the IMP. Upon authorisation by the ESMS physician, the patient was successfully unblinded at 11:30am and the treatment allocation was relayed to the caller.

The SAE was fully captured and reported to the Sponsor Pharmacovigilance within 24 hours. An enquiry report was provided to the client within 24 hours for oversight. The report documented that the patient had been unblinded, but no details of the treatment allocation they were receiving were revealed.

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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