Recommendations from the longitudinal observational research study
will be presented today at the European Parliament
DUBLIN--(BUSINESS WIRE)--
ICON plc, (NASDAQ: ICLR) a global provider of drug development
solutions and services to the pharmaceutical, biotechnology and medical
device industries, today announced that it has contributed to a complex
pan-European traumatic brain injury (TBI) research study involving over
4,500 patients in 65 sites in 20 European countries. ICON provided site
management and source data verification (SDV) services to the study,
which was supported by the European Union and led by Professor Andrew
Maas from the University Hospital Antwerp (Belgium) and Professor David
Menon from the University of Cambridge (UK). ICON's Dr. Valérie Legrand,
VP Project Management and a recognised expert in CNS, also provided
clinical expertise as a member of the project's Management
Committee. The Lancet
Neurology Commission on TBI is being launched at the European
Parliament today and will set out clinical and research priorities and
recommendations to address the varied challenges in TBI.
In the European Union, 2.5 million people suffer a TBI each year of
which 57,000 patients die. TBI is also the leading cause of death and
disability in young adults and the incidence in elderly patients is also
increasing. Treatment for TBI is challenging and large variations exist
between countries which led to a global TBI initiative involving
research projects in the Europe, the US, Canada, Australia, China and
India. CENTER-TBI
is the European longitudinal observational research study that combines
the expertise of over 150 international clinicians and researchers.
From December 2014 to October 2017, almost 4,500 patients enrolled in
the study at 65 sites in 20 European countries. ICON deployed both
remote and onsite monitoring services and performed SDV on a pre-defined
sub-set of key patient data points, which in the course of the study
amounted to verification of over 13,000 data points.
The Commission
on TBI, published today in The
Lancet Neurology, identifies 12 key recommendations and policies to
improve the prevention, quality of care and clinical research in TBI. It
seeks to identify strategies to better characterise TBI, increase
prognostic accuracy, and adopt a more precision-medicine approach to
treatments. The Commission also promotes the use of new tools for
clinical evidence generation and implementation, so that research
outputs can be more rapidly integrated into clinical care. Moreover, it
highlights the importance of international collaboration of funding
agencies and researchers to provide a global response to reduce the
individual and societal burden of TBI.
"The need to improve prevention and clinical care in TBI is huge,"
commented Professor Andrew Maas, Project Coordinator, CENTER-TBI. "The
international collaborations between funding agencies and researchers
combined in the InTBIR
initiative is unparalleled and offer a great opportunity to pioneer
new approaches to research, including the creation of a "living evidence
base". The involvement of ICON in the European CENTER-TBI study has been
fundamental in managing this large study across so many different
countries and in ensuring quality control of CENTER-TBI. All partners
are, however, equally important: CENTER is a team effort, characterized
by collaboration, data sharing and group authorships. The recruitment to
CENTER-TBI is nearly complete, and we are proceeding to the analysis
phase with results expected in 2018."
"ICON is proud to have contributed to such an important research project
to advance the diagnosis, treatment and care of patients with TBI,"
commented Dr. Valérie Legrand. "TBI is a highly complex and
heterogeneous condition which has hindered the development of new
treatments. The CENTER-TBI research project, together with the other
large global research international programmes, will help healthcare
professionals, patient organisations, policy makers and funding agencies
to better understand TBI which will result in more targeted treatments
and better overall patient care."
About CENTER-TBI
CENTER-TBI is a large European project that aims to improve the care for
patients with Traumatic Brain Injury (TBI). Led by Professor
Andrew Maas (Antwerp University Hospital and University of Antwerp,
Belgium) and Professor David Menon (University of Cambridge, UK), it
combines the expertise of over 150 international clinicians and
researchers, many of whom are part of the International Initiative
for Traumatic Brain Injury Research (InTBIR) More information on
CENTER-TBI is available at https://www.center-tbi.eu/
About ICON plc
ICON plc is a global provider of drug development solutions and services
to the pharmaceutical, biotechnology and medical device industries. The
company specialises in the strategic development, management and
analysis of programs that support clinical development - from compound
selection to Phase I-IV clinical studies. With headquarters in Dublin,
Ireland, ICON currently, operates from 97 locations in 38 countries and
has approximately 13,100 employees.
Further information is available at www.iconplc.com/cns
ICON/ICLR-G
This press release contains forward-looking statements. These
statements are based on management's current expectations and
information currently available, including current economic and industry
conditions. These statements are not guarantees of future performance or
actual results, and actual results, developments and business decisions
may differ from those stated in this press release. The forward-looking
statements are subject to future events, risks, uncertainties and other
factors that could cause actual results to differ materially from those
projected in the statements, including, but not limited to, the ability
to enter into new contracts, maintain client relationships, manage the
opening of new offices and offering of new services, the integration of
new business mergers and acquisitions, as well as economic and global
market conditions and other risks and uncertainties detailed from time
to time in SEC reports filed by ICON, all of which are difficult to
predict and some of which are beyond our control. For these reasons, you
should not place undue reliance on these forward-looking statements when
making investment decisions. The word "expected" and variations of such
words and similar expressions are intended to identify forward-looking
statements. Forward-looking statements are only as of the date they are
made and we do not undertake any obligation to update publicly any
forward-looking statement, either as a result of new information, future
events or otherwise. More information about the risks and uncertainties
relating to these forward-looking statements may be found in SEC reports
filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are
available on the SEC's website at http://www.sec.gov.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171107005820/en/
ICON Press Office Enquiries
Weber Shandwick
Olivia
Pimenta
Email: LDNWSWICONClinical@corp.ipgnetwork.com
Source: ICON plc
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