Clinical Investigator Gets FDA Warning Letter for Protocol Deviations

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

Agency investigators said 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.