Clinical studies have traditionally required participants to come to the trial’s site. But we’re now seeing a shift towards executing more flexible and patient-centric research, leveraging technology and other strategies to facilitate trial participation regardless of location.
‘Hybrid’ trials (where some but not all trial activity takes place on site) and fully decentralised clinical trials (DCT), whereby all trial activity takes place remotely or at locations other than trial sites, are becoming increasingly common. For example, trials could include telehealth visits with trial personnel, in-home visits with remote trial personnel or visits with local healthcare providers (HCPs).
A DCT offers a more patient-centric approach to clinical research by bringing the clinical trial, or some component of it, to the participant.
The pros and cons of decentralised clinical trials
DCTs promote patient engagement and retention by making trials more convenient for participants — giving patients more flexibility and lowering the participation burden, including for caregivers.
Equally, DCTs promote diversity, equity and inclusion by expanding trial access to more diverse patient populations and a wider geographical reach. This is particularly important in facilitating research on rare diseases and diseases affecting populations with limited mobility.
With DCTs, it’s also easier to collect real-time data, enabling swift identification of safety signals. Real-time data improves trial efficiency by facilitating adaptive designs and immediate decision-making whilst maintaining high data quality and compliance with regulatory standards.
However, conducting DCTs also comes with challenges.
Coordinating trial activities across multiple locations or overseeing remote trial activity can be difficult. Sponsors should also ensure data integrity and maintain patient privacy during remote research processes. Additionally, sponsors must ensure both patients and clinical trial staff understand and have access to the relevant technology.
The latest FDA guidance
As part of a multifaceted FDA effort to help modernise clinical trial design and conduct, the FDA has provided guidance on DCT implementation, emphasising key regulatory and compliance requirements.
The final guidance, which builds upon a prior draft guidance document issued in May 2023, provides valuable insight into a host of issues implicated by decentralised clinical trials, formalising the agency’s expectations for how sponsors can use decentralised elements without sacrificing quality or compliance.
The FDA’s guidance makes it clear that whilst decentralised elements may increase trial accessibility, they also require enhanced oversight to ensure trial data remains reliable and patient safety is preserved.
By continuously assessing the risks that decentralised elements introduce, sponsors can adjust their monitoring strategies accordingly. Timely risk detection and mitigation are crucial, particularly when trial personnel are not physically present to oversee procedures or monitor investigational product administration.
You can read the full guidance document here.
At TMC, we have been conducting trials with decentralised elements for decades. As such, we understand smaller patient populations create significant challenges in the design and execution of clinical studies for new therapeutics. Contact our team today at +44 1252 842255 or info@tmcpharma.com to learn how we can help you set up and conduct decentralised clinical trials effectively.