News Release

Research shows that commonly-cited equivalence and technical concerns around BYOD may not deter adoption

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 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.

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ICON
Media:
Weber Shandwick
Cami Frederix, +44 (0) 207 067 0272
CFrederix@webershandwick.com

Source: ICON plc

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