Clinical Investigator’s Protocol Deviations Lead to FDA Warning Letter

The FDA is faulting a clinical investigator for neglecting to follow the established procedures for a trial testing a new investigational drug.

An FDA warning letter issued Tuesday states that North Hill Medical Research’s clinical investigator John Gabriel failed to adhere to an FDA-approved protocol for the trial.

Agency investigators noted that Gabriel randomized patients in a clinical trial without verifying that they met the inclusion criteria, which included taking a recent sample of patients’ serum creatinine — a waste product in the blood that comes from muscle activity — and an estimate of their glomerular filtration rate.

Gabriel randomized 25 patients before receiving their serum creatinine values, according to the letter. One patient who received the investigational drug later reported serum creatinine and eGFR values below the enrollment criteria level.

“This subject should never have been enrolled in the study,” the FDA wrote. Two other patients in the study required dosages to be lowered, after being overdosed because the clinical investigator had relied on subject-reported kidney history to assign doses.

The FDA also cited Gabriel for not adjusting the dosage of a patient who demonstrated a reduction in renal function, as the protocol requires.

In response to the agency’s complaints, Gabriel acknowledged the deviations in protocol and stated that the clinical staff has been retrained to follow the appropriate procedures.

The allegations stem from a February inspection of the company’s facility North Hill, Texas.

The institution did not respond to a request for comment.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of GMPs and the Quality Systems Regulation — information you need to stay in compliance.