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Wednesday, June 23 • 1:00pm - 4:00pm
033P: #033P: eCOA 102: Beyond the Basics - Operational, Scientific, and Best Practices for eCOA and Wearable Devices in Clinical Trials

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Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-512-L04-P; CME 2.75; IACET 2.75; RN 2.75

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Capturing clinical outcome assessment data electronically (eCOA) brings many benefits over traditional paper-based methodologies. However, uncertainty and barriers to adoption still remain. This may be due to challenges with poor experiences during study start-up, conduct or close out, absence of clear definitions of roles and responsibilities among sponsors and providers, and misalignment of expectations among all stakeholders. Scientific and regulatory thinking, particularly in relation to issues of translation of measures and comparability of modes of data collection, can also create significant confusion, not helped by the fact that recommendations relating to these topics are evolving over time. Finally, a whole new area of technology-driven outcomes, namely those supported by mobile sensors and wearable devices, is emerging, raising a host of new questions and challenges for study teams.

Topics covered include:
  • The benefits and basics of eCOA
  • Best practices for the implementation, deployment, and operations of eCOA from provider and sponsor perspectives
  • Introduction to the Getting Better Together Initiative
  • Defining roles and responsibilities in an eCOA study
  • Five phases of an eCOA study
  • Operational best practices
  • Scientific and regulatory principles underlying eCOA data
  • Faithful Migration
  • Translation
  • Comparability between modes of data collection
  • Bring Your Own Device
  • Wearables and mobile sensors
  • Important considerations during sensor or wearable selection
  • Preparing a protocol for the logistics of using a wearable device
  • Choosing the right wearable measurement
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Who should attend?

This short course is designed for individuals in the clinical operations, data science, outcomes research, data management, eCOA, mobile or sensor technologies and innovation groups at biopharmaceutical companies who are considering, or have begun, collection of eCOA and/or wearable data in clinical trials. eCOA provider staff and developers new to the field would also benefit from this course.

Learning Objectives

Describe best practices for implementation, deployment, and operations of eCOA studies; Discuss scientific and regulatory principles underlying eCOA data capture and the evolving thinking relating to translation and comparability between modes of data collection; Discuss the emerging science of wearables/mobile sensors, and how to get the most out of these data to support trial endpoints.

avatar for Estelle Haenel

Estelle Haenel

Medical Director, Kayentis, France
avatar for Paul O'Donohoe

Paul O'Donohoe

Senior Director, eCOA Product and Science, Medidata Solutions, United States
Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata's electronic clinical outcome assessment technologies, and supporting internal... Read More →
avatar for Jeremy Wyatt

Jeremy Wyatt

CEO, ActiGraph, United States
Jeremy Wyatt is the CEO of ActiGraph, a leading provider of motion-sensing wearable technology solutions for pharmaceutical and academic research. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective... Read More →
avatar for Katherine Zarzar

Katherine Zarzar

Head of Agile Execution, Patient-Centered Outcomes Research, Genentech, A Member of the Roche Group, United States
Kate Zarzar is a Principal PCOR Scientist and Head of Agile Execution focused on designing and delivering COA strategies at Roche. As head of Agile Execution, she focuses on leveraging agile methodology to improve how the business executes paper COA and eCOA strategies to generate... Read More →

Wednesday June 23, 2021 1:00pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Tutorial |   19: Short Courses, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial