27 July, 2025
new-study-uncovers-challenges-of-decentralized-clinical-trials

A recent study conducted by researchers at University College Cork (UCC) has highlighted the complexities associated with decentralized clinical trials (DCTs). While these trials aim to enhance accessibility for patients by allowing participation from home, they also introduce significant challenges for clinical research staff. The findings, published in the Journal of Medical Internet Research, reveal how the shift towards remote, technology-enabled trials impacts both the experience of research staff and the overall patient journey.

The research involved qualitative interviews with clinical research personnel from several countries, including the United States, Canada, Ireland, and Belgium. It underscores that while DCTs can alleviate logistical burdens for patients, they may inadvertently diminish the quality of support and care that research staff can provide.

According to Eoin Gamble, the study lead and Ph.D. researcher at UCC’s School of Applied Psychology, “Patient centricity has become a core consideration in clinical trials.” He noted that these remote trials are designed to improve accessibility and convenience, but they have also introduced new challenges.

Participants in the study reported that the remote format complicates the establishment of relationships and trust between researchers and patients. Clinical staff expressed concerns about their ability to understand patients’ needs fully, which can be crucial for effective support. The demands of managing technology-driven trials have led to an increased workload, as staff must now troubleshoot technical issues, provide patient training, and navigate new digital platforms.

A significant concern raised by the study is the struggle faced by many patients, particularly older adults, with unfamiliar technological tools. This lack of familiarity can lead to feelings of stress and confusion, ultimately resulting in some patients withdrawing from trials. These challenges can negatively influence patient engagement, accountability, and compliance, which are essential for the success of clinical research.

Gamble emphasized the need for a balanced approach as trials increasingly incorporate remote technology. “As trials shift toward remote, technology-mediated approaches, the dynamic of trial participation has changed,” he noted. He called for better integration of human-centered design and behavioral science into technology used in clinical trials, alongside enhanced support and training for clinical staff.

The study advocates for a design philosophy that addresses the diverse needs of patients beyond the mere capability of participating from home. It suggests that trial technology should not only facilitate remote participation but also reinforce the care provided by clinical staff.

The findings from this research highlight the dual nature of decentralized clinical trials. While they enhance accessibility, they also pose significant challenges that must be addressed to ensure a positive experience for both patients and clinical research staff. As the landscape of clinical trials evolves, the insights from this study may inform future developments in trial design and implementation, ensuring that the patient experience remains at the forefront of clinical research.

For more detailed information, refer to the study titled “Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study,” published in the Journal of Medical Internet Research in 2025.