Draft clinical hold guidance designed to protect patients from "serious threats" to safety. (Clinical trials).

A newly-issued FDA draft guidance document describes when and how the agency can impose clinical hold procedures in situations involving clinical investigators who have committed serious violations or reported false data to study sponsors.

The draft guidance, titled "The Use of Clinical Holds Following Clinical Investigator Misconduct," details the circumstances under which FDA would consider imposing a clinical hold, the steps necessary to protect human subject before implementing a clinical hold and the criteria that must be met in order for the agency to lift a hold.

According to the Aug. 27 Federal Register notice, FDA has in place a system of enforcement that allows it to take a variety of actions against a clinical investigator who it deems has committed serious violations of FDA regulations. However, according to the draft guidance: "... These actions may not be completed swiftly enough to protect human subjects who may be at risk in ongoing studies conducted by the investigator." It continues: "Where the investigator's misconduct appears to pose an ongoing threat to the safety and welfare of such subjects, imposition of a full or partial clinical hold on ongoing or proposed studies of human drugs or biological products may be appropriate." …