Meeting FDA Standards for Decentralized Clinical Trials

In September 2024, the U.S. Food and Drug Administration (FDA) released its final guidance on Conducting Clinical Trials with Decentralized Elements (DCTs). The guidance clarifies how decentralized clinical trials can incorporate remote visits, telehealth visits, and activities conducted at participants’ homes while maintaining patient-centric trial design, participant safety, and data integrity.
For sponsors and stakeholders conducting clinical investigations across traditional clinical trial sites and decentralized models, the FDA guidance provides clearer expectations around informed consent, trial oversight, and regulatory compliance. For 20/20 Onsite, these updates reinforce the importance of accessible, compliant trial models that support modern clinical research and evolving FDA standards.

Key Highlights of the FDA’s 2024 Guidance on Decentralized Trials

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 complexity and variability, MRUs improve trial feasibility and scalability, offering sponsors a streamlined path to compliance under the FDA’s guidance document for conducting DCTs. For 20/20 Onsite, this enables investigational products and clinical trial–related activities to be delivered closer to the patient population, reducing reliance on the traditional site and unnecessary in-person visits.

Our fleet of MRUs supports trial personnel with standardized workflows, safety monitoring plans, and consistent clinical practice to help sponsors manage enrollment, patient follow-up, and data integrity while aligning with the FDA’s focus on participant safety and regulatory 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 broadens participant demographics and strengthens trial representativeness, aligning trial protocol execution with FDA guidance for industry, IRB expectations, and decentralized trial design.

3. Upholding Data Integrity and Trial Safety

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 helps sponsors align with FDA guidance, supporting compliant DCT design, accurate safety profiles, and regulatory approval.

FDA Guidance and the Future of Decentralized Clinical Trials

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

Partner with 20/20 Onsite for FDA-Aligned Decentralized Trials

At 20/20 Onsite, we offer sponsors a proven model for integrating decentralized trial elements, from protocol consultation to on-site and mobile 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 with FDA-aligned decentralized research solutions.