FDA Issues Draft Guidance on Implementing Decentralized Clinical Trials

May 2, 2023—The FDA announced additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

The agency released a new draft guidance that provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant’s home using telemedicine.

According to the FDA, decentralizing clinical trials will allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, instead of having them visit research sites.

By reducing barriers to participation, the FDA stated, it expects 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 anticipates that this approach will facilitate the development of drugs including in areas of medical need, resulting in more treatment options and improved patient outcomes.

The draft guidance builds on agency recommendations, which were first issued in April 2020, that provided clarity for investigators to facilitate trial decentralization in response to the COVID-19 public health emergency and associated disruptions such as quarantines, site closures, and travel limitations.

FDA Commissioner Robert M. Califf, MD, commented in the agency’s press release, “The FDA has long considered the benefits of decentralized clinical trials. 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, decentralized clinical trials 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 FDA advised that its regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials. The new draft guidance covers recommendations on topics such as the following:

• Design considerations for a DCT
• Conduct of remote clinical trial visits and clinical trial–related activities in a DCT
• Use of digital health technologies to remotely acquire data in a DCT
• Roles and responsibilities of the sponsor and investigators in a DCT
• Obtaining informed consent and institutional review board oversight of the informed consent 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 trial participants in a DCT

The FDA expects that clinical trials with decentralized elements will play an important role in addressing public health needs. The FDA is committed to working with sponsors to discuss how decentralized elements may fit into a clinical trial, noted the agency’s press release.

Comments and suggestions regarding this draft document should be submitted within 90 days of the May 3 publication in the Federal Register of the notice announcing the availability of the draft guidance.