{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "F. Hoffmann-La Roche Ltd., Basel, Switzerland"
  ],
  "article_type": "PUBLISHAHEADOFPRINT",
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
      "name": "A. Festanti"
    },
    {
      "name": "D. Stanev"
    },
    {
      "name": "C. Simillion"
    },
    {
      "name": "J. Rodrigues"
    },
    {
      "name": "L. Leocani"
    },
    {
      "name": "A. Kazlauskaite"
    },
    {
      "name": "J. Overell"
    },
    {
      "name": "J. Lorscheider"
    },
    {
      "name": "G. Cutter"
    },
    {
      "name": "H. Butzkueven"
    },
    {
      "name": "L. Craveiro"
    },
    {
      "affs": [
        0
      ],
      "name": "M. D. Rinderknecht"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/e0t97cpcxa0dw.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.09.03.26361524",
  "fulltext_url": "https://www.medrxiv.org/content/10.64898/2026.09.03.26361524v1.full",
  "id": "e0t97cpcxa0dw",
  "issns": [],
  "landing_url": "https://www.medrxiv.org/content/10.64898/2026.09.03.26361524v1",
  "language": null,
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "medrxiv",
      "neurology"
    ],
    [
      "openalex",
      "2734|Multiple Sclerosis Research Studies"
    ]
  ],
  "openalex": "W7211974990",
  "pdf_url": "https://www.medrxiv.org/content/10.64898/2026.09.03.26361524v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-09-03",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/e0t97cpcxa0dw.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:54Z",
      "native_id": "10.64898/2026.09.03.26361524",
      "source": "medrxiv",
      "url": "https://www.medrxiv.org/content/10.64898/2026.09.03.26361524v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "medrxiv:neurology",
      "subfield": "neurology"
    }
  ],
  "title": "Remote ambulation monitoring enhances composite disability measurement in MS to deliver reduced trial sample size",
  "title_text": "Remote ambulation monitoring enhances composite disability measurement in MS to deliver reduced trial sample size",
  "type": "preprint",
  "updated_at": "2026-10-30T12:17:54Z",
  "url": "https://research.draconitic.com/paper/e0t97cpcxa0dw",
  "venue": "medRxiv",
  "versions": []
}