Feasibility of Mobile Technologies in Clinical Research

Mapping 275 Studies on Mobile Technology Feasibility in Clinical Trials

As smartphone applications, wearables, ingestibles, and implantables become increasingly common tools for capturing clinical trial endpoints, sponsors face a practical challenge: with so many mobile technologies available, how do you know which one is actually suited to your study? A systematic scoping review published in npj Digital Medicine, conducted on behalf of the Clinical Trials Transformation Initiative (CTTI), set out to answer exactly that.

Inside the Review

Scope of the review: A systematic search identified 275 publications meeting inclusion criteria, spanning feasibility studies that addressed mobile technology sensor performance, algorithm development, software performance, and operational feasibility.
Structured data extraction: From each study, the authors extracted the medical condition studied, the concept of interest captured by the mobile technology, the outcomes measured, and detailed information on the sensors, algorithms, and study samples used.
A practical decision-support resource: The result is a freely accessible, online database intended to help researchers, ethicists, regulators, and patient groups compare mobile technologies and select the ones best suited to a given study’s endpoints.
A foundation for future linkage: The authors note that, while beyond the scope of this review, a future registry could link studies and trials that adopt the same technology, including tracking successful use of mobile technologies in drug approvals and clinical practice.

Why This Matters for Trial Design

This review underscores a principle central to digital biomarker strategy: selecting a mobile technology for a clinical trial should be an evidence-based decision, not a default one. With hundreds of feasibility studies now cataloged across sensor types, conditions, and outcomes, sponsors have a growing evidence base to draw on when deciding which mobile technology and which validated endpoint fit their specific trial design.

This is the same evidence-first approach Koneksa Health applies when helping sponsors select and validate digital measures: matching the right sensor and algorithm to the right context of use, grounded in the published feasibility literature.

Reference: Bakker JP, Goldsack JC, Clarke M, et al. A systematic review of feasibility studies promoting the use of mobile technologies in clinical research. NPJ Digit Med. 2019;2:47. doi:10.1038/s41746-019-0125-x. PMID: 31304393.