On May 2, 2023, the U.S. Food and Drug Administration have released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of Decentralized Clinical Trials (DCTs) to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, FDA 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. FDA 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This draft guidance builds on FDA’s recommendations issued in 2020, which provided clarity for investigators to facilitate trial decentralization in response to the COVID-19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.
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for investigations of medical products are the same for DCTs and traditional site-based clinical trials, the new draft guidance covers recommendations on topics such as: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.
