Icon updates MIRA in response to FDA guidance
The guidance by the US Food and Drug Administration (FDA) was issued in December and recommended an independent cardiovascular endpoints committee was established for Phase II, III and some IV diabetes trials.
Icon has done this and implemented an electronic system building on its MIRA (Medical Imaging Review and Analysis) technology platform to reduce the inefficiencies that are inherent when these committees rely on paper.
Jonathan Goldman, chief medical officer at ICON Medical Imaging, said: “ICON’s electronic adjudication solution provides the most secure and accurate method of defining true cardiovascular events in real-time.
“Because of its inherent regulatory compliance it is ideally suited to comply with the recent FDA guidelines for diabetes trials. It also provides significant savings in costs and timelines by preventing unnecessary enrolment of patients once the target number of endpoints has been achieved.”
The committees are being set up to adjudicate cardiovascular events, including cardiac death, acute myocardial infarction and stroke, in clinical trials of diabetes drugs.
Icon’s MIRA system will store information that could be relevant to adjudicating cardiovascular events. This includes case report forms, patient charts, laboratory results, echocardiogram, coronary angiogram, peripheral angiogram and x-rays.
Information contained within the system will be accessible remotely, enabling committee members to access and review the data from different locations.
