Building bridges in decentralized clinical trials: A qualitative exploration of stakeholder collaboration and...

Decentralized clinical trials (DCTs) are increasingly recognized by the stakeholders for their potential to enhance flexibility, accessibility, and convenience. However, their widespread implementation continues to encounter challenges. Recognizing the pivotal role of diverse stakeholders in clinical trial success, we aimed to explore stakeholder perspectives on DCT opportunities, challenges, and strategies for effective implementation.

This paper presents the qualitative findings from a broader mixed-methods online survey involving stakeholders with experience in DCTs. A total of 288 individuals from various regions and organizations, including sponsors, contract research organizations (CROs), technology vendors, hospital personnel, and medical research professionals, participated in the survey from 38 countries. A semantic thematic analysis approach following Braun and Clarke's (2006) six-step methodology was employed to interpret the open-ended responses.

Thematic analysis revealed ten major themes encompassing 61 verbatim quotes. Trial design and protocol optimization emerged as the dominant theme, emphasizing context-specific rather than universal DCT approaches. Hybrid DCT models were strongly preferred as practical solutions, balancing innovation with operational feasibility. Patient-centric design and technology adoption highlighted the critical importance of trust-building and addressing digital literacy disparities. Additional themes addressed training needs, operational challenges, regulatory compliance, and stakeholder collaboration.

Successful DCT implementation requires coordinated, patient-centered approaches tailored to specific trial contexts. While DCTs address many barriers of conventional clinical trials, strategic planning emphasizing hybrid models, comprehensive stakeholder training, and cultural adaptation is essential to ensure patient safety, data integrity, and sustainable adoption.