As biotech sponsors and CROs ramp up post-pandemic R&D, decentralized clinical trials (DCTs) are again at the center of industry debate. Originally hailed as a revolution in patient-centric research, DCTs promised reduced dropout rates, improved enrollment, and enhanced diversity. But in 2025, the question has evolved: are DCTs really solving the operational bottlenecks sponsors hoped they would?
Why DCTs Are Still a Hot Topic
A recent LinkedIn poll among clinical operations leaders showed nearly 60% still plan to expand decentralized components over the next year. But this enthusiasm exists in tension with ongoing concerns:
- Data fragmentation across digital health tools
- Site resistance due to training and workflow challenges
- Regulatory ambiguity across borders
Biotech companies aiming to track trial momentum must now ask: are DCTs accelerating trial timelines, or simply shifting complexity?
FDA and EMA: Diverging Signals
In the U.S., the FDA’s draft guidance on DCTs issued in late 2023 emphasizes fit-for-purpose design, stating: “Decentralization is not one-size-fits-all.”
Meanwhile, the EMA continues to assess decentralized elements under its Accelerating Clinical Trials in the EUinitiative, but with cautious progress on remote monitoring.
This divergence creates decision risk for global sponsors who must design trials that align with both sets of regulations — especially in multi-region oncology or rare disease studies.
Who’s Getting DCTs Right?
Leaders like Medable and Science 37 have leaned into hybrid models. Instead of fully remote trials, they enable patients to complete certain visits virtually (e.g., ePROs, telemedicine), while still involving investigator sites.
For example, this study on Alzheimer’s combined wearable tracking with in-person diagnostics, increasing compliance while reducing site burden. Hybrid DCTs like these are showing promise in therapeutic areas where consistent patient engagement is critical.
Operational Challenges Sponsors Still Face
Despite the benefits, Trial Managers and BD teams consistently report key friction points:
- Inconsistent data formats from wearables, apps, and remote labs
- Limited digital literacy among trial participants over 65
- Vendor overload — too many platforms with no central orchestration
That’s where platforms like Trialonic can help teams track clinical momentum by unifying fragmented updates across site types and technologies.
What Sponsors Should Do Next
To extract value from DCTs without getting lost in digital noise, sponsors should:
- Start with the protocol – Design decentralization based on scientific endpoints, not tech trends.
- Prioritize interoperability – Use eClinical platforms that consolidate multi-modal data.
- Align with regulators – Tailor monitoring and data capture to the most conservative guidance when going global.
- Track trial momentum – Use real-time analytics to assess whether DCT components are delivering results.
What Sponsors Should Do Next
2025 may be the year we stop treating DCTs as a silver bullet and instead adopt them as tactical tools within a broader patient-centric strategy. The sponsors who succeed will be those who use data — not hype — to guide decentralization.
Ready to track clinical momentum in your DCTs? Book a demo with Trialonic today.
