FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability

The US Food and Drug Administration’s (FDA) final guidance on decentralized clinical trials (DCTs) addresses some key issues from the draft guidance raised by clinical experts and industry groups, including providing more information on requirements to keep a task log of healthcare providers (HCPs), physical inspection requirements, and clarifying challenges around data variability in DCTs.

The agency defines DCTs as occurring at non-traditional clinical trial locations, such as a participant’s home or in a local healthcare facility. These local providers and clinical laboratory facilities may be used in a trial with decentralized elements to manage trial participants, and use digital health technologies and telehealth to obtain data. FDA noted that trials with decentralized are subject to the same regulatory requirements as those with non-decentralized elements.

“By allowing remote participation and reducing the need to travel for face-to-face visits, DCTs may enhance convenience for study participants, facilitate research on diseases affecting populations with limited mobility, and reduce the burden on caregivers,” FDA wrote in a Federal Register notice accompanying the final guidance.

The final guidance provides recommendations for using decentralized components in clinical trials. This includes elements like such as use of decentralized health technologies and software, roles and responsibilities for sponsors and investigators, using local healthcare providers as well as remote clinical trial visits, and trial design, conduct, and oversight. The final guidance also outlines informed consent and institutional review board oversight, what investigational products can use a DCT, how to package and ship investigational products, and patient safety processes and procedures.

At the Drug Information Association Global Annual Meeting in 2023, clinical trial experts were supportive of the draft guidance overall, but raised issues with the reporting requirements outlined in the guidance. They noted a lack of clarity in the reporting requirements could create uncertainty, and cited Form FDA 1572 as a potential problem for decentralized trials when determining what research locations would need to be stated on the form. (RELATED: FDA issues draft guidance on decentralized clinical trials, Regulatory Focus 2 May 2023;
DIA: Experts call for more clarity on reporting requirements in FDA’s DCT guidance, Regulatory Focus 30 June 2023)

In comments responding to the draft guidance, industry groups were also largely positive, but stakeholders asked for a broader definition of DCTs, wanted more clarification on how DCTs appeared to be held to a higher standard in the draft guidance than for centralized trials, and made requests to FDA for more virtual inspections in DCTs. (RELATED: Industry groups call for better alignment between decentralized, centralized trials, Regulatory Focus 4 August 2023)

Changes from draft guidance

Large portions of the final guidance have been rewritten, and FDA said they made editorial changes in the final guidance to improve clarity. In addressing comments raised in response to the draft guidance, FDA removed all mentions of a requirement to create and maintain a local task log of HCPs contracted for trial-related services in routine clinical practice.

FDA also provided more specific examples surrounding the challenges of data variability in DCTs. They noted the trial design should limit variability from trial-related activities performed by HCPs and trial personnel as well as activities that can performed by participants at home, such as spirometry tests. To reduce the potential for data variability, stakeholders should consider training and video supervision in the case of participant activities performed independently, and to specify what activities are permitted remotely, at trial sites, or can be based on participants’ preference.

The agency also updated its responsibilities for sponsors in DCTs that use local HCPs, noting that networks of local HCPs can be used for contracted services. “Sponsors should ensure these networks of local HCPs are qualified to perform the contracted activities,” FDA said. “Sponsors should also keep a record of these networks and other contracted service providers, including their roles and assigned activities.”

Concerning physical inspections for DCTs, FDA clarified that there needs to be a physical location where FDA inspectors can access records related to the trial, whether paper records or electronic access for “participants under the clinical investigator’s care” and to coordinate remote or in-person interviews with trial personnel. This physical location is usually the inspection location for clinical investigators in section 1 and section 3 of Form 1572 in the case of an investigational new drug, or included in an investigational device exemption, but can be another location, FDA said.

Final guidance

FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability

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