Traversing the Last Mile for Regulatory Qualification of Sensor-derived Digital Endpoints
Organized By: Measuring What Matters 2021 Co-Chairs
Organized By: Measuring What Matters 2021 Co-Chairs
Description
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.
Intended Audience
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.
Intended Audience
- Digital health professionals
- Pharmaceutical
- Academic
Advanced
Audience Benefits
This webinar will provide the audience with:
- A hypothetical case study outlining the open questions that arise when taking a digital measure through the DDT qualification process
- A discussion from experts about the known and unknown aspects of the DDT qualification process in general
- A robust discussion of the gap between where the DDT qualification process and its guidelines are now, and how it could evolve to better facilitate researchers aiming to help patients. .
At the end of this webinar, attendees will be able to:
- Understand the knowns and unknowns of the DDT qualification process.
- Outline the areas of DHT development where gray areas still exist that have impact on DHT development
- Better prepare themselves for including DHT’s in their own patient centered research by building on the learnings of others in the field.
Presenter: 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
Sponsored by:
Recording Policy
Photography, video or audio recording (including screen capture) of ISOQOL courses, sessions, digital materials, or ISOQOL graphics without written permission from ISOQOL is strictly prohibited.
Note that photographs and video recordings taken by or on behalf of ISOQOL is the property of ISOQOL.
*This webinar is also available in a series.
*ISOQOL members receive a discounted rate. To view membership rates, click here.