Clinical trials are crucial for evidence-based medicine, yet they face increasing challenges due to NHS pressures, the need for broader patient representation, and alignment with current care pathways. Traditionally, trials required participants to visit physical study sites, but Decentralised Clinical Trials (DCTs) aim to reduce or eliminate these visits by delivering trial components locally.
For instance, blood tests can be done at local GPs, questionnaires completed online, and activity monitored via devices like Fitbits.
The COVID-19 pandemic accelerated the adoption of DCTs, highlighting the limitations of traditional methods and prompting regulatory bodies like the FDA and MHRA to support remote and digital approaches. The UK government also emphasized a patient-centric approach in its 2021 vision for clinical trials, recommending innovative methods to streamline processes and reduce NHS strain.
DCTs offer several benefits, such as improved access to trials, particularly for rare diseases, reduced participant burden, and increased inclusivity. By integrating trial activities into daily routines, DCTs can enhance enrollment and retention while improving operational efficiency and cost-effectiveness. They also enable real-time safety monitoring, which can lead to more representative data collection.
However, DCTs present challenges, including ensuring patient safety without regular site visits, managing data security risks associated with digital devices, and addressing ethical issues in remote informed consent. Effective oversight and compliance in a decentralised model require robust systems and clear communication among all parties involved.
Future research will explore the practical and patient-specific aspects of DCTs, focusing on their feasibility and acceptability in cancer trials. This involves engaging with patients, clinicians, and regulatory bodies to understand diverse perspectives and incorporate decentralisation effectively into clinical research.