Unlocking the power of patient insight to revolutionise clinical trial design

When we talk about clinical trials, discussions often centre on regulatory demands, data integrity, endpoints, and scientific outcomes. While these are undeniably critical, what frequently gets overlooked is the perspective that matters most - the patients. Prioritising advice from regulators, payers, and healthcare professionals can eclipse the realities of what trial participants truly experience. But imagine flipping the script. What if we started by asking the most fundamental question: what do patients genuinely care about? What role does their lived experience play, and how do we design trials that align with their priorities and improve their lives meaningfully? 

This empathetic, patient-centred approach is at the heart of our recent work with a global biopharma organisation. By conducting research with patients across diverse diseases and geographies, we uncovered a compelling truth: patients’ priorities go far beyond clinical outcomes. Their concerns aren’t just about the treatment itself but how it can positively restore their daily lives. 

It’s not all about measurable endpoints - it’s about moments that make life whole. For one individual, it might be being able to follow their morning routine. For another, it’s the simple joy of participating in a family gathering without the anxiety that illness often brings. For others, it might be regaining the ability to complete everyday tasks, like climbing stairs or tidying their home. While these priorities might not feature in protocols or traditional outcome measures, they’re crucial. They shape a patient’s willingness to join a trial and impact their overall experience and well-being during participation. 

The real innovation in clinical trials may well be recognising this: when trials enable healthier, happier lives, they naturally deliver better data, greater patient engagement, and improved clinical outcomes.  

Putting patients at the heart of clinical research 

Unfortunately, we’ve learned through experience that effective patient engagement often happens too late - or not at all - in clinical trials. While frameworks and regulations are in place, in reality, the patient experience remains an afterthought far too frequently. 

But why should medicine development lag behind the principles followed by the world’s leading businesses? Companies like Apple and Nike don’t simply make products; they obsess over their customers, studying their needs and designing exceptional experiences that deliver value and loyalty. The healthcare industry could aspire to something similar but go even further - ensuring patients not only inform and define solutions but that their insights directly shape the experience of advancing medicine. 

With this vision in mind, we partnered with a global biopharma company to demonstrate what’s possible when patient understanding becomes the foundation of clinical development. We collaborated closely with their teams to embed patient insight into every layer of the organisation.  

A new approach to patient-centred clinical trial design 

Our partnership began by establishing a robust patient engagement framework. We developed and updated Standard Operating Procedures (SOPs), created an interactive playbook, and brought together cross-functional stakeholders to co-design new tools and processes. The goal was simple yet profound: reimagine clinical trial design through the lens of real people, not just trial participants. 

One of the pivotal tools in this approach was the introduction of patient Archetypes- empathetic personas that bring patients’ stories, motivations, and hurdles to the forefront of trial design. These Archetypes weren’t invented in isolation but born from rigorous qualitative research: interviews with patients across three disease areas and various markets. Their stories helped us paint vivid pictures of what trial participants truly value. Some were motivated by regaining independence, while others prioritised reducing anxiety, nurturing personal relationships, or overcoming daily physical challenges. These individual motivations shattered assumptions and opened our eyes to how clinical trials could be better tailored for the diverse realities of patient lives. 

We didn’t stop there. Further research across eight countries helped refine these insights into actionable improvements for an upcoming Phase III study. By focusing on patient-centric design, we enhanced foundational components like endpoint priorities, country and site feasibility, recruitment strategies, and data collection tools. Beyond clinical measures, we considered how to transform patient materials and communications - making them accessible, supportive, and responsive to the needs and preferences of real people.  

Transforming clinical data through meaningful patient engagement 

Bringing patient insight into the heart of trial design doesn’t just enhance participants’ experiences; it raises the value of the clinical data itself. Recruitment and retention rates improve, and patient-reported outcomes (PROs) are collected in ways that reflect patients’ actual concerns and lived experiences. The willingness of participants to commit to trials and see them through increases when they perceive that their health and quality of life - not just their symptoms - are being prioritised. 

Critically, engaging with patients isn’t just about a framework or procedure. It’s about the culture we build and the mindset we nurture across entire organisations. Clinical teams need tools and training, but they also need to understand the ‘why’- why patient insights matter, why empathy drives better results, and why bringing patients into discussions from the very beginning is not optional but essential.  

Key lessons for transformative trial design 

1. Embed patients in decision-making: No form, process, or guideline can replace the impact of truly listening to patients and giving them a meaningful role in shaping trials. 
2. Prioritise real-time insights: Understanding the ‘why’ behind patient behaviour requires active listening through interviews and focus groups. 
3. Expand the scope of research: Recognise the diversity of patients. Each market and region has its own cultural and healthcare nuances that influence participation. 
4. Focus on patient experience: The patient’s lived experience must guide trial design - not only to improve recruitment and retention but also to elevate data quality overall. 

When we centre decision-making on the values, fears, and hopes of real patients, we move away from treating clinical trials purely as scientific experiments. We create an experience for participants that supports their health and well-being and offers them renewed hope. That’s how truly patient-focused research achieves its most profound impact, by making trials accessible, inclusive, and transformational. And that, in essence, is what drives clinical trials - and healthcare - forward. Now, that’s innovation. 

To find out more about, please reach out to Louise Evans, Sarah Blunt or Alice Pursell.