ICON Delivers New Electronic Solution to Expedite Clinical Trial Adjudication
26 Janvier 2009 - 11:57AM
PR Newswire (US)
Enables Sponsors to Comply With Recent FDA Guidance on Diabetes
Trials DUBLIN, Ireland, January 26 /PRNewswire-FirstCall/ -- ICON
plc, (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of
outsourced development services to the pharmaceutical,
biotechnology and medical device industries, today announced the
launch of a new electronic solution that will accelerate the
adjudication of cardiovascular events in diabetes studies. The
evaluation of cardiovascular risk in diabetic trials has been the
subject of recent FDA guidance. Recommendations published in
December 2008 require sponsors to establish an independent
cardiovascular endpoints committee to adjudicate cardiovascular
events, including cardiac death, acute myocardial infarction and
stroke. FDA guidance applies to diabetes drugs evaluated in all
Phase II and Phase III trials and some Phase IV trials.
Historically, most of the adjudication performed by independent
adjudication committees has been done 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 currently being used in a number of
trials, allows cardiovascular event data to be uploaded, reviewed
and assessed online, delivering significant operational
efficiencies. Dr. Jonathan Goldman, MD, FACC, Chief Medical Officer
at ICON Medical Imaging commented: "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." ICON's new endpoint solution is a
fully validated module of the existing MIRA(TM) (Medical Imaging
Review and Analysis) technology platform, developed and managed by
ICON Medical Imaging. MIRA is a proprietary 21 C.F.R. Part 11
compliant system that provides functionality 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,
ECG, echocardiogram, Multi-Gated Acquisition Scan (MUGA), coronary
angiogram, peripheral angiogram and x-rays - in a digital DICOM
(Digital Imaging and Communications in Medicine) format.
Adjudicators in different locations can simultaneously access and
review this data in a secure 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 well as programmatic
identification of cases that require consensus resolution. Dr.
Didier Saur, MD, Vice President, Endocrinology & Metabolism at
ICON Clinical Research added: "This latest regulatory requirement
will make the clinical development of diabetes drugs more demanding
in terms of patient exposure and inclusion of patients at a higher
cardiovascular risk. Companies developing oral anti-diabetic drugs
can not only benefit from ICON's new technology solution but also
from the vast experience of ICON's diabetes and cardiology
specialists as well as the expertise of our Cardiac Scientific
Advisory 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 to
pharmaceutical, biotech and life science clients globally. The
team's extensive experience and expert guidance enables clients to
maximise the success of their medical imaging endpoints, supporting
their current research and development capabilities. ICON Medical
Imaging has managed over 260 imaging trials in oncology,
cardiovascular, CNS, medical devices and imaging agents. Further
information is available at http://www.iconmedicalimaging.com/
ICON/ICLR-G DATASOURCE: ICON plc CONTACT: Contacts: US, Carissa
Drew, Tel: +1-617-520-7070, Email:
Copyright