The use of electronic clinical outcome assessments (eCOA) is surging in clinical trials. Despite this trend, there is still some hesitation to embrace eCOA for fear that building an electronic version of an existing COA may “break” an instrument’s psychometric properties.

Fortunately, regulatory guidance and industry best practices have helped researchers to ensure modification to validated COAs when migrated to electronic platform has not undermined the instruments’ measurement properties. Guidance documents recommend mode equivalence studies of varying levels of complexity and associated cost, dependent on the extent to which an instrument is “changed” when migrated to a different mode of administration. The recommended studies can be expensive and time-intensive– requiring recruitment of 10-75 patients and up to 6-9 months to design, execute and analyze the study data.

In recent literature, eCOA experts suggested that mode equivalence testing may be eliminated for instruments that require only minor modifications when migrated to a new mode of administration, provided industry best practices for faithful migration are followed and the resulting screens undergo expert screen review. This webinar will discuss the current regulatory climate as well as the process of expert screen review, a new and less expensive practice for ensuring psychometric equivalence of instruments migrated to a new platform when only minor changes are required. Special considerations for Bring Your Own Device (BYOD) studies will be discussed.

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Speakers

Celeste A. Elash, Director, eCOA Sciences, YPrime

Celeste A. Elash is an eCOA industry expert with deep expertise in instrument development and eCOA solution development and implementation. She currently represents YPrime on the Critical Path Institute’s ePRO Consortium and has contributed to the development of industry best practices for faithful migration of COAs to electronic platform. Throughout her 25-year industry career, Celeste has served as a clinical research scientist, with a variety of contributions for the advancement of patient-focused drug development and eCOA adoption. Prior to joining YPrime, Celeste served as an independent consultant to biopharmaceutical companies and clinical science advisor for two eCOA providers. She has also done clinical research for Purdue University, The University of Pittsburgh and Western Psychiatric Institute and Clinic. Her experience spans more than 200 domestic and global clinical trials, academic research projects, and qualitative research projects.

In her current position as Director of eCOA Sciences, Celeste is responsible for developing YPrime’s scientific expertise for eCOA and advises Pharmaceutical Industry Sponsors on the implementation of industry and regulatory best practices in studies using eCOA. She is passionate about contributing to the development of safer and more efficacious treatments for patients.

Message Presenter

Willie Muehlhausen, Safira Clinical Research

Willie Muehlhausen, Managing Director, Muehlhausen Ltd.

Willie Muehlhausen is a successful serial intrapreneur with more than 20 years of experience in clinical research and clinical trial technologies. Willie led ICON’s Innovation team for more than five years and initiated and supported research and implementation projects in wearable devices, machine learning, artificial intelligence, electronic Clinical Outcome Assessments, crowdsourcing and innovation strategy. Willie has been involved in more than 40 publications and has co-authored two books on eCOA. His achievements have been recognized by his industry peers with the inclusion in PharmaVoice100 in 2015 and in the Centerwatch Top20 Innovators in 2018.

Message Presenter

Who Should Attend?

eCOA/ePRO Specialists, plus senior professionals working within:

HEOR
PCOR
Clinical Operations
Data Management
eClinical Technologies
Regulatory Affairs
Outsourcing & Procurement

What You Will Learn

Attendees will hear about:

Trends in clinical outcome assessments: eCOA
Overview of the regulatory climate
Mode equivalence testing compared to expert screen review
Special considerations for BYOD studies

Xtalks Partner

YPrime

YPrime offers more than a decade of focused work with eclinical systems to expedite and improve the quality of patient management, clinical supplies, drug accountability and clinical data. Cloud-based interactive response technology (IRT) and electronic clinical outcome assessment (eCOA) platforms offer sponsors greater speed, precision and integration in clinical trial management.

Our data services and tools help sponsors bring together fragmented clinical research data into contextual information they can act on. YPrime’s technology and service offerings enable sponsors to move faster and more efficiently to their next development milestone.