Digital Solutions Observed in Clinical Trials: A Formative Feasibility Scoping Review.

Growing digital access accelerates digital transformation of clinical trials where digital solutions (DSs) are increasingly and widely leveraged for improving trial efficiency, effectiveness, and accessibility. Many factors impact DS success including technology barriers, privacy concerns, or user engagement activities. It is unclear how those factors are considered or reported in the literature. Here, we perform a formative feasibility scoping review to identify gaps impacting DS quality and reproducibility in trials. Articles containing digital terms published in English from 2009 to 2022 were collected (n=4,167). 130 articles published between 2016 and 2022 were randomly selected for full-text review. Eligible articles (n=100) were sorted into four identified categories: 16% Education, 59% Intervention, 8% Patient, 17% Treatment. Initial findings about DS trends and reporting practices inform protocol development for a large-scale study urging the generation of fundamental knowledge on reporting standardization, best practice guidelines, and evaluation methodologies related to DS for clinical trials.