Remote ambulation monitoring enhances composite disability measurement in MS to deliver reduced trial sample size
- 1F. Hoffmann-La Roche Ltd., Basel, Switzerland
Abstract
In multiple sclerosis trials, event-based endpoints like the composite confirmed disability progression (cCDP) are often limited by infrequent in-clinic testing. We present a framework that converts high-frequency, remote smartphone-based gait assessments into progression events, and establishes a new composite endpoint that blends digital and clinical progression events. Evaluated in the Phase 3b CONSONANCE study (N = 667), this digitally enhanced endpoint reduced required trial sample size by 24.9% at Week 48 compared to the original cCDP. Furthermore, it achieved equivalent statistical power 24 weeks earlier (Week 72 vs Week 96), demonstrating potential to shorten trial observation periods by 25%. In conclusion, this framework provides a practical pathway to optimize clinical trial efficiency in MS and other neurological conditions, potentially reshaping the path to therapeutic innovation.
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BibTeX
@misc{festanti2026remote,
title = {{Remote ambulation monitoring enhances composite disability measurement in MS to deliver reduced trial sample size}},
author = {A. Festanti and D. Stanev and C. Simillion and J. Rodrigues and L. Leocani and A. Kazlauskaite and J. Overell and J. Lorscheider and G. Cutter and H. Butzkueven and L. Craveiro and M. D. Rinderknecht},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.03.26361524},
url = {https://www.medrxiv.org/content/10.64898/2026.09.03.26361524v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Remote ambulation monitoring enhances composite disability measurement in MS to deliver reduced trial sample size
AU - A. Festanti
AU - D. Stanev
AU - C. Simillion
AU - J. Rodrigues
AU - L. Leocani
AU - A. Kazlauskaite
AU - J. Overell
AU - J. Lorscheider
AU - G. Cutter
AU - H. Butzkueven
AU - L. Craveiro
AU - M. D. Rinderknecht
PY - 2026
DA - 2026/09/03
PB - medRxiv
DO - 10.64898/2026.09.03.26361524
UR - https://www.medrxiv.org/content/10.64898/2026.09.03.26361524v1
AB - In multiple sclerosis trials, event-based endpoints like the composite confirmed disability progression (cCDP) are often limited by infrequent in-clinic testing. We present a framework that converts high-frequency, remote smartphone-based gait assessments into progression events, and establishes a new composite endpoint that blends digital and clinical progression events. Evaluated in the Phase 3b CONSONANCE study (N = 667), this digitally enhanced endpoint reduced required trial sample size by 24.9% at Week 48 compared to the original cCDP. Furthermore, it achieved equivalent statistical power 24 weeks earlier (Week 72 vs Week 96), demonstrating potential to shorten trial observation periods by 25%. In conclusion, this framework provides a practical pathway to optimize clinical trial efficiency in MS and other neurological conditions, potentially reshaping the path to therapeutic innovation.
ER -