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In rare disease trials, “non-compliance” is a clinical term for a very human reality.
A participant misses a dose. Not because they don’t want the treatment to work, but because life happens. Maybe the side effects on a Tuesday morning make it difficult to start the day. Maybe they feel overwhelmed by the mental load of being a patient 24/7, alongside work, family, and everything else life demands.
The issue isn’t just the missed dose. It’s the silence that follows.
In clinical trials, particularly in rare disease, medication adherence is often treated as a binary outcome: doses were either taken or they weren’t. But for participants living with complex conditions, adherence is rarely that simple.
Missed doses can reflect:
• fluctuating side effects
• changes in routine
• or moments where life simply gets in the way
Labelling these moments as “non-compliance” risks missing the bigger picture. In many cases, participants are still engaged, still motivated, and still committed, but they need support, not judgement. Too often, adherence issues are discovered retrospectively, weeks or months after they occur. By then the opportunity to understand why the non-adherence occurred, may be lost. This isn’t just a patient experience problem. It’s a trial design problem. Retrospective adherence data limits a study’s ability to investigate and intervene early. However, what’s missing isn’t more surveillance. It’s better listening.
True visibility into dosing patterns, as they happen, changes the role of adherence data. It stops being about catching mistakes and starts becoming a way to open conversations. Instead of asking: “Why didn’t you take your medication?” Trial teams can ask: “I noticed Tuesdays are often difficult. How can we make this protocol work better for your life?”
This shift, from monitoring to visibility, creates space for empathy, context, and practical problem-solving. This is where real-time adherence visibility matters.
Solutions like Pill Connect are designed to provide passive, low-burden insight into dosing behaviour without adding friction to a participant’s daily life. By understanding when and how adherence patterns change, trial teams can respond sooner and more thoughtfully.
That might mean:
• checking in before disengagement escalates
• identifying protocol elements that don’t fit real-world routines
• supporting participants during known high-burden periods
• or adapting trial design to reflect lived experience
The goal isn’t perfect adherence. It’s informed, compassionate support. If we want better data, we need better trial design, and better trial design starts with supporting the person behind the data.
In rare disease trials especially, participants are not just data points, they are navigating complex conditions, uncertainty, and significant emotional and physical demands. Visibility into adherence doesn’t just improve outcomes. It changes relationships. And when trials are designed to listen, not just measure, everyone benefits.