In September 2024, the FDA released its finalized guidance on Conducting Clinical Trials with Decentralized Elements (DCTs). This guidance clarifies and refines recommendations for integrating decentralized components, emphasizing participant safety, data integrity, and patient-centric trial methodologies. For 20/20 Onsite, a leader in point-of-need vision services and research, these updates validate our mission while underscoring the importance of innovative, accessible trial models.
Key Highlights of the 2024 FDA Guidance
The FDA guidance prioritizes participant convenience, enabling trial-related activities through telehealth, home-based visits, and mobile research units (MRUs). By endorsing the use of local healthcare providers (HCPs) for specific trial tasks, the FDA simplifies regulatory processes while preserving data quality.
1. Mobile Research Units: A Critical Asset in DCTs
As an essential decentralized element, MRUs embody the FDA's goal of creating accessible and inclusive trials. These units allow trial sponsors to conduct routine assessments efficiently, leveraging local HCPs without designating them as sub-investigators. This shift reduces administrative demands and accelerates trial timelines.
"The impact of the FDA's transformative guidance is amplified by utilization of MRUs in conjunction with the local expertise of HCPs. 20/20 Onsite's delivery flexibility translates to wider participant diversity and reduced participant travel costs, facilitating improved trial recruitment and retention."
- Pamela Tomic, Clinical Trial Manager
By reducing protocol complexities, MRUs improve trial feasibility and scalability, offering sponsors a streamlined path to compliance and participant engagement. For 20/20 Onsite, this represents a transformative opportunity to enhance clinical trials through our fleet of MRUs, which bring critical assessments and trial activities directly to the point of need. These mobile units reduce logistical burdens while adhering to the FDA’s focus on safety and compliance.
2. Bridging Accessibility Gaps with Provisioned Services
One of the FDA’s key recommendations is providing equitable access to decentralized trials, particularly through sponsor-provided digital health technologies (DHTs) and connectivity solutions. Sourcing tailored clinical solutions, like Mobile Vision Clinics, addresses these needs, ensuring no participant is excluded due to geographic or technological limitations.
“Inclusivity in a clinical trial is imperative to achieving meaningful results that benefit all of us. The FDA's guidelines are an acknowledgement that accessibility is a key component to obtaining a diverse subject pool, and by utilizing 20/20 Onsite's mobile vision clinics, the burden of accessibility is greatly reduced. More people in more communities can participate, and the data gathered more accurately represents the population.”
- Dr. Katherine Harkins, OD
This inclusive approach not only broadens participant demographics but also strengthens trial representativeness.
3. Upholding Data Integrity and Trial Safety
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Decentralized trials introduce unique challenges in data collection and monitoring. The FDA stresses the need for robust risk-based monitoring plans to ensure data accuracy and participant safety. DCT solutions that employ secure, real-time data transfer systems and maintain comprehensive audit trails ensure that ocular assessments and adverse events are captured accurately.
“Data integrity and patient safety are the most integral parts of a clinical trial but also can present some of the most challenging obstacles. With 20/20’s proven model of decentralization, we work with our Information Technology Security and Operations teams to ensure that all patient data is safe, secure, and accurate and that each subject’s safety is maintained.
- Dr. David Gibson, Chief Clinical Officer, OD
This dual focus on data integrity and participant safety allows sponsors to maintain the rigorous standards required for regulatory approval.
Solutions in 2025 for Decentralized Trial Success
The FDA’s 2024 guidance underscores the importance of participant-centric trial designs, positioning decentralized elements like MRUs as vital to advancing clinical research. The FDA’s guidance reflects a broader trend toward decentralized and patient-focused clinical trials. By embracing these updates, sponsors can enhance recruitment, retention, and diversity in their studies and clinical programs.
“The FDA guidance signals continued support for DCTs and outlines comprehensive practices to address associated regulatory issues. While FDA reviews of protocols will further clarify emerging novel elements raised by DCTs, it is expected that sponsors will continue to incorporate decentralized elements into research. 20/20 Onsite's experience with conducting clinical trial assessments with a variety of decentralized visit options positions it for this significant trend.”
-Pamela Tomic, Clinical Trial Manager
Decentralized Solutions Start with 20/20 Onsite
At 20/20 Onsite, we offer sponsors a proven model for integrating these elements, from protocol consultation to onsite implementation through our state-of-the-art Mobile Vision Clinics.
By prioritizing participant convenience and trial efficiency, we are driving a transformative shift in clinical research. Sponsors working with 20/20 Onsite can confidently align with the FDA's latest recommendations while meeting the demands of modern trial participants. We are committed to supporting this evolution with innovative solutions that balance participant needs with regulatory requirements.
Contact us to learn how 20/20 Onsite can help your trial succeed in this new era of decentralized research.