FDA Sends PI Warning Letter For Not Checking Trial Participants’ Eligibility
April 27th, 2022 // 4:22 pm @ jmpickett
FDA sent a warning letter this month to a Georgia child neurologist because he enrolled clinical trial subjects into a study and an extension without ensuring they met clinical study criteria.
The FDA warning letter didn’t have the details of the study that was involved. But the warning letter was sent to Daniel Tarquinio, who is a child neurologist and founded the Center for Rare Neurological Disease. He has worked on several rare disease drug trials with Rett Syndrome Research Trust and Ultragenyx.
FDA told the PI how the agency found unacceptable clinical trial conditions at his site in a November 2021 inspection. It found that Tarquinio did not ensure the clinical investigation was done according to the investigational plan. Four clinical trial subjects were enrolled in an extension study that was open label. But each subject had been enrolled earlier and was participating in a trial with another drug.
The doctor explained to FDA that rare diseases sometimes allow there to be dual clinical trial enrollment. He also noted that before he enrolled patients, he tried to get the exclusion criteria clarified.
Tarquinio said that he did a root-cause analysis and CAPAs, which included writing better SOPS. For example, he said he strictly sticks to the trial protocol, such as comparing subject eligibility when he rolls subjects from one trial to another.
Further, he said he writes a clarification from the drug sponsor or possibly a protocol amendment if there is ambiguity. Tarquinio also said he sets up documentation practices for clinic meetings and phone calls.
However, the FDA warning letter said the doctor’s written responses were not sufficient because similar violations aren’t assured not to occur later. FDA also stated that it was only the research coordinator that has been adequately trained in revised and new SOPs. Also, several SOPs state they apply to all research personnel, which includes the doctor as the CI.
But there are no details that he and the staff have been properly trained, and they don’t offer details about when and how the coordinator received SOP training.
FDA noted it is especially worried about four test subjects who were placed in a clinical trial and then into an extension study without making sure they were eligible.
Tarquinio told the media this month that he didn’t correctly document a talk with a trial medical monitor in 2019 about exclusion criteria. By the time the matter came up with the drug sponsors, a new monitor was brought in. He stated that the new monitor wanted him to disenroll trial subjects from one research study and that was done in 2019.
The PI concluded that he put in several stop gaps that make it almost impossible for this problem to arise again.
