New Research from ICON Demonstrates Support for ‘Bring Your Own Device’ Approach in Clinical Trials
15 Junho 2016 - 4:00AM
Business Wire
Research shows that commonly-cited
equivalence and technical concerns around BYOD may not deter
adoption
ICON plc, (NASDAQ: ICLR) a global provider of drug
development solutions and services to the pharmaceutical,
biotechnology and medical device industries, today announced
research showing many pharmaceutical and clinical research
organisations (CROs) support the use of a ‘Bring Your Own Device’
(BYOD) approach in clinical studies, enabling patients to use their
own mobile devices to collect patient-reported outcomes (PRO) data.
The research highlights how commonly-cited concerns around the use
of patients’ own devices are not as much of a deterrent to adoption
as is often thought.
There are two main areas of concern in using a BYOD approach for
PRO data collection in clinical studies. The first relates to
equivalence and how different device sizes and operating systems
might affect the measurement properties of a PRO instrument. The
second relates to the technical and practical aspects of using a
patient’s own device, including data capacity, upgrades to
operating systems and a change of device mid-study, which could
negatively impact PRO data collection.
ICON’s research, completed in association with Medidata and
mProve Health, measured attitudes towards these perceived concerns
and provides industry with further information to devise future
strategies for BYOD adoption. The survey measured attitudes from 79
respondents from biopharma, CROs, ePRO providers, patient advocates
and research institutions.
The survey results found that biopharma and CRO professionals
appear to be significantly less deterred by challenges of
equivalence and the practical and technical challenges associated
with BYOD in clinical studies. Survey highlights include:
- Only 44% of respondents thought that
equivalence should be demonstrated on all possible devices used in
a BYOD study.
- The majority of respondents agreed that
demonstration of equivalence on a single device specification was
acceptable as long devices with smaller screen sizes or screen
resolutions could be prevented. Only 30% of respondents disagreed
with this approach.
- Over 75% responded that they were “not
at all concerned” or only “a little concerned” about issues such as
a PRO app being deleted, inadequate storage space for PRO data, or
the trial participant becoming distracted by other apps on their
device during PRO completion.
- Over half (53%) were not concerned that
people may be able to turn off notifications, such as diary
reminders, and 74% were not worried about trial participants
changing their phones mid-study.
“As a CRO that is at the forefront of innovating the clinical
trial process, we wanted to research industry perceptions towards
BYOD, an approach that has the potential to greatly enhance patient
engagement and compliance,” commented Willie Muehlhausen, ICON’s
Vice President eCOA and Head of Innovation. “We are encouraged by
the research findings which show support from biopharma and CROs
for the adoption of BYOD models. We will continue to investigate
this important area and work with industry partners and regulatory
authorities to provide evidence and guidance to make BYOD a fully
endorsed approach.”
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 89 locations in 37 countries and has approximately
12,200 employees. Further information is available at
www.iconplc.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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ICONMedia:Weber ShandwickCami Frederix, +44 (0)
207 067 0272CFrederix@webershandwick.com
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