FDA Publishes Draft Guidance for Decentralized Clinical Trials

Yesterday, the FDA published a copy of its draft guidance for decentralized clinical trials, adding to previously issued guidelines. Clinical trial participants may be able to bring trials to their homes or communities, reducing the time and resources needed to journey to an academic or research center.

According to the press release, the FDA published recommendations in March 2020 on conducting clinical trials while maintaining social distancing and good public health practices during the height of the pandemic. That recommendation included guidelines on how to facilitate clinical trials using decentralized tools.

“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, MD, in the press release.

Since the pandemic, decentralized clinical trials have gained popularity, as they can elevate the clinical trial landscape. In addition to expanding the reach of clinical trials, decentralized protocols may improve participant enrollment and retention.

To clarify the appropriate use of decentralized clinical trials, the FDA has issued new draft recommendations. While the protocols have not been finalized, once they are, the FDA will point to these recommendations for best practices in decentralized clinical trials.

The recommendations touch on the following topics:

• Decentralized clinical trial designs
• Remote clinical trial visits
• Digital health technologies
• Roles and responsibilities for sponsors and investigators
• Informed consent
• Investigational products in decentralized clinical trials
• Packing and shipping investigational products
• Safety monitoring
• Software use

Beyond convenience, decentralized clinical trials may help facilitate clinical trial diversity by recruiting a broader range of patients, varying in backgrounds, through collaboration with community partners.

“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,” added Califf.