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The evaluation of cardiovascular risk in diabetic trials has been thesubject of recent FDA guidance. Recommendations published in December 2008require sponsors to establish an independent cardiovascular endpointscommittee to adjudicate cardiovascular events, including cardiac death, acutemyocardial infarction and stroke. FDA guidance applies to diabetes drugsevaluated in all Phase II and Phase III trials and some Phase IV trials.Historically, most of the adjudication performed by independent adjudicationcommittees has been done in a paper-based environment, causing inefficienciesin project tracking and data evaluation, auditing challenges and increasedcosts associated with adjudicator travel, shipping and unnecessary patientenrolment. ICON's new electronic solution, which is currently being used in anumber of trials, allows cardiovascular event data to be uploaded, reviewedand assessed online, delivering significant operational efficiencies.
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Dr. Jonathan Goldman, MD, FACC, Chief Medical Officer at ICON MedicalImaging commented: "ICON's electronic adjudication solution provides the mostsecure and accurate method of defining true cardiovascular events inreal-time. Because of its inherent regulatory compliance it is ideally suitedto comply with the recent FDA guidelines for diabetes trials. It alsoprovides significant savings in costs and timelines by preventing unnecessaryenrolment of patients once the target number of endpoints has been achieved."
ICON's new endpoint solution is a fully validated module of the existingMIRA(TM) (Medical Imaging Review and Analysis) technology platform, developedand managed by ICON Medical Imaging. MIRA is a proprietary 21 C.F.R. Part 11compliant system that provides functionality for imaging and clinical datamanagement, image analysis, project management and document management. Thenew endpoint module stores all data relevant to the adjudication ofcardiovascular events - including Case Report Form (CRF) output, patientcharts, laboratory results, ECG, echocardiogram, Multi-Gated Acquisition Scan(MUGA), coronary angiogram, peripheral angiogram and x-rays - in a digitalDICOM (Digital Imaging and Communications in Medicine) format. Adjudicatorsin different locations can simultaneously access and review this data in asecure online environment and complete the assessment in an electronic CRF.The CRF is logic driven and can also allow for queries for extra data as wellas programmatic identification of cases that require consensus resolution.
Dr. Didier Saur, MD, Vice President, Endocrinology & Metabolism at ICONClinical Research added: "This latest regulatory requirement will make theclinical development of diabetes drugs more demanding in terms of patientexposure and inclusion of patients at a higher cardiovascular risk. Companiesdeveloping oral anti-diabetic drugs can not only benefit from ICON's newtechnology solution but also from the vast experience of ICON's diabetes andcardiology specialists as well as the expertise of our Cardiac ScientificAdvisory Board."
About ICON Medical Imaging
Located in Warrington, PA, ICON Medical Imaging, a division of ICON plc,is the leading provider of Medical Imaging core laboratory services topharmaceutical, biotech and life science clients globally. The team'sextensive experience and expert guidance enables clients to maximise thesuccess of their medical imaging endpoints, supporting their current researchand development capabilities. ICON Medical Imaging has managed over 260imaging trials in oncology, cardiovascular, CNS, medical devices and imagingagents.
Further information is available at http://www.iconmedicalimaging.com
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SOURCE ICON plc
