Is the digital experience responsible for failing clinical trials?

For all the structure and science that goes into a clinical trial, the real engine on both sides is hope.

The patient hopes for a better future, for themselves or others with their condition. The sponsor hopes for success, for approval, for data that proves the molecule works.

Both want the trial to succeed. And both have something deeply human at stake.

At the centre of it all, the patient is asked to contribute regularly. Not just attendance or adherence, but their feelings and lived experience, captured through what are known as patient-reported outcomes (PROs).

PROs are a critical part of how a treatment is understood to be working - not just clinically, but personally. They capture pain, fatigue, anxiety, daily functioning, and overall quality of life - elements that can’t be seen in a scan or measured in blood.

In many trials, especially in oncology and CNS (Central Nervous System) studies - PROs are used as primary or secondary endpoints. They can make the difference between regulatory approval and rejection. Between payer confidence and reimbursement denial.

But here’s the catch: PROs are emotional. They’re subjective.

And if the method of collecting that data, from the visual design to accessibility and even the question format and language, isn’t carefully considered, the quality of the data captured is put at risk.

In clinical research, particularly in studies that rely on patient-reported outcomes, the act of asking for data can subtly alter the experience being measured.

This is the observer effect applied to patient experience: measurement isn’t neutral. It shapes attention, perception, and memory.

A patient may begin to view their condition through the lens of the form they’re completing. If they’re asked daily about pain, fatigue, or anxiety, it can heighten their awareness of those symptoms, or even amplify them. Conversely, if the questions are poorly worded, too generic, or misaligned with their lived experience, they may disengage or underreport.

From a UX perspective, the design of the interface plays a critical role in this dynamic:

So it’s not just what we ask, but how we ask it - visually, emotionally, and structurally, that affects the quality of the data.

This is why UX design in data capture tools isn’t just cosmetic, it’s foundational to scientific integrity. When poorly designed tools distort how patients engage with their own experience, we risk collecting data that reflects the system more than the person.

Beyond design, volume of data is a question worth asking at every stage of trial design: are we collecting this data because it’s essential, or because we haven’t stopped to question the cumulative burden?

Digital diaries, symptom trackers, and eConsent flows often play a critical role in trial integrity. But even well-intentioned tools can become overwhelming - especially for patients in palliative care or managing complex comorbidities.

We talk about burden as a compliance risk. But it’s also an ethical issue. If your platform is compliant but exhausting, you’re not building trust - you’re burning it.

And with so much at stake - both financially and clinically - this is not a side issue. Clinical trials today are governed by robust frameworks: CDISC, 21 CFR Part 11, GCP. These ensure rigour, traceability, and auditability. But none of these frameworks ask how it feels to be on the other side of the screen.

I’ve no doubt that there are trials in which these factors are considered. I’m also aware that PROs are only a part of the data points captured, but I’m confident that there’s an opportunity here - and one that deserves attention.

I recognise how complex and tightly regulated these studies are, however I am convinced that trials that invest in participant-friendly UX would see better retention, greater compliance and ultimately more accurate data. And with better data, the performance of the treatment will be more clearly understood.

From a user experience perspective, there are principles I'd recommend:

1. Test with patients. Test questions and the data capture interface with real participants and observe how they complete the data - before finalising either.
2. Reduce the load. Ask only what really matters clinically. Fewer questions, better focus.
3. Design for emotion. Tone, timing, and context matter, especially when patients are unwell.
4. Support participation. Onboarding, help, and human feedback make digital tools usable.
5. Build for real life. Design for the messy, tired, mobile moments, not just ideal ones.

Whether you’re building a trial, an app, or a healthcare platform, the same universal principles apply in data capture:

• Capture only what’s meaningful. Every data point should earn its place.
• Support the emotional context. Patients aren’t users in a vacuum - they’re people with emotions and likely in pain or discomfort.
• Remove unnecessary friction. Good design fades into the background. Bad design becomes the story.

When something is observed, it changes. So let’s make sure the way we observe - and the way we ask for data changes things for the better.