Advancing Endpoints and Digital Health Technologies for Neurological and Neuromuscular Disorders: Workshop 1

On September 18^th, September 29^th, and October 10th, from 10:30 AM – 5:30 PM ET, NIH will be hosting a virtual workshop series: “Advancing Endpoints and Digital Health Technologies for Neurological and Neuromuscular Disorders.”

The registration information and draft agenda can be found here: https://advancingdigitalendpoints.com/agenda/.

Background: Digital endpoints are expected to revolutionize clinical trials by enabling real-world data collection with more granular longitudinal data, increasing participation of under-represented study participants, and improving participant engagement and retention. However, regulatory acceptance of endpoints used in clinical trials requires extensive fit for purpose validation and must be able to demonstrate that quantifiable changes in the endpoints reflect clinically meaningful changes in how participants feel, function, or survive.  Digital Health Technologies (DHTs), used to measure digital endpoints, include wearable sensors, mobile/app based cognitive or functional assessments, and in-home video analysis. Advancing DHT development and digital endpoint validation is expected to advance therapeutic development and improve patient care. Currently there are only a few neurological and neuromuscular conditions with active digital endpoint validation efforts underway, however there are many more conditions that could benefit from emerging technologies and collaborating on shared digital endpoint validation needs.

The goals of this workshop series are to:

1. help inform communities starting to develop digital endpoints about challenges, best practices and regulatory requirements,
2. increase researchers’ awareness of novel technologies that may be useful for measuring/developing new digital endpoints,
3. increase engineers/device developers’ awareness of potential opportunities to help meet the needs of various neurological conditions (new markets), and
4. provide an opportunity to increase collaboration between patient advocacy organizations, researchers, and device developers.

This workshop is being organized by NINDS, NICHD/NCMRR, NIA, NIAMS, and NIMH.