May 02, 2023: “The U.S. FDA is taking 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The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development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.
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, 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.
We anticipate that this approach will facilitate the development of drugs including in areas of medical need, resulting in more treatment options and improved patient outcomes.
This draft guidance builds on agency recommendations issued in 2020, which provided clarity for investigators to facilitate trial decentralization in response to the COVID-19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.
“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,” said FDA Commissioner Robert M. Califf, M.D.
“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.”
While the FDA’s 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for investigations of medical products are the same for DCTs and traditional site-based clinical trials, the new draft guidance covers recommendations on topics such as:
- 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 (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; and
- 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.