ICON Contributes to Major European Research Study That Aims to Improve Treatment for Traumatic Brain Injury
07 Novembro 2017 - 8:20AM
Business Wire
Recommendations from the longitudinal
observational research study will be presented today at the
European Parliament
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
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