By Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare
On May 1, 2023, the FDA released new guidance for decentralized clinical trials (DCTs), clarifying regulatory requirements and helping to pave the way for more widespread adoption of this innovative trial model. Although the guidance has been well-received, it has also raised some new questions and challenges for the industry. In this blog post, we’ll explore the key points of the FDA DCT guidance and discuss their implications for the future of clinical trials.
Defining Decentralized Clinical Trials
The term Decentralized Clinical Trials (DCTs) has been circulating for some time, but industry experts have yet to reach a consensus on its definition. According to the FDA’s recent guidance, DCTs are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites. To successfully implement DCTs, proper training, oversight, and risk assessment are required, similar to traditional on-site trials.
Regulatory Requirements for Decentralized Clinical Trials?
Although the guidance is welcomed by sites and sponsors, it does not completely resolve the issue of oversight and management of third-party vendors. The industry has grappled with the concept of PI oversight in the era of DCTs for some time, particularly with the evolving definition of a “research site” in a DCT model. The recent guidance specifies that the PI continues to be responsible for overseeing study procedures, irrespective of their location.
As per the FDA guidance, the regulatory requirements for DCTs align with those for traditional site-based trials. This indicates that the principal investigator (PI) is still accountable for the oversight of study procedures, no matter where they take place. However, the guidance does not explicitly discuss the challenges posed by home health vendors, which are becoming more common in sponsor engagements and present oversight difficulties for PIs. This concern might lead to changes in the utilization of home health providers in future studies.
Record Retention Requirements for Decentralized Clinical Trials
The guidance highlights the importance of having a physical location where all clinical trial-related records can be accessed, and trial personnel can be examined. Specifically, it states that for inspection purposes, there must be a physical location where all clinical trial-related records for participants under the investigator’s care are available, and trial personnel can be assessed. This location should be indicated on the Form FDA or, for investigational device exemption (IDE) applications, included in the IDE application. This point is noteworthy as it implies that even in fully decentralized trials, there will always be a designated “site” for record retention and FDA inspection.
Data Variability and Trial Design in Decentralized Clinical Trials
The FDA acknowledges that DCTs may exhibit greater data variability, particularly when compared to approved control drugs tested in traditional study models. To mitigate this issue, the guidance recommends consulting with the FDA on appropriate trial size and design.
Remote Visits and Telehealth in Decentralized Clinical Trials
Telehealth has been approved as a remote option in DCTs, with the protocol outlining which visits can take place remotely. The guidance also requires an identity verification process for remote patient management. Notably, the FDA distinguishes this verification process from the one needed for Part 11 compliance, allowing study staff to use their usual methods for verifying a patient’s identity.
While the guidance clarifies that home health visits are permitted, it does not address the broader oversight issue. It is relatively straightforward for a PI to vouch for oversight of home health staff when they are directly contracted and employed by the PI’s organization. However, these agencies are increasingly contracted by sponsors for remote deployment. If home health staff must be included on the DOA log, this could lead to resistance from IRBs and local PIs concerning their use. Unfortunately, patients are the ones who suffer most from the lack of home health options in the end.
Digital Health Technologies in Decentralized Clinical Trials
The guidance states that all digital health technologies used in DCTs must be validated per the requirements of the agency’s earlier Digital Health guidance. Further, the FDA endorses the use of a patient’s own technology, aka Bring Your Own Device (BYOD) trials, but cautions that sponsors should have backup options available for those patients who do not have access to their own tech. The intent being that they do want to exacerbate any potential recruitment gaps by inadvertently excluding patients based on resource availability.
Roles and Responsibilities in Decentralized Clinical Trials
In DCTs, sponsors and investigators maintain the same roles and responsibilities as in traditional trials. However, the guidance stipulates that sponsors must clearly outline which DCT modalities are acceptable for use in the study protocol. This aspect is intriguing, as it somewhat limits the provider’s autonomy at the site to determine the best methods for their patients. If sponsors do not take all potential options into account when designing the protocol, some investigators may be unable to utilize home health or telehealth. This shift emphasizes the need for more collaborative and deliberate protocol design upfront to avoid unnecessarily restricting the patient pool later on.
Furthermore, the guidance states that standard of care procedures can be performed by local healthcare providers without being included on the 1572 or delegation of authority (DOA) forms. Although this concept is not entirely new, it is a more assertive clarification compared to previous guidance. The introduction of the “Task Log” to document these providers and the procedures they performed for the study is a notable change. This added layer of record-keeping, distinct from the DOA, may spark further discussion on its necessity.
While the FDA’s DCT guidance provides valuable insight and addresses certain concerns, it also brings new questions to light. As the industry continues to adapt and evolve with these guidelines, further clarification and potential revisions are anticipated in the near future. The guidance undeniably marks progress towards embracing decentralized clinical trials; however, addressing remaining challenges and ensuring the successful implementation of this groundbreaking trial model still demands concerted effort and collaboration among all stakeholders.
About Catherine Gregor
Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. She currently serves as the Chief Clinical Trial Officer for Florence Healthcare, a software company focused on connecting sponsors and sites worldwide. Catherine is a subject matter expert and key opinion leader on patient-centric, decentralized and hybrid trial design. She has worked in multiple therapeutic areas in both academic and community hospitals, with her most recent appointment being Director of Clinical Research Administration for the Vanderbilt-Ingram Cancer Center. Additionally Catherine serves in leadership roles in numerous industry associations including Chair of the Site Enablement League, board member for the Association of Clinical Research Organizations (ACRO), member of Association of Clinical Research Professionals (ACRP) Workforce Innovation Board, Clinical Trials Transformation Initiative (CTTI) and others. She is passionate about changing the clinical trials industry and empowering women as leaders.