ICON, the international contract research organisation (CRO) based in Dublin, Ireland, has launched an electronic solution to help sponsors manage more stringent regulatory requirements for diabetes trials in the US.

Specifically, the new module developed from ICON’s existing MIRA (Medical Imaging Review and Analysis) technology platform addresses the guidance issued last December by the US Food and Drug Administration, recommending that companies with pipeline drugs or biologics for type 2 diabetes should provide evidence from Phase II and III trials that the therapy does not aggravate the risk of cardiovascular events such as heart attacks.

The guidance reflected growing concern about the safety profile of marketed diabetes treatments, in particular GlaxoSmithKline’s Avandia (rosiglitazone). As ICON points out, the FDA’s recommendations call on trial sponsors to establish an independent cardiovascular endpoints committee to adjudicate cardiovascular events, including cardiac death, acute myocardial infarction and stroke.

Historically, the CRO adds, most of the work done by independent adjudication committees has been in a paper-based environment, “causing inefficiencies in project tracking and data evaluation, auditing challenges and increased costs associated with adjudicator travel, shipping and unnecessary patient enrolment”.

ICON's new electronic solution, which is already in use in a number of clinical trials, allows cardiovascular event data to be uploaded, reviewed and assessed online. According to Dr Jonathan Goldman, chief medical officer at ICON Medical Imaging, the module “provides the most secure and accurate method of defining true cardiovascular events in real-time”.

Because of its “inherent regulatory compliance”, the solution “is ideally suited to comply with the recent FDA guidelines for diabetes trials”, Goldman says. “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 MIRA system is used for imaging and clinical data management, image analysis, project management and document management. The new endpoint module stores all data relevant to the adjudication of cardiovascular events – including Case Report Form (CRF) output, patient charts, laboratory results, x-rays and data from electrocardiograms, echocardiograms, Multi-Gated Acquisition Scans, coronary angiograms and peripheral angiograms – in a digital DICOM (Digital Imaging and Communications in Medicine) format.

Adjudicators in different locations can simultaneously access and review the data in a secure online environment and complete the assessment in an electronic CRF.