How do communication, trust and professional relationships shape decentralised clinical trials? A qualitative...

To investigate the impact of decentralisation on communication, trust and professional relationships in the context of clinical trials and to identify practical strategies to support coordination and oversight in decentralised clinical trials (DCTs).

Qualitative interview study using semi-structured interviews and thematic analysis.

International decentralised and hybrid clinical trials conducted across multiple therapeutic areas and healthcare contexts.

Thirty-one stakeholders involved in the design and delivery of DCTs, including investigators, trial managers, administrators, industry personnel and service vendors.

Participants were purposively sampled from a series of DCT case studies. Semi-structured interviews were conducted via videoconferencing, audio-recorded and transcribed verbatim. Data were analysed using a thematic framework approach to identify themes relevant to communication, coordination and trial oversight. Reporting followed the Standards for Reporting Qualitative Research guidelines.

Three interrelated themes were identified. First, DCTs operate as complex networks of formal and informal connections through which information, responsibilities and decisions flow. Second, effective communication and trust-building were viewed as central to participant safety, protocol adherence and collaboration, but were more difficult to establish in remote trial contexts. Third, unclear roles and responsibilities contributed to communication delays, coordination challenges and increased operational risk. Participants highlighted the value of proactively clarifying responsibilities and communication pathways during trial set-up and delivery. A social network perspective was identified as a useful heuristic tool for understanding these dynamics.

DCTs place increased demands on communication, coordination and relationship-building across distributed teams. Proactively clarifying roles, responsibilities and communication pathways may support more effective trial delivery and oversight. Although focused on DCTs, these findings are relevant to other digitally mediated and multi-stakeholder models of health research delivery.

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