OBJECTIVES: Alongside the increased use of electronic patient-reported outcomes (ePROs) in trials, the modalities utilized by ePROs have become progressively more varied. Wearable technology has seen rapid consumer adoption and has started to be used in the collection of health data. The aim of this research is to evaluate the use of wearables in clinical outcome assessment (COA) studies.

METHODS: A literature search on Pubmed was completed to understand the current use and benefits/drawbacks of using wearable technology to collect COA data. Different combinations of key search words yielded 32 results out of which 8 articles were selected for study.

RESULTS: Early application of the use of wearable technology demonstrates benefits including: 1) Real-world continuous uninterrupted measurement of health status, 2) Time-marked data, and 3) Improvement in patient compliance. There are several challenges to the adoption of wearable technologies for clinical outcome assessment collection: 1) Data security and privacy, 2) Regulatory acceptance, 3) Inaccurate measurements and 4) Higher costs. One study found that sleep and activity monitors sometimes provided inaccurate or inconsistent data compared to tests done in a clinical setting. Neither the United States FDA nor the EMA have provided any guidance on the acceptability of wearable technology use for clinical trials in which the PRO data are to be used for a label claim pursuit.

CONCLUSIONS: To date, there is only preliminary information published on the utility of wearables for collecting health data. The benefits associated with the wearables may not outweigh the problems and potential cost at this time. Ideally, comparisons with other ePRO modalities would be useful as a baseline. With increasing regulatory input, algorithms improved and standardized, security concerns addressed and costs brought down, this technology may become increasingly useful in the future.