The U.S. Food and Drug Administration (FDA) released draft guidance on decentralized clinical trials (DCTs) on May 2, 2023, as promised by the FDA Reauthorization Act (FDORA). This guidance aims to “support the use of DCTs in drug, biologic, and device trials, where some or all trial-related activities occur outside of traditional clinical trial sites.”1
While the FDA’s regulatory requirements remain the same for both DCTs and traditional site-based studies, the unique nature of DCTs necessitates specific guidelines. As such, this new draft guidance covers a wide range of recommendations, including:
- How to determine if DCT design is appropriate for an investigational product (IP)
- Design considerations
- How to conduct remote trial visits and trial-related activities
- The role digital health technology (DHT) plays in remotely capturing data
- Sponsor and investigator responsibilities
- How to navigate informed consent and institutional review board oversight
- Maintaining patient safety
- IP packaging and shipping
But what are the most important takeaways from the draft guidance? And what do you need to do about them right now?
This is part one of a two-part series in which we will review seven essential takeaways from this new guidance. Let’s dive in.
1) Decentralized and Digital Clinical Trial Definitions
FDORA defined DCTs as “clinical trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.”2 The new draft guidance provides further clarity on what distinguishes DCTs from site-based trials, mainly the utilization of remote trial personnel, local healthcare providers (HCPs), telehealth, and DHT to facilitate trial-related activities.3
One significant aspect of the draft guidance is the formalization of fully decentralized trials and hybrid trials. While these terms have informally been used in the industry for years, the FDA’s guidance now provides sanctioned definitions.
A fully decentralized trial refers to a trial where all activities take place at locations other than traditional trial sites, such as the homes of trial participants or local healthcare facilities. The FDA notes that fully decentralized trials are not suited for all studies, but only for those involving IPs that are “simple to administer or use, have well-characterized safety profiles, and do not require complex medical assessments.”3
On the other hand, hybrid trials involve a combination of in-person visits by trial participants to traditional, central sites and study activities conducted at other locations. The draft guidance specifies that, just like full DCTs, hybrid trials are not ideal for all studies. They are only to be used in trials where “the administration of an IP or a complex medical assessment needs to be performed at a clinical trial site and some follow-up assessments could be performed remotely through online patient-reported outcome measures, via telehealth or in-home visits, or by local HCPs.”3
These clear definitions provided by the FDA’s draft guidance lay the groundwork for a more patient-centric industry, as they will help researchers determine the most suitable and accessible approach for their specific trial.
2) Contracting Local Physicians to Boost Patient Centricity
According to the guidance, trial-related activities that require in-person visits can be carried out by HCPs in a patient’s community. However, these HCPs do not have to be designated trial personnel but can instead be contracted on a fee-for-service basis by sponsors or principal investigators (PIs).3
It is important to note that the services provided by these HCPs should not require detailed knowledge of the trial protocol or the IP and should not differ from the HCP’s standard scope of practice, such as physical exams or interpreting medical scans. Certain trial-related activities that are unique to the research or require a detailed understanding of the trial protocol or IP should only be performed by, per the guidance, “qualified trial personnel who have received appropriate training.”3 These activities may include specialized procedures or assessments that necessitate specific expertise or knowledge beyond standard clinical practice.
3) Form FDA 1572 and the Task Log
One area of DCTs that has sparked considerable debate is how best to complete Form FDA 1572, which is based on brick-and-mortar research sites. Recognizing the need for clarity, the FDA has addressed this complex issue in its new draft guidance. It states that for inspection purposes, DCTs should identify one physical location where all clinical trial-related records for participants under the investigator’s care are accessible and where trial personnel can be interviewed. This location must be explicitly listed on Form 1572 or, in the case of investigational device exemption (IDE), on the IDE application.3 This interpretation implies the use of a single Form 1572 across all trial locations, with one designated PI.
When it comes to identifying DCT sub-investigators, the FDA maintains consistency with previous guidance regarding the completion of Form 1572. According to this guidance, individuals who directly contribute to the trial data in a significant manner should be identified as sub-investigators. Therefore, local HCPs who perform routine trial-related services that do not require detailed knowledge of the IP and protocol should not be listed as sub-investigators on Form 1572.3
To address the inclusion of local HCPs in study records and maintain study oversight, the draft guidance introduces a new document called the task log. While similar in nature to a study Delegation of Authority (DOA) log, a task log is intended to capture only those local HCPs who perform trial-related activities, and not delegated study staff. The task log is a record that should include the HCP’s:
- Name and affiliation
- Role in the trial
- Trial tasks
- Completion dates and locations of trial tasks
The investigator must also sign and date the task log when it’s first created and whenever a new HCP is added.3
For running trial-related tests, the FDA guidance also states that designated labs are preferred, but local labs are sufficient if they are well-standardized. All labs must be included on Form 1572, but technicians and other clinical lab staff should not be included on the form or the task log.3
Efficiently and Easily Meet DCT Requirements With Elligo Health Research®
Navigating the complexities of DCTs can be challenging, especially with the added layer of new FDA guidance. At Elligo, we understand the intricacies involved and offer solutions that make conducting compliant and efficient DCTs easier than ever before.
For instance, the guidance emphasizes the importance of diversity and inclusiveness in research participants, encouraging outreach through local healthcare institutions, like pharmacies and clinics, to bolster enrollment equity in communities where there are no traditional research centers or sites. Elligo has been utilizing community providers for years to increase access to trial participation, and our well-established processes seamlessly align with these goals. By involving local healthcare providers, we leverage existing infrastructure and overcome cultural or linguistic barriers, enhancing engagement, recruitment, and retention of diverse participants.
There’s also the question of varying state laws in DCTs. Compliance with local laws, regulations, and licensing requirements is vital, and it’s the sponsor’s job to make sure subinvestigator IP administration, telehealth visits, and other hybrid or remote trial conduct meet legal and regulatory obligations for the various states and territories in the U.S. Elligo has already addressed this issue in our published white paper, “Navigating Licensing Laws and Regulations on Decentralized Clinical Trials That Cross State Lines,” in which we directly contacted the FDA for clarity on investigator locations and licensing.
Partner With Elligo for DCT Compliance and Excellence
The newly released FDA guidance on DCTs aligns well with Elligo’s established procedures, giving us confidence in our compliance. The guidance supports our ongoing efforts to enhance technology, promote patient diversity, and enable research as an integral part of healthcare.
Part two of this series will cover takeaways four through seven – don’t miss it! Want to learn more now? Contact our team.
1. FDA Takes Additional Steps to Advance Decentralized Clinical Trials. U.S. Food and Drug Administration. Published 2023 May 2.
2. H. R. 2617. Authenticated U.S. Government Information GPO. Accessed 2023 May 24.
3. Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders. U.S. Food and Drug Administration. Published 2023 May.