FDA issues new draft guidance on decentralised clinical trials
The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional investigation sites.
‘By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,’ the FDA said in a statement.
The guidance covers recommendations on topics such as DCT design, the use of digital health technologies for remote patient monitoring, and the roles and responsibilities of sponsors and investigators.
