New study highlights challenges of decentralised clinical trials for patients and researchers

24 Jul 2025

• Research highlights how the shift to remote, technology-mediated trials is reshaping how research staff coordinate and deliver trials.
• The study reveals concerns about how remote trials are changing how staff support and engage with patients, raising questions about impact on the overall experience, connection and care.

A new study shows that while decentralised clinical trials (DCTs) are making research more accessible, they also bring challenges for research staff that can increase clinical staff workload, negatively impact the patient experience, and impact trial delivery.

Led by researchers at University College Cork (UCC), the study investigated how remote, tech-enabled clinical trials are affecting the experience of research staff in coordinating and delivering trials, as well as their impressions of how DCTs impact the patient experience. 

The findings are published in the Journal of Medical Internet Research.

The research, based on interviews with clinical research staff, highlights how the move to remote, technology-mediated trials is impacting how they deliver trials. Decentralised clinical trials allow patients to participate in clinical trials from home using digital tools, an approach that can reduce logistical burdens and improve accessibility.

However, the study found that these benefits can come at the expense of the support, care, and researcher-patient relationships. Clinical research staff reported that the remote and technology-driven approach makes it harder to build relationships, establish trust, understand what patients are going through, and provide the level of support they can offer in traditional site-based trials.

Clinical research staff also reported heavier workloads, with roles expanding to include troubleshooting tech issues, patient training, and navigating new platforms, suggesting the need for additional support or training.

While technology enables remote participation and monitoring, patients, especially older adults, struggle with unfamiliar tools, which can lead to burden, stress, confusion, and in some cases, withdrawal from the trial.

These factors collectively can affect patient engagement, accountability, and compliance, potentially undermining the success of the research.

Participants included clinical research staff from several countries, including the USA, Canada, Ireland, and Belgium.

Eoin Gamble, study lead and PhD researcher in UCC School of Applied Psychology, said: “Patient centricity has become a core consideration in clinical trials. Remote trials aim to support this goal, improving accessibility and convenience and in many ways, they do. But they’ve also introduced new challenges. Our study shows that clinical staff’s ability to understand and support patients is affected, and researchers are being stretched, expected to take on multiple roles. At the same time, the remote format and use of technology can create challenges for patients, which may negatively impact their experience, as well as accountability, compliance, engagement, and potentially retention.”

“As trials shift toward remote, technology-mediated approaches, the dynamic of trial participation has changed. We need to consider how both site- and patient-facing technology can evolve to better support research staff, complement the care they provide, and intentionally support the experience for patients,” Eoin Gamble said.

The study calls for better integration of human-centred design and behavioural science approaches in technology, more support and training for clinical staff, and design that considers patients’ varied needs, beyond just their ability to take part in trials from home.