Regulatory Considerations in Technology for Decentralised Clinical Trials – Navigating evolving regu
Decentralised clinical trials (DCTs) are not new, though their popularity and utilisation has grown since the COVID-19 pandemic. DCTs are enabled by and mutually reinforce an expanding innovative “digiverse” that includes all digital technologies that can be customised to support biomedicine and clinical research. This digiverse is changing and expanding rapidly, and regulators have been working to maximise the benefits. The use of digital health technologies (DHTs) has implications for a number of key areas, and regulators have already provided guidance for diversity and inclusion in clinical trials, privacy considerations and endpoint selection, among others.