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


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?

Get Insights on

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 We review meta analyses of published quantitative equivalence studies, and a newly published meta synthesis of unpublished cognitive interview studies on over 100 instruments performed by ICON.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.


Speakers Include:

Bill Byrom, PhD
Sr. Director Product Innovation, ICON

Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Outcomes. Bill contributes to the C-PATH ePRO Consortium and the eClinical Forum. He holds a PhD in disease simulation.

 

Willie Muehlhausen, DVM
Head of Innovation, ICON Clinical Research 

Willie has been involved in clinical research for more than 20 years and has held positions in Data Management, Clinical Research Operations and Project Management, Business Development and Product Management and Innovation. During his career he has specialised in developing new products and services for CROs and technology providers. He has represented the ePRO vendors as the inaugural Vice Chair of the ePRO consortium and overseen the development of important guidelines regarding the development and migration of questionnaires from paper to electronic formats.

Bryan McDowell
Global Program Lead, Digital Development, Novartis.

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.


Target Audience

  • Professionals working in the field of Outcomes Research e.g. PRO, ePRO, eCOA, COA.
  • Pharmaceutical clinical development.
  • All instrument authors and license holders 

Register today to gain new insights into equivalence testing methodology and implications for BYOD.