This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine.
The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects ‘will play an important role in addressing public health needs’.
‘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.
