Clinical Investigator In FDA Hot Water for Not Opening Mail

Clinical Investigator In FDA Hot Water for Not Opening Mail

November 16th, 2011 // 2:13 pm @

When doctors and researchers sign up to participate in a clinical trial, they are expected to do a few basic things. Among them is keeping up to date with the clinical trial doings. One way to accomplish this is to open the mail. But not everyone does. As a result, one investigator was forced to admit that she had no idea what was going on. And the FDA did not like this one bit.

Why? Well, the FDA met earlier this year Leslie Diaz to review her participation in a pair of clinical trials and in a recently issued warning letter noted that the doctor, essentially, let these studies run on auto pilot. In a written affidavit, she acknowledged responsibility for “a number of significant instances of inadequate oversight and supervision,” according to the agency.

How inadequate? Well, Diaz found letters that she never opened and others she had not previously seen from trial monitors, sponsors and institutional review boards. And so had no idea that approval of audited protocols were either suspended or terminated – because she failed to respond to earlier letters or submit required review reports.

“I had no knowledge of how these studies were monitored,” she confessed. “I am also admitting to having ignored the clinical trials. I also did not keep track of the mail as far as what was coming in or going out.” She also acknowledged that all study documentation ended in December 2007, after her study coordinator left. Clinical trial? What clinical trial?

But there is more. A trial protocol also required that any serious adverse experience, including death due to any cause, that occurs to any patient in the study or within 14 days following the end of treatment or within an established follow-up period – whether or not related to the drug – must be reported to the sponsor within 24 hours, according to the FDA letter.

But Diaz must be forgetful. One subject was enrolled in the study on March 2, 2007, and records show that between May and early June 2007, when the subject underwent cardiac catheterization that revealed a serious adverse event requiring surgery. Diaz characterized this as “immediate[ly] life-threatening” on the sponsor adverse event reporting form. Yet, she did not report this to the trial sponsor until July 30, 2007. Hmm.. 24 hours turned into something like 50 or so days.

One more thing. In her affidavit, Diaz also acknowledged that, while searching for documentation for the audited studies, she found a box of meds that were used in the trial. These had never been returned to the sponsors, and the box contained full, partially full and empty bottles. As you know, such things are not supposed to be lying around where they can do harm.

After these experiences, Diaz informed the FDA that she will no longer participate in running clinical trials. We shall see. For now, the agency wants her to put in writing any and all steps she plans to take to avoid repeats. Our simple advice – open your mail and learn to tell time.


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