The importance of an independent oversight committee to preserve treatment fidelity, ensure protocol compliance, and adjudicate safety endpoints in the ATACH II trial.

In response to growing trends and accepted U.S. Food and Drug Administration (FDA) guidance, the ATACH II trial leadership developed the independent oversight committee (IOC) as a mechanism to adjudicate the trial safety endpoints and to evaluate treatment fidelity and protocol compliance. To accomplish these tasks, the IOC reviews the first three subjects enrolled at each study center and all serious adverse events that occur across all study centers. The IOC makes recommendations to the steering committee regarding the aggregation of, or trend in, adverse events at particular sites and discusses homogeneity, or lack thereof, in the principles and intensity of the overall care. Based on the IOC findings, the steering committee will contact individual sites, as needed, to discuss potential remedial measures.