Adapting to Decentralised Clinical Trials: Analysis of Trial Clinician's Experiences and Impacts on the Patient-Centred Experience (Preprint)

BACKGROUND Industry, academic experts, and governing bodies emphasise the importance of prioritising the patient-centred experience in clinical trials to enhance retention, adherence, and trial participation. Concurrently, there has been a notable rise in the adoption of technology-mediated decentralised trial methodologies for conducting clinical trials. OBJECTIVE Our study aims to understand clinicians' perceptions of this transition and its impact on delivering a patient-centred experience. METHODS Fifteen clinicians with experience in facilitating decentralised trials (DCT) were interviewed and transcripts were analysed through reflexive thematic analysis 1. RESULTS Our findings reveal one superordinate theme: the quality and frequency of interactions with patients and clinicians are limited, and six main themes (1) increased clinician demands, (2) the difficulties created for patients, (3) challenges knowing the patient and understanding their experiences, (4) impacts on forming and maintaining clinician-patient relationships, (5) difficulty in delivering desired support and care, and (6) effects on trial conduct. While DCTs offer advantages in improving accessibility, they introduce new complexities that can negatively impact patient engagement, retention, and the clinician-patient relationship. Implications for clinicians include taking on increased technical support roles, adapting to evolving working conditions, and reimagining their responsibilities, necessitating enhanced training programs. Implications for technology design include shifting the focus from solely data collection to creating patient-centred experiences and conditions, employing user-centred design principles and fostering collaboration among stakeholders. CONCLUSIONS One of the primary goals of clinical trials is to collect patient data while navigating several complex challenges, such as regulatory compliance, patient burden, study objectives, safety, scalability, protocols, and ethical considerations. Despite the many benefits of a remote approach, such as improved accessibility and data collection, DCTs have changed the dynamics for patients and clinicians. Approaches that work in traditional face-to-face trials may be less effective in the context of DCTs. As workplaces evolve with increasing technological mediation, clinicians face challenges that inevitably impact their working dynamics and potentially impact overall performance. Clinicians are crucial in navigating DCTs, acting as essential intermediaries between patients, support systems, and trial protocols. To adapt effectively to DCTs and the evolving trial dynamics, clinicians need adequate support and resources. The emphasis on patient technologies in DCT that focus on data collection, understandably vital for clinical trials, and the remote, reduced frequency and types of clinician-patient interactions to minimise patient burden, introduce new expectations and repercussions that impact the overall patient trial experience. Relying on clinicians to support the patient experience without adequately understanding each patient's unique experiences undermines their abilities to fulfil this role. Despite DCTs being presented as a patient-centred approach to trials, our research suggests that significant progress is still needed to realise this vision fully. While DCTs and the technology solutions employed show promise, they often fall short of adequately supporting important components of a patient-centred trial experience, potentially even detracting from it. A patient-centred experience requires a perspective that extends beyond convenience and reduced travel; it involves a complex interplay of personal, emotional, health, environmental, cultural, design, and contextual factors. Refocusing DCTs and how technology enhances these trials is necessary to support patients' diverse needs, recognising them as individuals with unique, personalised requirements backed with clear evidence of benefits. Prioritising conditions and technology that enhance the patient experience in DCTs while maintaining rigorous data collection standards can create a more balanced and effective approach to DCT, ultimately benefiting both patients and clinicians.