Tele-Trials: Decentralized Patient-Centered Clinical Trials

This chapter explores the implementation and impact of decentralized clinical trials (DCTs) in Denmark, focusing on their potential to enhance patient-centered care, improve accessibility, and reduce logistical burdens. It also examines the regulatory, technological, and practical challenges associated with DCTs. The chapter employs a comprehensive review of literature, regulatory guidelines, and case studies. It analyzes the historical development of clinical trials, the regulatory framework supporting DCTs, and the current technological landscape. Key elements of DCTs, such as decentralized recruitment, electronic-informed consent, and remote monitoring, are examined through stakeholder perspectives and national and international literature. The findings indicate that DCTs offer significant benefits, including reduced patient burden, improved equity and accessibility, and enhanced data collection. However, challenges such as patient safety, data security, data transfer, quality assurance, and the need for flexible study designs persist. The lack of in-person interaction and potential demographic inequalities are also notable concerns. Despite these challenges, DCTs align with the Quintuple Aim of improved patient experience, better outcomes, lower costs, clinician well-being, and health equity. DCTs can transform clinical trials by making them more patient-centered and accessible. While significant challenges remain, including regulatory, technological, and practical barriers, the overall impact on healthcare efficiency and equity is promising. Future efforts should focus on conducting pilot studies, involving regulators early, and engaging patients to optimize DCT implementation and outcomes.