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Reflections on DHT development and data analysis

Regulatory Strategy and Analytical Considerations for Digital Health Technology Use

Organized By: Measuring What Matters 2021 Co-Chairs

Series Description
Digital health tools are increasingly being adopted to assess the efficacy of pharmaceutical intervention. However, the integration of these tools into a trial program is complex and involves a multi-step approach. This series will present work from pioneers in the field who have undertaken this process and will have them feedback on the approaches that worked, and those that did not. As part of this series, attendees will gain knowledge on how endpoint measures have been developed using digital health technologies, from the patient perspective, to analytic and clinical validation, through to regulatory interaction. Participants will learn from experts in the field in the form of case studies from real clinical trial work, and hear firsthand the successes, victories and tribulations that can befall the practical researcher in the regulatory space. Participants will also learn about potential analytic options both for determining the clinical validity of digital health technologies and interpreting treatment effects.

Intended Audience:
Digital health professionals, Pharmaceutical and Academic

Level of knowledge needed: Advanced

Audience Benefits:
This webinar will provide the audience with:
  • Case studies on the integration of digital health tools into clinical trial programs, including
    • Study design and protocol development
    • Logistics
    • Device considerations
    • Statistical analysis
    • Regulatory interaction
Learning Outcomes/Objectives:
At the end of this series, attendees will be able to:

  • Understand the considerations for deciding to implement a digital device into their trial research
  • Avoid pitfalls which may lead to a negative regulatory decision
  • Develop an endpoint measure from the information collected by a digital health tool
  • Understand how to conduct clinical validation with exciting emerging methodologies
  • Develop an analytical approach to testing the efficacy of a drug using digital health tools

This series includes the following webinars:

Webinar #1: Traversing the Last Mile for Regulatory Qualification of Sensor-derived Digital Endpoints
In this talk, we will outline what we believe to be gaps in the evidentiary requirements framework for regulatory qualification of sensor-derived digital endpoints. As a case study, we will walk through example measurements that are part of our Parkinson’s Suite of digital measures, and share our experiences when planning for analytical and clinical validation of these measures. We will further discuss areas in which we feel it would be beneficial to have stakeholders align on evidentiary requirements, and highlight the need for agreed-upon methods to address open questions around sensor-based DHTs.

  • Speaker: Ritu Kapur, PhD, Head of Clinical R&D | Head of Digital Biomarkers, Verily Life Sciences
  • Moderator: Jiat Ling Poon, PhD, Sr Director and Head of Patient Focused Endpoint and Measurement Capability Team, Eli Lilly and Co

Digital health technologies, such as daily completion electronic diaries, sensor based out-of-clinic tasks and continuous assessment through wearable sensors all generate a lot of data. Handling this data with our typical tools often leads to a loss of information which hide results. This session will discuss when it is appropriate to use traditional methods and when specific methods for intensive longitudinal data are required, and present these through worked examples.

  • Speaker: Pip Griffiths, Associate Director, IQVIA
  • Moderator: RJ Wirth, CEO, Vector Psychometric Group, LLC

  • ISOQOL members receive a discounted rate. To view membership rates, click  here.
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