FDA releases draft guidance for decentralised clinical trials

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices.

The publication includes recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.

In DCTs, some or all the clinical trial-related activities occur at locations other than traditional clinical trial sites. Examples of these activities include obtaining laboratory tests at a local facility rather than a research medical centre or conducting a clinical follow-up visit in the trial participant’s home using telemedicine.

By reducing barriers to participation, the FDA anticipates that DCTs will increase the range and diversity of clinical trial participants and improve accessibility for those with rare diseases or mobility challenges. Ultimately, the regulatory body hopes the approach will result in more treatment options and improved patient outcomes.

FDA recommendations for delivering decentralised clinical trials

According to the FDA, the new draft guidance for DCTs covers recommendations on topics including: 

• DCT design considerations
• Conduct of remote clinical trial visits and DCT clinical trial-related activities
• Use of digital health technologies to remotely acquire data
• Roles and responsibilities of the sponsor and investigators in a DCT
• Obtaining informed consent (IC) and institutional review board oversight of the IC process in a DCT
• Determination of the appropriateness of investigational products for use in a DCT
• Packaging and shipping of investigational products in a DCT
• Safety monitoring of DCT participants.

This draft guidance builds on recommendations published by the agency in 2020. These earlier recommendations provided clarity for investigators to facilitate trial decentralisation in response to the COVID-19 pandemic, helping to overcome barriers as quarantines, site closures and travel limitations.

“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,” explained FDA Commissioner Dr Robert M Califf.

The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.