The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional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.
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.
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.
Guidance on determining the appropriateness of investigational products for use in a DCT, packaging and shipping of investigational products, and safety monitoring for trial participants is also included within the document.
The FDA first issued recommendations on DCTs in 2020 in response to the COVID-19 pandemic and associated disruptions such as lockdowns, site closures and travel limitations.
FDA commissioner, Robert Califf, said: “The FDA has long considered the benefits of DCTs. Advancements in digital health technologies and the COVID-19 pandemic – when in-person visits were limited or unavailable for many trial participants – have accelerated the broader adoption of these activities.
“As we seek to improve our evidence generation system, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.”
The recommendations come just over a month since the FDA proposed improvements for oncology clinical trials used to support accelerated approval.
The guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, discusses a potential advantage of randomised clinical trials over single-arm studies.