As part of its ongoing effort to advance medical product development and research, the U.S. Food and Drug Administration (FDA) is taking additional steps to support decentralized clinical trials (DCTs) for drugs, biologics, and devices. The agency has released a new draft guidance with recommendations for sponsors, investigators, and other stakeholders regarding the implementation of DCTs. Decentralizing clinical trials allows some or all trial-related activities to occur at trial participants’ homes or other convenient locations, thereby reducing barriers to participation, increasing the breadth and diversity of participants, and improving accessibility for those with rare diseases or mobility challenges.
The FDA expects that this approach will allow for easier development of drugs to improve treatment options and outcomes. Moreover, this draft guidance builds on agency recommendations issued in 2020 in response to the COVID-19 quarantines, site closures, travel limitations, and more.
Although the FDA’s regulatory requirements for medical product investigations are the same for DCTs and traditional clinical trials, the new draft guidance provides recommendations on topics such as design considerations, conducting remote clinical trial visits and clinical trial-related activities, using digital health technologies to acquire data remotely, the responsibilities of the sponsor and investigators, obtaining informed consent, determining the appropriateness of investigational products for use, packaging and shipping of investigational products, and safety monitoring of trial participants.
FDA Commissioner Robert M. Califf, M.D., highlighted the benefits of DCTs, stating that they:
- Enhance convenience for trial participants
- Reduce the burden on caregivers
- Expand access to more diverse populations
- Improve trial efficiencies
- Facilitate research on rare diseases and diseases affecting those with limited mobility.
See the official FDA news release for more information.
