JMIR Publications

ABSTRACT

Background:

Decentralized clinical trials (DCTs) are becoming more popular in the clinical trials industry and researchers are frequently seeking new strategies to optimize and enhance the decentralized approach. Online digital platforms offer trial teams and participants tools to support trial activities and streamline trial processes, but there are important considerations to be addressed when selecting a platform.

Objective:

This narrative review aims to illustrate how digital platforms can support DCT conduct but will also highlight key areas where platform use may be restrictive or inappropriate. We will also discuss technical challenges surrounding platform adoption.

Methods:

We scanned available literature for digital platform use in decentralized trials and integrated our findings with academic and experiential expertise on DCT methodology and technologies.

Results:

Several DCTs have reported using digital platforms or individual platform modules in their trials. These have been used as tools to support trial staff and participants but were associated with potential drawbacks. Digital platforms can support DCT strategies for remote data collection, increased remote trial accountability, and overall greater data integrity. Platforms may also foster participant engagement through gamification, customization, and pop-up reminders. Trial participants can also use digital platforms for remote outcome reporting and completing trial visits remotely. Despite these advantages, platforms are limited both in service provision and in population-specific suitability. Lack of digital literacy, difficulties sustaining platform engagement, resource availability, inappropriate platform design, and concerns around security and governance may hinder the success of digital platforms in DCTs. Unified and fully-integrated platforms may address issues with limited service provisions but insufficient or inappropriate architecture, lack of interoperability, and unclear data standardization protocols may also restrict platform success.

Conclusions:

Digital platforms have been widely used as tools to provide support in decentralized trial activities throughout the DCT lifecycle and demonstrate benefits for both trial staff and participants, but further research is needed to address challenges in platform suitability and uptake.