Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations
| Autor: | Brandon Maggio, Tina Murphy, Matthew F. Wipperman, Robert J. Mather, Luis Garcia-Gancedo, Godhuli Chatterjee, Lada Leyens, Michael Benecky, Joseph Kim, Henrik Sillen, Thomas Switzer, Rinol Alaj, Kai Bode, Michelle Crouthamel, Suraj Ramachandran |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Strategic planning
Process (engineering) Computer science business.industry QH301-705.5 Medicine (miscellaneous) Health Informatics novel digital endpoint Digital health Computer Science Applications Clinical trial Research Reports - Research Article Risk analysis (engineering) Drug development Multidisciplinary approach hypothetical study Sleep (system call) Biology (General) business validation framework Wearable technology |
| Zdroj: | Digital Biomarkers, Vol 5, Iss 3, Pp 191-205 (2021) Digit Biomark |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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