FDA takes measures to advance decentralized clinical trials with new draft guidance

The FDA has released a new draft guidance offering advice to sponsors and researchers who wish to employ decentralized clinical trials for gathering evidence on the safety and efficacy of drugs, biologics and devices. 

Continuing its issuance of draft guidance documents over the past few months, the US Food and Drug Administration (FDA) has added to its armamentarium with the publication of a draft guidance on the use of decentralized clinical trials (DCTs). Defined by the FDA as ‘a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites’, DCTs are gaining popularity in allowing greater patient accessibility and convenience, reduced costs and administrative burdens, and a means to accelerate the drug development process. New advances in telehealth and digital health technologies (DHTs), where more broader types of trial-related data can be obtained, also make DCTs a more feasible option for some sponsors. The new guidance from the FDA reflects the agency’s new thinking towards ‘reducing barriers to participation…. [to] increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges’.

DCTs can be fully decentralized, where all activities take place at locations other than traditional trial sites, such as the homes of trial participants or in local health care facilities, or hybrid and contain decentralized elements, such as obtaining laboratory tests at a local facility rather than a research medical center. For all DCTs, the regulatory requirements mandated by the FDA for the investigation of medical products is the same as traditional site-based clinical trials.

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The new guidance comes after the agency’s previous recommendations issued in 2020 in response to the need to adapt clinical trials during the COVID-19 pandemic.

“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,” commented Robert M. Califf, M.D, FDA Commissioner. “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 guidance provides advice on nine specific topics relative to DCTs including:

1. Planning and design of DCTs
2. Conducting remote clinical trial visits and DCT-related activities
3. Using DHTs to acquire data remotely
4. Determining roles and responsibilities of sponsors and investigators
5. Obtaining informed consent (IC) and institutional review board oversight
6. Selecting the appropriate use or administration of an investigational drug, biologic or device in DCTs
7. Packaging and shipping of investigational products in DCTs
8. Implementing appropriate safety monitoring plans in DCTs
9. Choosing the appropriate software used in conducting DCTs

When finalized, the guidance will represent the FDA’s current thinking on DCTs.