ICON launches electronic system for clinical trial adjudication
31 January 2009
ICON plc, (NASDAQ: ICLR; ISIN:IE0005711209) has 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 system, 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 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."
ICON's new endpoint solution is a fully validated module of the
existing MIRA (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 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."
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