Need for Digital Biomarkers in Musculoskeletal Trials

Abstract

Pain and loss of function - both problems cause patients to visit a musculoskeletal specialist. Therefore, both lead symptoms should serve as a benchmark for new therapeutic approaches. New technologies generating digital biomarkers have the potential to significantly change musculoskeletal trials. However, more work is needed to agree upon data and variable standards, to improve user friendliness, and to ensure data integrity along the whole processing way. Therefore, rigorous and systematic testing of new technological approaches is required to establish new outcome variables suitable for musculoskeletal trials. Consortia of researchers working on similar technologies and outcome variables should collaborate from the beginning to enable comparing and pooling data. Early interaction with health authorities and regulatory bodies are necessary to pave the way for a widespread use of a new technology.

Keywords: Digital biomarker; Musculoskeletal trial.

Fig. 2

Interest of different stakeholders in the WHO International Classification of Functioning, Disability and Health (ICF), modified after: Towards a Common Language for Functioning, Disability and Health. ICF. Geneva, WHO, 2002. QoL, quality of life.

Fig. 1

Difference between self-reported walking and weight training activities and real-world moderate-intensity activity measured with accelerometry in the LIFE study by Pahor et al. [6]; reproduction with permission of Pahor et al.