|FDA reprimands tactics of principal investigator in clinical trial. Source: The Coghlan Group|
A cardiologist conducting a clinical trial has received a warning letter from the FDA for failing to get informed consent, enrolling the same patient twice and not maintaining acceptable case histories and drug disposition records.
Edward Mostel, MD, of Palm Beach Gardens Medical Center in Palm Beach, Fla., enrolled two patients in the trial before they signed informed consent forms, according to the warning letter, which was sent May 16 and posted to the FDA website this month.
In response to the FDA’s concerns, Mostel said that the informed consent documents may have been misdated, but the agency has rejected that assertion as “unacceptable.” The FDA added that a third patient’s consent form was not signed or dated by Mostel or any sub-investigator.
Mostel also acknowledged that a patient had been enrolled in the study twice but blamed the mistake on a sub-investigator. The agency also noted that Mostel was responsible for overseeing the study as its clinical investigator.
During the FDA’s investigation, conducted Oct. 17–31, 2007, the agency found that drug accountability records were missing for nine subjects between Oct. 13 and Dec. 5, 2005, according to the letter. Mostel responded that hospital records confirmed the subjects received the study drug according to protocol, but the agency’s letter stated that he provided no evidence to support that assertion.
The FDA said its “letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug.” However, the agency noted that it is Mostel’s responsibility “to ensure adherence to each requirement of the law and relevant FDA regulations. You must address these deficiencies and establish procedures to ensure that any ongoing or future studies will be in compliance with FDA regulations.”
The agency did not indicate the specific clinical trial, or the product being trialed.