This one is very interesting so say the least, and it sounds like a software issue of sorts, not enough audit tables or was the data corrupted? Being a geek those are the questions that come to my mind when I hear the word “integrity” , but it may not be the issue at all. Who does the audits since it appears to be contracted? How data rich are they with business intelligence as relates to trials? Clinical trial data is a pretty complex and complicated reporting system these days. BD
The agency sent Johnson & Johnson and its partner, Basilea, a so-called complete response letter that mentions a bunch of problems, or what Basilea calls “specific deficiencies of study conduct.” In other words, the FDA wants additional audits of clinical trial sites for Ceftobiprole, a broad-based spectrum antibiotic to treat the deadly MRSA superbug.
What went wrong? There was a failure to ensure proper monitoring of the studies. And so the FDA wants info on clinical quality assurance programs and also asked for a new audit plan that addresses failures in monitoring by unnamed contract research organizations. In a statement, Basilea says the FDA is unable to review the clinical data until “issues of data integrity have been resolved.”