JMIR Publications

ABSTRACT

Background:

Decentralized clinical trials (DCTs) are transforming traditional research by allowing participants to remotely take part through digital technologies such as telemedicine, mobile applications, and digital platforms, overall enhancing participation, safety, accessibility, and overall trial outcomes. The COVID-19 pandemic further accelerated adoption, as there was a pressing need to minimize infection risks, delays, and disruptions. Despite growing innovation and initiatives like Trials@Home, there is limited understanding of how commercial technologies align with and support trial operations in the DCT lifecycle.

Objective:

This study aimed to map the landscape of commercial technologies used in DCTs and assess their availability, suitability, and alignment with clinical trial operations across the DCT lifecycle.

Methods:

A market scan of commercial technologies was conducted in 2024-2025 to update and add on previous work in 2020 using a structured approach. Seven peer groups were formed, each assigned to one of seven Basic Building Blocks (BBBs) representing key phases of the clinical trial lifecycle. These groups independently reviewed and categorized relevant solutions. The process included reassessment of previously identified solutions and identification of new technologies through keyword-based web searches, and categorization by the number of BBBs covered. Solutions also were categorized as Single- or Multiple-BBB based on their coverage, and a co-occurrence analysis identified strong and underrepresented pairings in BBB coverage.

Results:

The scan identified 312 technological solutions supporting DCTs. A similar distribution of solutions across BBBs was observed, with Set-up and Design and Patient Engagement being the most represented, while Operation and Coordination was the least covered. Most tools were specialized, with 226 single-BBB solutions, 48 covering two BBBs, and fewer than 10 addressing five or more. Only 2 solutions covered all seven BBBs. Co-occurrence analysis revealed strong overlaps between Patient Engagement, Intervention and Follow-up, and Operation and Coordination, while Set-up and Design showed minimal overlap with other BBBs.

Conclusions:

The rapid evolution of DCT technologies highlights the importance of structured assessments to guide technology selection. The balanced distribution of solutions per BBB suggests a broad coverage of trial operations. The stronger coverage in Set-up and Design and Patient Engagement compared with Operation and Coordination indicates areas for further development. The majority of tools were highly specialized with only a few covering multiple trial operations in an integrated manner. This reflects the maturity of specialized solutions and the potential for comprehensive systems spanning the full trial lifecycle. The strong pairs between Patient Engagement with Operation and Coordination and Intervention and Follow-up, together with the minimal overlap of Set-up and Design reveal a gap between planning and execution phases. This study provides a comprehensive catalogue of technologies, and offers practical insights to inform strategic technology selection for more efficient, inclusive, and connected clinical trial operations.