Mobile devices hold great potential to transform clinical trials by their ability to capture objective, real-world health data directly from study participants. While this technology shows promise to improve the quality and efficiency of medical product development, questions remain on how to successfully integrate mobile devices for data capture into clinical trials.

On June 16, 2017, CTTI convened a multi-stakeholder expert meeting to further refine solutions to the scientific and technological challenges preventing widespread adoption of mobile devices in clinical trials. A meeting summary is now available, including the following:

• The recommended best practices for studies using mobile devices for data capture do not differ significantly from many of the best practices that we already apply to clinical trials.
• Studies using mobile devices for data capture should not be held to higher standards than traditional trials.
• Efforts to leverage mobile devices for data capture should strive to engage patients in study design and endpoint selection.

The MCT Mobile Technologies Project focuses on using mobile devices in FDA-regulated clinical trials after initial participant consent—in other words, the use of devices for data capture rather than for recruitment, retention, or as the study intervention. The project team will use findings from the expert meeting to develop recommendations and tools that guide the adoption of mobile devices for data capture in clinical trials.