Data On The Go: Mobile Application Considerations For Clinical Trials And Beyond

With global smartphone subscriptions expected to exceed 7.3 billion by 2025, the utilization of apps for participant engagement and data collection in research has gained substantial traction. The COVID-19 pandemic has further hastened the adoption and demand for research apps that enable remote data collection. Given this context, what factors should be taken into account when selecting or implementing an app for research involving human subjects?

When considering the integration of an app into research, it becomes imperative to comprehensively understand its role within the research process, the legal dimensions associated with its utilization, and the implications for participants, sponsors, and institutional review boards (IRBs) in relation to incorporating mobile applications into research endeavors.

This white paper delves into fundamental definitions, navigates through the regulatory landscape, and examines common applications of apps in research. Moreover, it offers insights into the evaluation of apps by research teams and IRBs, and delves into participant considerations, particularly the safeguarding of user privacy and confidentiality.