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Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations

Authors
  • Crouthamel, Michelle
  • Mather, Robert J.
  • Ramachandran, Suraj
  • Bode, Kai
  • Chatterjee, Godhuli
  • Garcia-Gancedo, Luis
  • Kim, Joseph
  • Alaj, Rinol
  • Wipperman, Matthew F.
  • Leyens, Lada
  • Sillen, Henrik
  • Murphy, Tina
  • Benecky, Michael
  • Maggio, Brandon
  • Switzer, Thomas
Type
Published Article
Journal
Digital Biomarkers
Publisher
S. Karger AG
Publication Date
Sep 02, 2021
Volume
5
Issue
3
Pages
191–205
Identifiers
DOI: 10.1159/000518024
PMID: 34703974
PMCID: PMC8460981
Source
Karger
Keywords
Disciplines
  • Research Reports - Research Article
License
Green
External links

Abstract

The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). RA patients often suffer joint pain, fatigue, and sleep disturbances (SDs). Although many researchers have investigated the mobility of joint functions using wearable technologies, the research of SD in RA has been limited due to the availability of suitable technologies. We proposed measuring the improvement of sleep as the novel endpoint for an anti-TNF therapy and described the meaningfulness of the measure, considerations of tool selection, and the design of clinical validation. The recommendations from the FDA patient-focused drug development guidance, the Clinical Trials Transformation Initiative (CTTI) pathway for developing novel endpoints from DHTs, and the V3 framework developed by the Digital Medicine Society (DiMe) have been incorporated in the proposal. Regulatory strategy and engagement pathways are also discussed.

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