Author: Henk Dieteren, Clinical Supply Chain Solutions Consultant
Snapshot:
- Technology standards diverge: FDA focuses on preventing participant exclusion while EMA emphasizes system validation and alternatives
- Documentation needs differ: EMA requires more detailed and comprehensive documentation for all decentralized elements
- Implementation success requires balance: Effective global trials must satisfy both regulatory frameworks without creating unnecessary complexity
This is the final article in a three-part series on implementing decentralized clinical trials (DCTs) in the EU and the US. My previous articles explored the fundamental approaches and the management of data and drugs in these types of hybrid trials. Here I'll examine how technology requirements differ between FDA and EMA guidance, along with the next steps for sponsors to consider when planning trials.
Digital health technologies reveal different priorities
The FDA and EMA both support using digital health technologies (DHTs) for remote data collection in DCTs, but differ in their approach. DHTs can include solutions like Suvoda eConsent, wearable devices (like smartwatches and fitness trackers), mobile health applications, remote monitoring sensors, and electronic patient-reported outcome tools like Suvoda eCOA that collect and transmit health data outside traditional clinical settings.
FDA promotes DCT adoption with accessibility focus:
- Takes a supportive stance, emphasizing that remote participation can enhance convenience, reduce caregiver burden, and facilitate research on rare diseases
- Prioritizes preventing participant exclusion by requiring sponsor-provided alternatives when trials allow personal devices
- Focuses on device accessibility to ensure no one is excluded due to lack of technology
EMA maintains neutrality while emphasizing validation:
- Takes a more neutral stance on DCT benefits while focusing on comprehensive risk management
- Requires rigorous validation of all digital tools before use and mandates contingency plans for technology failures
- Warns that participants must understand data limitations, noting that investigators may not review digital tool data in real time
- Emphasizes comprehensive validation of participant-owned devices and requires alternatives for those who cannot or prefer not to use digital technology
While the FDA focuses on device accessibility, the EMA emphasizes comprehensive validation of participant-owned devices and requires sponsors to provide alternatives for those who cannot or prefer not to use digital technology, reflecting a more cautious approach to technology adoption.
How to build successful trial strategies across the EU and US
Sponsors running trials across both US and European regions need comprehensive strategies that address these technology differences while supporting successful implementation across regulatory environments. I recommend the following steps:
Step 1: Understand regulatory requirements first
Before designing any DCT elements, sponsors must thoroughly understand which regulations apply and identify the stricter requirements between regions.
This involves engaging with internal quality assurance teams or partnering with specialized vendors who understand the regulatory landscape across both jurisdictions. Without this foundational knowledge, sponsors risk costly redesigns and compliance failures.
Step 2: Design for the stricter standard
When requirements differ between agencies, protocols should aim to meet the more stringent standard (typically the EMA's). This approach can cover compliance in all regions while avoiding the need to create multiple protocol versions. By building in EMA's face-to-face consent requirements and comprehensive documentation from the beginning, sponsors create protocols that work across regions.
Step 3: Address regional differences early
Incorporate regional variations into the trial design phase rather than attempting to retrofit later. Early planning should account for different drug delivery requirements, consent procedures, and technology accessibility needs across regions. This proactive approach prevents costly modifications and delays during trial implementation.
Step 4: Document carefully
Create clear documentation to demonstrate compliance with both regulatory frameworks. This includes detailed risk assessments, comprehensive data flow diagrams, and thorough descriptions of all decentralized processes. Sponsors can develop templates that satisfy the more detailed EMA requirements while meeting FDA standards, resulting in consistent documentation across all trial sites.
Step 5: Engage with regulators
Discuss DCT elements with both agencies during protocol development because early engagement can help identify potential compliance issues and allows for adjustments before protocols are finalized. Maintain open communication throughout the trial to address evolving regulatory perspectives and continued compliance in both regions.
A DCT trial’s success may depend on addressing these differences during initial protocol development, instead of retroactively attempting to modify designs later in the process.
What this means for sponsors and CROs
DCTs can offer significant benefits to trials, including improved participant recruitment, engagement, and retention. By understanding regulatory differences between the FDA and EMA, sponsors can implement decentralized elements that work across regions while maintaining participant safety and data integrity.
The Suvoda Platform addresses both FDA and EMA requirements across multiple areas. Our protocol design expertise supports compliance with both regulatory frameworks, while our products offer the flexibility to adjust based on regional needs, for example:
- eConsent supports electronic signatures or wet-ink PDFs based on regional requirements
- IRT provides encrypted data sharing and flexible, self-service Direct-to-Patient shipment options (allowing patients to conveniently opt in or out, depending on their needs)
- Seamless system integrations streamline DCT data flows across all regulatory environments
The most successful global DCTs will balance innovation with careful attention to regional requirements, helping trials remain compliant while delivering on the promise of more patient-centric research.
As technology advances and regulatory agencies gain more exposure to DCTs, we can expect further evolution of these guidelines. For now, sponsors who understand these key differences can design efficient trials that work effectively across both US and European regulatory environments.
Author
Henk Dieteren
Clinical Supply Chain Solutions Consultant