Part 1 of this series covered two of the biggest challenges in decentralized clinical trials: data quality and patient inclusion while in this second part, we focus on two areas that decentralized clinical trial companies help with and that sponsors often expect to be easier than they really are: regulatory alignment and hybrid clinical trial complexity.
3. Regulatory Alignment: Innovation Doesn’t Mean Less Rules
Some sponsors assume that going digital means fewer regulatory processes. That might be true in some cases, but the truth is, decentralized clinical trials still bring new challenges.
Regulatory agencies like the FDA are issuing clear guidance and paying close attention to decentralized clinical trial aspects, especially around:
- Validity of electronic consent (eConsent)
- Tracking where data comes from (data provenance)
- Reporting safety issues remotely
- Making sure medical devices and digital tools work well together (device interoperability)
- Confirming that data from wearables or apps accurately measures clinical outcomes and meets regulatory standards (endpoint validation)
Thinking regulators will accept any remote approach just because it’s “more patient-friendly” is a risky assumption…
Decentralized clinical trials must be designed to meet evolving regulatory expectations in the US, Europe, and beyond. That means sponsors need to anticipate both the obvious and less expected questions regulators may ask — so their trials are ready from day one. That’s exactly the kind of challenge where our experts on traditional and adaptive design clinical trials (LINK) and on biostatistics for clinical research (LINK) add real value for our partners.
4. Hybrid Clinical Trials: The Future and the Challenge
Most sponsors aren’t running fully remote clinical trials, but they’re moving away from fully site-based models. Hybrid clinical trials, which mix remote and in-person activities, are becoming the norm.
But hybrid doesn’t just mean “add some telehealth.” Without careful planning, hybrid trials can create operational chaos and confusion.
Common issues include:
- Different ways of working across countries and sites (this creates significant operational complexity and inconsistency)
- Confusing patients about when they need to visit a site and when to stay home
- Monitoring challenges when site and remote data don’t connect that easily
Sponsors designing hybrid clinical trials MUST find a path that balances scientific accuracy, operational feasibility, patient convenience, and safety and monitoring needs.
And that means answering some questions, like:
- Which parts of the clinical trial can be done remotely?
- Where are in-person visits essential?
- How do you deliver a consistent patient experience across all study sites — without compromising timelines or data quality?
These are high-stakes decisions. Getting them even slightly wrong can lead to protocol deviations, data gaps, or patient confusion — and fixing them later often costs much more.
Decentralization Is Here. Just Have to Make It Work.
Making decentralized or hybrid clinical trials work isn’t about piling on more technology. It’s about designing smarter trials that:
- Respect real-world patient needs
- Protect clinical trial data quality and interpretability
- Align with evolving global guidance
If you’re designing (or rethinking) a decentralized clinical trial and want to avoid the common challenges we’ve covered here, reach out to me directly, or connect with one of our clinical trial consulting experts. Our clinical trial services will help you build a trial that’s practical, compliant, and built for the real world!
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