FDAnews Device Daily Bulletin

Unplanned Unmasking in Trial Cited in Warning Letter

March 7, 2008
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In a SyntheMed clinical trial, an evaluation that should have been given by a blinded surgeon was performed by the same person responsible for the initial surgery and randomization of trial participants, according to a recent FDA warning letter.

Therefore, the surgeon was not blind to the randomization, the letter said. Although the name of the product is redacted, the letter noted that the study design requires a cardiac surgeon, masked to the randomization assignment, to assess the severity of adhesions at the investigational surgical site.

In its response, SyntheMed said the clinical investigator was reminded in 2005 that, according to the protocol, the surgeon performing the surgery could not conduct the assessment.

The response said in the future, monitors will be trained to ensure that when protocol violations occur, an appropriate corrective action plan will be used to prevent further violations. The FDA found the response inadequate as it does not include a written plan for reporting protocol deviations.

The company did not respond to a request for comment by press time. The warning letter can be seen at www.fda.gov/foi/warning_letters/s6673c.pdf.