Most sponsors think decentralized clinical trials are about convenience: fewer site visits, faster recruitment, and better access. But in reality? Decentralization is changing everything about clinical trial execution — and not always in ways that are easy to manage.
- Digital tools bring more data — but not always better data.
- Remote visits offer flexibility — but often widen inclusion gaps.
- Fewer on-site visits reduce costs — but also remove oversight.
And regulators? They’re watching all of it.
Decentralized clinical trials are changing how studies are designed, monitored, and evaluated — from eligibility to submission.
That shift doesn’t just affect how clinical trials are managed — it quietly introduces new risks. And unless those risks are addressed early, they can show up where it matters most: in the clinical trial’s endpoints, timelines, and regulatory outcomes.
In this first part of our two-part series, we explore two of the most overlooked challenges sponsors face in decentralized clinical trials: data quality, patient acess and diversity.
1. Data Monitoring and Quality: Remote ≠ Risk-Free
Decentralization doesn’t eliminate complexity. It simply shifts it — from on-site coordination to data pipelines, system integrations, and digital oversight. Clinical trials that used to rely on paper forms and site visits can now depend on:
- eConsent platforms
- ePROs (electronic Patient-Reported Outcomes) and eCOAs (electronic Clinical Outcome Assessments)
- Wearables and home monitoring devices
- Home delivery of study drugs and remote tracking of shipments, when compliant with regulatory and protocol requirements
- Centralized safety reporting systems
When these systems aren’t integrated or aligned with your protocol’s objectives, then data fragmentation, timing inconsistencies, and loss of traceability become serious risks.
At IDDI, our Biostatistics and Data Management teams work together to ensure remote data is usable, auditable, and aligned with your endpoints, even across multiple systems. We help sponsors design real-time monitoring strategies that flag issues before they trigger protocol deviations or data loss.
2. Patient Access and Diversity: More Reach Doesn’t Necessarily Equal More Inclusion
Even with a robust data strategy, ensuring participation from the patients your clinical trial is designed to serve remains crucial. This is where the promise of inclusion and diversity in decentralized clinical trials can face challenges. While these trials aim to expand geographic and demographic reach, broader access doesn’t always translate into true inclusion. For example, many decentralized clinical trials:
- Underrepresent older adults, rural communities, and individuals less familiar with technology
- Overlook barriers related to digital literacy, language, or cultural differences
- Use poorly designed digital tools that aren’t user-friendly or fail to account for participants’ daily realities
At IDDI, our experts help sponsors go beyond geography. We advise on eligibility criteria, burden reduction for sponsors and patients, and implementation strategies that support real inclusivity from the start. We’ve seen how a well-designed remote strategy can support diversity and efficiency, and how a poorly planned one can silently exclude part of the population it was meant to reach.
Some Final Thoughts on Decentralized Clinical trial (at least for Part 1)
Some sponsors focus on the tools, such as platforms, apps, ePROs, dashboards. And that’s understandable. But the success of a decentralized clinical trial isn’t just defined by the software. It’s defined by the quality of the data you collect, and the patients you engage and support in generating that data.
That’s why the two challenges explored in this post, data quality (including monitoring) and patient inclusion (including access and diversity), are foundational.
If your decentralized clinical trial creates noise instead of insight…
If your tech platform excludes the very people you hoped to engage…
If your tools overwhelm rather than empower patients…
Then your clinical trial isn’t just harder to manage — it’s at risk of failure.
At IDDI, we work with sponsors to address those risks early:
- Designing decentralized strategies that protect data integrity
- Rethinking patient access beyond location
- Aligning endpoints and tools with the realities of the patients you want to reach
Real-world clinical trials demand real-world designs.
👉 In Part 2, we’ll go deeper into the next two critical challenges:
- What regulators expect from decentralized clinical trials
- How to design a decentralized clinical trial that works (across sites, countries, and patient types)
If you’re interested in exploring more, take a look at our Resources Center for more insights and case studies. And if you’re ready to talk about how your clinical trials can benefit from our support, feel free to reach out to me (my email) directly — or connect with one of our experts here. We’d be happy to explore how we can help you move your trial forward!
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