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Another Example of Lack of Oversight May 18, 2010

Posted by Michael Hamrell in Regulatory Thoughts.

In another example of problems with clinical study oversight, Pfizer Inc. recently received a Warning Letter citing the firm for failing to properly monitor the clinical investigation. According to the April 2010 letter, Pfizer’s monitoring failed to detect numerous cases of “…widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner…”. Study monitors were reportedly on site numerous times while the alleged overdosing occurred but failed to review and detect the problem. The overdosing was finally detected some months later by data management during a review of data submitted. Pfizer did acknowledge to the FDA the problem and reportedly took steps to correct this along with several other problems cited in the Warning Letter.

This is another example where the failure to adequately monitor a study led to signficant compliance and protocol problems that likely could have been prevented or captured earlier with a more vigilant monitoring program. I think this points out the current compliance focus of the FDA; when problems are detected at a study site in protocol execution, it can often be traced back to inadequate monitoring and oversight.



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