Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson’s Disease

Sensors

Anthony Bannon¹  Josh Cosman¹  Katherine Fisher²  George Roussos³  Diane Stephenson⁴  Sakshi Sardar⁴  Martijn L. T. M. Müller⁴  Roopal Bhatnagar⁴  E. Ray Dorsey⁵  Jamie L. Adams⁵  Viktorija Terebaite⁶  Susan J. Lee⁷  Derek L. Hill⁸  Reham Badawy⁹  Tairmae Kangarloo^1,10  Jordan Brayanov^1,10  Kasper Claes^1,11 

[1] AbbVie, North Chicago, IL 60064, USA;Biogen, Cambridge, MA 02142, USA;Birkbeck College,University of London, London WC1E 7HX, UK;Critical Path Institute, Tucson, AZ 85718, USA;Department of Neurology, University of Rochester, Rochester, NY 14642, USA;H.Lundbeck A/S, 2500 Valby, Denmark;Merck, Kenilworth, NJ 07033, USA;Panoramic Digital Health, 38000 Grenoble, France;School of Computer Science, University of Birmingham, Birmingham B15 2TT, UK;Takeda Development Center Americas, Inc., Deerfield, IL 60015, USA;UCB Pharma, 1070 Brussels, Belgium;

关键词: digital health technology;    Parkinson’s disease;    metadata standards;   

DOI  :  10.3390/s22062136

来源: DOAJ

【 摘 要 】

Sensor data from digital health technologies (DHTs) used in clinical trials provides a valuable source of information, because of the possibility to combine datasets from different studies, to combine it with other data types, and to reuse it multiple times for various purposes. To date, there exist no standards for capturing or storing DHT biosensor data applicable across modalities and disease areas, and which can also capture the clinical trial and environment-specific aspects, so-called metadata. In this perspectives paper, we propose a metadata framework that divides the DHT metadata into metadata that is independent of the therapeutic area or clinical trial design (concept of interest and context of use), and metadata that is dependent on these factors. We demonstrate how this framework can be applied to data collected with different types of DHTs deployed in the WATCH-PD clinical study of Parkinson’s disease. This framework provides a means to pre-specify and therefore standardize aspects of the use of DHTs, promoting comparability of DHTs across future studies.

【 授权许可】

Unknown