Overview

Title: The Template for a Successful Digital Trial

Date: Thursday, November 08, 2018

Time: 11:00 AM Eastern Daylight Time

Duration: 1 hour


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Summary

There is increasing interest in using mHealth technologies to design patient centric clinical trials. However despite the increasing availability of mHealth technologies that can successfully capture physiological data, and digital platforms that can ingest and analyze the data to date, the adoption of these technologies is a cautiously embraced in clinical research. The implementation of such technologies in clinical trials introduces new challenges that needs to be addressed for maximizing the expected value.

In this webinar Industry Leaders Marie Mc Carthy (ICON PLC) and Chen Admati (Intel) will explore a few best practices for implementing a successful digital trial, addressing the main concerns and challenges in the areas of:

  • Patient Engagement and Burden
    • How do you manage patient interaction with the technology in the home environment?
  • Device Suitability
    • With so many mHealth devices available how to select the technology that will capture the data required for your study.
  • Data Complexity and Insight Generation
    • How do you analyse data from devices capable of generating Terabytes of data during the course of a routine study.
  • Operationalization
    • What do study teams need to do to successfully deploy, train, monitor and reconcile device upon the completion of the study.
  • Privacy and Security Issues,
    • What is the impact of local privacy and security measures on global digital studies?
  • Regulatory Acceptance.
    • What strategies are required to ensure that data generated in a digital study can be used to support the clinical hypothesis?

Speakers

Marie McCarthy

Marie McCarthy
Senior Director, Innovation
ICON

Marie McCarthy is part of the multidisciplinary Innovation Team at ICON plc. Seen as a key Intrapreneur within the organisation she has specific responsibility for developing solutions in the direct to patient paradigm. Her focus is primarily on the use of wearables and sensors in clinical trials, with particular emphasis on the potential these devices have to monitor the physical behaviours of the digital patient. Ms McCarthy has a background in scientific research and has worked in a number of industries including IVD and Medical Devices. She is a published author and spoken at a number international conferences. She acts in an advisory capacity for a number of sponsors on the relevant clinical endpoints and considerations to be deployed when embarking on the incorporation of wearable technology into clinical trials. As part of the ICON CNS innovation group she provides insight into outcomes addressed by wearable technology. Within the Innovation team she has been directly responsible for the running of a number of proof-of-concepts including a number of multi-sensor studies. She has written and contributed to numerous articles focusing on use many of which are on the use of wearables in clinical trials.

Chen Admati

Chen Admati
Head of Intel® Pharma Analytics Platform
Intel

Chen Admati is the head of Intel® Pharma Analytics Platform at Intel. Intel® Pharma Analytics Platform is an edge-to-cloud artificial intelligence platform for remote monitoring of patients during clinical trials using wearable and sensors. Using big data and machine learning techniques, the platform enables to quantify the impact of therapies, promise to transform research and drug development in various chronic diseases. Prior to leading Intel® Pharma Analytics Platform, Ms Admati managed various artificial intelligence solutions and services in various domains. She is AI professional, brings vast of understanding in the healthcare domain, and how to successfully digitize clinical trials.