Designing with patients in mind: How to build more inclusive clinical trials

“Recruiting for clinical studies isn’t that hard. What makes it hard is poor study design that doesn’t consider patients’ real lives.”

This was an offhand comment made by a pharma panel participant at a recent conference we attended. The conversation quickly moved on but it struck a chord, because when you look closely at many of the barriers to trial recruitment and retention, they’re rarely about willingness. Often, they’re about fit. The design doesn’t fit the lives, needs or realities of the people it’s meant for.

So how do we change that?

The answer starts with listening. Listening to the people who live with the condition day in and day out. People with different backgrounds, responsibilities and experiences. People who know exactly what would make it easier, or impossible, to take part.

And crucially, using what we hear to shape trial design from the start.

Building trials around people, not just protocols

When trials are designed in ways that reflect real life, they become easier to join, easier to stay in, and more meaningful for everyone involved. But too often, protocols are shaped in a vacuum: clinically rigorous, yes, but disconnected from the everyday challenges of life with a long-term condition.

Understanding those challenges means speaking to people who’ve lived them. It’s about asking:

• What makes taking part harder or easier?
• What kind of data collection feels manageable – and what doesn’t?
• What kind of support would make a real difference?
• Are the things we’re measuring actually what matters to you?

In a recent patient interview for a migraine study, one participant told us she simply couldn’t complete ePRO forms on her phone during a flare. Her vision was too impaired. The format didn’t work when she most needed it to.

It’s a small detail, but it makes a big impact. And it’s the kind of insight you can only get by listening directly to those with lived experience.

More voices, stronger design

There are many ways to connect with patients. Working directly with individuals and support groups is essential. But partnering with patient advocacy groups (PAGs), local organisations and community leaders can help widen that net. Many have strong grassroots networks that can share information in ways that feel personal and authentic, not clinical or transactional. Investing time into building trust and using local networks boosts engagement and improves access to research.

These partnerships bring rich insight into the different cultural, economic and personal factors that influence someone’s ability to take part in research. They can highlight:

• Barriers to access, like transport, time or digital tools
• Communication gaps or language needs
• Local priorities or perceptions that may affect trust or interest

They can also help shape more relevant endpoints and patient-reported outcomes, so that the data you gather doesn’t just satisfy regulators – it also captures what really matters to patients. And when research is visible, relevant and respectful, people are more likely to get involved.

But visibility is just one part of the puzzle. If trial designs still ask too much, offer too little flexibility or ignore practical challenges, people will still struggle to take part.

Supporting people to stay

Taking part in a trial takes time, energy and often sacrifice. If we don’t recognise that upfront, we risk high dropout rates and low engagement.

Simple changes can help:

• Flexible appointment times
• Options for remote or home visits
• Travel support
• Clear, regular communication
• Feedback loops that show how input is acted on

These kinds of choices show people that they’re valued partners, not just data points. And that sense of respect makes all the difference.

Getting the most from patient involvement

If you’re bringing in partners or representatives, whether individuals or groups, there are a few ways to ensure it’s meaningful:

• Involve them early, ideally before the protocol is final
• Pay fairly for their time and input
• Offer training or support if needed
• Be open about how their insights will be used
• Share outcomes and show the impact of their voice

As both the FDA and EMA have made clear, patient involvement isn’t just a ‘nice to have’. It’s essential to creating research that reflects real-world need.

We’ve seen the difference this makes through our recent patient research, run in partnership with ISPEP. From the very beginning, patient voices shaped the questions we asked, the way we asked them, and the outcomes we focused on as we have continued to uncover the truth about the clinical study patient experience.

The result? Studies that are more inclusive, more responsive, and more grounded in lived experience. Because when people feel seen, heard and supported, patient engagement is not just a box-ticking exercise – it becomes a core part of bringing a new treatment to market to support the patients that need it most.

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