Title: What's Next in eCOA? - New insights into equivalence testing methodology and implications for BYOD

Date: Thursday, November 16, 2017

Time: 04:00 PM Greenwich Mean Time

Duration: 1 hour

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Due to significant improvements in the integrity, quality and timeliness of data collected, there are a growing number of clinical trials employing electronic media (especially smartphones and tablets) to collect patient-reported outcomes (PROs). Because many PRO instruments were developed and validated on paper, care is needed when migrating them to electronic formats (ePRO) to ensure the measurement properties of the instrument are unchanged, and that the electronic version is easy to use in the target group of patients. In 2009, the ISPOR ePRO Good Research Practices Task Force published recommendations on the evidence needed to support measurement equivalence when migrating from paper to electronic formats, which included cognitive interview and usability testing (minor modifications due to migration) and quantitative equivalence studies (moderate changes). These recommendations have been largely adopted by the industry and regulators. However, over the 8 years since their publication, accumulating evidence has indicated that instrument measurement properties are generally well conserved when instruments are migrated to electronic forms where ePRO design best practice is followed. Does this mean that a qualitative or quantitative study may not always be needed when implementing ePRO?

In this webinar, we review the accumulating evidence to support measurement equivalence of instruments when migrated to ePRO. We review meta analyses of published quantitative equivalence studies, and a newly published meta synthesis of unpublished cognitive interview studies on over 100 instruments performed by ICON. These meta analyses provide strong evidence that the measurement properties of instrument migrations that follow ePRO design best practice are unaffected by migration from paper to electronic formats, and provide greater insights to the definition of migration best practice. While this provides support for the use of bring your own device (BYOD) where instrument properties on mobile device models cannot be tested a priori, we also present new results from the industry’s first definitive BYOD quantitative equivalence study, where we assessed instrument measurement properties between paper, BYOD and provisioned devices. We will propose how the results of this study can be generalized to provide support for the use of BYOD in regulatory submission studies.


Bill Byrom

Bill Byrom, PhD.
Senior Director of Product Innovation,
ICON Clinical Research

Bill serves as Senior Director within Product Innovation at ICON Clinical Research, focussing on harnessing new technologies within clinical trials, and has worked within the Pharmaceutical Industry for over 25 years. Bill is an industry thought leader in the area of eClinical technologies and is the author of over 70 publications including a leading industry textbook on electronic Patient Reported Outcomes. Bill is the Vice Director of the Critical Path Institute’s ePRO Consortium where he helps to steer cross-industry activity related to the use of electronic solutions to collect patient reported outcomes data. He is also working to operationalize the use of mobile and wearable device technology in clinical trials conducted by ICON.

Willie Muehlhausen

Willie Muehlhausen, DVM
Vice President, Product Innovation,
ICON plc

Willie leads ICON´s Innovation team and he has been researching eCOA and instrument migrations for the last 5 years. Willie has worked in the clinical trial industry for more than 20 years and held various positions in technology companies and CROs in Germany, UK, US and Ireland. He has been a founding member of the ePRO Consortium and regularly presents at industry events on Innovation topics.

Bryan McDowell

Bryan McDowell
Global Program Lead, Digital Development, Portfolio, Strategy & Innovation (PS&I), Novartis Pharma AG

Bryan joined Novartis in 2001 and has worked in a variety of different roles within clinical development, business development & strategy and leading multiple innovative projects. Throughout this time, he has identified and pushed for the greater use of technologies within clinical development and trials to make drug development smarter and to reduce patient, site and sponsor burden while improving data quality – ultimately helping to deliver innovative medicines to patients faster. His current position as Global Program Lead for Digital Development brings him to the forefront of disruption innovation in clinical trial and drug development methodology.

Bryan holds a bachelors in biotechnology from Dublin City University and an MBA from the University of Wales.