Is the patient voice in the DNA of your trial?

Harnessing the power of patient engagement can transform your clinical trials performance. Patient engagement is essential, not only to gain research approvals from UK Research Ethics Committees (RECs), but also to improve trial design and recruitment from the outset. Emily Pickering, Specialist Commercial Services Lead at the NIHR, reflects on the power of the patient voice in clinical development. 

There is no substitute for hearing a patients’ first-hand experience of living with a health condition or disease. Their perspective often surfaces valuable insights that researchers based within life science companies could easily overlook. 

In my role leading our Patient Engagement in Clinical Development (PECD) service, I routinely see how gems of wisdom emerge from the patient or carers' personal experiences to help to refine trial design, improve recruitment strategies, or make long term participation in a trial feel more acceptable for participants.

The service is designed to enable and support life sciences companies and public contributors to engage in direct dialogue. As well as ensuring potential participants' voices are heard, our service is also geared towards ensuring compliance with regulatory standards, such as Research Ethics Committee (REC) approval and the ABPI Code of Conduct regarding patient and public involvement activity.

I feel privileged to be part of those conversations, seeing the difference they can make, and everyday I am astounded by the commitment and passion of the public contributors I work with. 

Small changes can have a big impact

Take Helen for example - a passionate patient advocate who believes early patient input leads to more effective trials. She explains: “It’s really important to me that the patient's voice is in the DNA of a trial from the very start—even when defining the question or working out whether it’s a priority for patients.” Helen also believes that, "When trials are designed with patient input, they’re more meaningful and relevant. Patients feel heard, and the research becomes more effective and inclusive.” 

Helen understands that seemingly small details can make a big difference to patients when they are offered an opportunity to participate in a trial. She has been working with our PECD service to ensure clinical trial information leaflets and consent forms are fully transparent and easy for patients to understand. She adds: 

“We need to close the gap between research and real-life patient experience. Educating people about clinical trials, their risks, and benefits is so important. Patients must feel empowered to make decisions that work for them.”

Diverse perspectives

Public contributors bring diverse backgrounds and experiences. Like Helen, some have lived with the conditions being studied, and others have cared for someone with a condition. This means they have unique and invaluable insight into the challenges patients and carers face when considering trial participation.

They are experts in identifying obstacles in a trial design and instrumental in reviewing and simplifying patient-facing documents. Consent forms, information sheets, and recruitment materials often contain complex medical jargon that can feel intimidating. Our public contributors quickly spot these complexities and offer solutions to help ensure these documents are clear, concise, and written in plain language, empowering patients to make informed decisions about their participation.

Steve, another one of our public contributors, strongly believes that the documents need to be understood the first time they are read:

“You shouldn’t need to Google unfamiliar terms - the plain English summary should be exactly that - in plain English - and should set the tone and be easily digestible."

Reaching underrepresented groups

Steve also believes that it’s not just about simplifying language but about ensuring that the materials speak to a wide audience:

"I always read documents from my perspective, but then think about how my elderly relatives would interpret it. I want it to be clear for everyone."

By being involved in the study design process, public contributors play a vital role in ensuring that clinical trials are inclusive, representing a diverse range of demographics. Their involvement helps overcome biases towards certain groups, ensuring trials are accessible to people from all backgrounds, including those from lower-income communities, ethnic minorities, and those with disabilities. This inclusivity is crucial for developing treatments that will benefit a wide range of patients and help tackle health inequalities.

Translating patient and public insight into action

For commercial sponsors and Contract Research Organisations who work to tight timelines and need clear and actionable feedback from patients and the public, our PECD service has proven to be a powerful tool. 

ICON recently used our service to gather feedback on clinical trial materials for an oncology study. The goal was to ensure the materials were clear and comprehensive while meeting the UK Health Research Authority’s (HRA) requirements for participant clarity and accessibility, which are critical for obtaining informed consent.

The process was streamlined and efficient. ICON’s Senior Study Start-Up Associate, Nailah Firdaws, commented on our transparent and pragmatic approach: “We never need to guess or interpret the reviewer feedback. There are very clear suggestions for areas that we can improve.” 

This led to faster approvals and better outcomes. As Nailah explained, “When we incorporate these changes and clearly state in our application that these were based on feedback, we’ve found that there are fewer queries from the Ethics Committee. This leads to quicker approval and less time spent on updating documents.”

Read more about ICON’s experience of our PECD service.

Similarly, for Amgen, a global biopharmaceutical company, the PECD service helped them quickly gather feedback from parents of paediatric dialysis patients to improve consent documents. Faced with tight timelines, Amgen valued the flexibility of the service which adopted a new approach and provided phased feedback. This enabled the Amgen team to make changes swiftly without compromising quality. Matthew Rodaway, Senior Manager for Development Operations at Amgen commented: 

“The new format is clear and actionable, making it easier for us to implement changes. The ability to receive phased feedback really helped us balance urgency with quality."

Read more about Amgen’s experience of our PECD service.

These insights from the patient engagement sessions are now being applied across Amgen’s global operations. We're now also working with other commercial sponsors in a similar way, not just to shape one trial, but to embed a more patient-centred mindset into whole programmes of research.

None of this would be possible without the commitment and passion of our public contributors. These people, who devote their time and energy into ensuring their voices are heard, understand the difference they make. So  I’ll leave you with words from another one of our contributors:

"It’s so important that researchers hear from people like me—people who’ve lived through these challenges. 

"It’s not just about ticking a box; it’s about making research better for the people it’s supposed to help."

“And knowing that you’ve helped make a difference feels really rewarding."

Our Patient Engagement in Clinical Development Service helps life science companies to connect and collaborate with patients and the public to design participant-friendly clinical trials. 

Access end-to-end support through the Industry Hub

The Industry Hub is our single operating model for commercial clinical research delivery. Our PECD service is just one of the ways that we support you to deliver trials that are predictable, faster and more inclusive. Contact the Industry Hub.