How do communication, trust and professional relationships shape decentralised clinical trials? A qualitative interview study of international stakeholders

TY - JOUR

T1 - How do communication, trust and professional relationships shape decentralised clinical trials?

T2 - A qualitative interview study of international stakeholders

AU - Coyle, Joanne

AU - Rogers, Amy

AU - Copland, Rachel

AU - Mackenzie, Isla

N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.

PY - 2026/8/7

Y1 - 2026/8/7

N2 - OBJECTIVES: 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). DESIGN: Qualitative interview study using semi-structured interviews and thematic analysis. SETTING: International decentralised and hybrid clinical trials conducted across multiple therapeutic areas and healthcare contexts. PARTICIPANTS: Thirty-one stakeholders involved in the design and delivery of DCTs, including investigators, trial managers, administrators, industry personnel and service vendors. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.N/A.

AB - OBJECTIVES: 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). DESIGN: Qualitative interview study using semi-structured interviews and thematic analysis. SETTING: International decentralised and hybrid clinical trials conducted across multiple therapeutic areas and healthcare contexts. PARTICIPANTS: Thirty-one stakeholders involved in the design and delivery of DCTs, including investigators, trial managers, administrators, industry personnel and service vendors. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.N/A.

KW - Decentralised clinical trials

KW - clinical trial delivery

KW - qualitative research

KW - communication

KW - trust

KW - trial oversight

KW - health research implementation

KW - digital health

KW - Health Services

KW - Clinical Trial

KW - Patient-Centered Care

KW - QUALITATIVE RESEARCH

KW - Telemedicine

KW - Digital Technology

UR - https://www.scopus.com/pages/publications/105046715197

U2 - 10.1136/bmjopen-2026-118118

DO - 10.1136/bmjopen-2026-118118

M3 - Article

C2 - 42567640

SN - 2044-6055

VL - 16

SP - e118118

JO - BMJ Open

JF - BMJ Open

IS - 8

M1 - e118118

ER -