ICON Selected by the FDA to Validate Patient-Reported Outcome Endpoints for Antibacterial Drug Trials
February 20 2017 - 5:00AM
Business Wire
Research is being conducted in collaboration
with the FNIH Biomarkers Consortium
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 been awarded a project by the US Food & Drug
Administration (FDA) to validate three Patient Reported
Outcomes (PRO) instruments that will measure clinical endpoints in
antibacterial drug trials. The conditions in which the endpoints
will be validated are Acute Bacterial Skin and Skin Structure
Infections (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP)
and Hospital-Acquired Bacterial Pneumonia (HABP).
HABP is the second most common hospital-acquired infection and
is the primary cause of death in intensive care units; ABSSSI has
high rates of morbidity and other associated medical conditions
whilst CABP is a major cause of mortality and morbidity worldwide,
particularly among people over 65 years of age. Sponsors engaged in
clinical trials for these conditions are currently using different
methodologies to assess the primary endpoint as there is no
qualified PRO instrument.
ICON’s Clinical Outcomes Assessment (COA) group, in
collaboration with the Biomarkers Consortium of
the Foundation for the National Institutes of
Health (FNIH), will create an electronic platform to validate
key PROs, allowing investigators to assess the symptoms of ABSSSI,
CABP and HABP at various time points over the course of the
infection and measure the effects of antibacterial drugs. The PROs
will be implemented on CRF Health’s TrialMax® eCOA platform,
allowing patients to use the application on a handheld device
during the course of the trials. These PROs will continue to be
validated and developed in accordance with the FDA guidance for PRO
measures used to support labeling claims and will follow the Drug
Development Tool (DDT) Qualification Program.
The collaboration brings together scientists from ICON, FNIH,
the FDA, the National Institute of Allergy and Infectious Diseases,
the Infectious Diseases Society of America, pharmaceutical and
biotechnology companies and the academic research community, to
develop new approaches for evaluating the efficacy of antibiotics
in future clinical trials of therapies for ABSSSI, CABP and
HABP.
“This project builds on our previous work with the FDA and FNIH
to develop a new PRO measure for HABP trials and we’re proud to
continue our support in this area of great unmet need,” commented
Ramita Tandon, Executive Vice President, ICON Commercialisation
& Outcomes. “Bacterial infections are becoming harder to treat
as drug-resistant strains emerge at an increasing rate. ICON’s COA
group has extensive experience in all areas of outcomes research to
validate these important endpoints for antibacterial trials,
speeding up the drug development process and delivering effective
antibacterial medicines to patients.”
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 87 locations in 38 countries and has approximately
12,500 employees. Further information is available at
www.iconplc.com.
About the FNIH
The Foundation for the National Institutes of Health creates and
manages alliances with public and private institutions in support
of the mission of the NIH, the world’s premier medical research
agency. The Foundation, also known as the FNIH, works with its
partners to accelerate key issues of scientific study and
strategies against diseases and health concerns in the United
States and across the globe. The FNIH organizes and administers
research projects; supports education and training of new
researchers; organizes educational events and symposia; and
administers a series of funds supporting a wide range of health
issues. Established by Congress in 1996, the FNIH is a
not-for-profit 501(c)(3) charitable organization. Further
information is available at www.fnih.org
About the Biomarkers Consortium
The Biomarkers Consortium is a public-private biomedical
research partnership managed by the Foundation for the National
Institutes of Health (FNIH) that endeavors to develop, validate,
and/or qualify biological markers (biomarkers) to speed the
development of medicines and therapies for detection, prevention,
diagnosis and treatment of disease and improve patient care.
Further information is available at
www.biomarkersconsortium.org
About CRF Health
CRF Health is the leading provider of patient-centered eSource
technology and service solutions for the life sciences industry.
With experience in more than 800 trials, over 100 languages and
across 74 countries, CRF Health’s TrialMax® platform consistently
demonstrates the industry’s highest data accuracy, patient and site
compliance, and patient retention.
CRF Health’s eSource solutions improve trial engagement by
fitting into the lives of patients and seamlessly integrating into
sites to maximize protocol compliance. The integrated TrialMax®
platform includes eCOA solutions for collecting PROs (Patient
Reported Outcomes), ObsROs (Observer Reported Outcomes), ClinROs
(Clinician or Rater Reported Outcomes), and PerfOs (Performance
Outcomes), and features TrialConsent™, an electronic solution for
collecting informed consent in clinical trials. More information is
at http://www.crfhealth.com/
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.
ICON/ICLR-G
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ICON Media ContactWeber ShandwickCami FrederixTel: +44
(0)207 067 0272Email: cfrederix@webershandwick.com
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