A team of researchers from Fraunhofer Portugal AICOS and NOVA Medical School (CHRC) is conducting a review of the literature on the methods for clinical validation of digital endpoints. The results of this work should help guide researchers in choosing validation methods, identify potential gaps in the literature, and inform the development of novel methods to optimise the clinical validation of digital endpoints.

The need for such work has become apparent as researchers mapped the steps from developing digital endpoints to regulatory approval for its use in clinical trials and care. Clinical validation plays an important role, as the evidence generated through clinical validation is mandatory in applications to regulatory authorities for approval. The lack of clearly defined standards and validation methods is a significant challenge preventing the use of digital endpoints.

The protocol for the scoping review has been published in JMIR Research Protocols, and at the moment, half of the titles and abstracts are nearly screened for inclusion in the scoping review. This yet another contribution of COTIDIANA to improve the research and impact of digital endpoints in the digital health solutions.