Empowering Patients: A Guide to Co-Creating Supportive Clinical Trial Material

Understanding the Patient’s Perspective

In communications and marketing, the rule of thumb is to appeal to audiences by putting yourself in their shoes. It’s relatively easy when targeting groups with common traits, like Gen Z or baking enthusiasts. But what about patients, particularly those considering or participating in a clinical trial? Theirs is more unique pair of shoes to step into, shaped by many factors including individual health conditions and the complexities of the trial itself.

Talking to Patients Directly is Key

 To truly understand what patients or potential trial participants need, we need to talk to them. Recent industry shifts are acknowledging this approach. We’re finally moving away from a world where participants are lucky to get a thank-you note after two years of service, towards one where engagement happens before trial participation, and is sustained over its course.

If patients are not consulted at protocol stage, then it is - at best - optimistic to expect to create a study that optimises the experience (or at least minimises the burden). There will always be aha moments that only proper patient engagement can uncover. For instance, “reimbursed travel” if “travel” is assumed to be a physical and financial consideration only. An overactive bladder patient, a schizophrenia patient and a vitiligo patient all have very different – but equally legitimate – reasons not to want to get on a bus.

When it’s time to reach out to patients – and if you’re planning a trial, it’s time  – then we recommend keeping FOCUS:

Friendly – be approachable, and human, in your tone.

Open – offer all explanations, and answer all questions.

Convenient – visualise the patient’s calendar. Take as little of it as possible. 

Uncomplicated – eliminate jargon, explain science.

Supportive – always ask what patients need. Then act on it.

Industry-Wide Momentum for Patient Engagement

 We’re seeing more clients receptive to research and advisory boards as part of their strategies. A 2023 report, Using Patient Perspective to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions, discusses the evolving approach to patient engagement in drug development. Factors driving this change include the ‘complexity of innovative drugs and the need to demonstrate outcomes of relevance to patients’ and ‘an increasing societal demand for diversity and inclusion, and efforts to improve clinical trial efficiency, transparency, and accountability’.

Why Trust and Clarity Matter in Clinical Trials

 When patients understand and connect with clinical trial materials, it builds trust — a priceless and historically scarce commodity in pharma-patient relationships. Trust opens the door to action and engagement. In clinical trials, where the understanding of tasks and instructions can affect both results and safety, knowing what participants need to understand those tasks and instructions is critical. It influences recruitment, retention, and, most importantly, helps patients feel supported and in control.

 A study from 2019 shows that convenience-enhancing solutions correlate with higher ratings for trial satisfaction, care, and attention. Between that and the industry slowly shifting towards acceptance, there’s no reason to cut patients out of the process.

How to Begin: Steps for Patient-Centred Co-Creation

 1. Incorporate Co-Creation Early in Strategy Ideally, start before the protocol is locked down; patient insights can improve that too. Advisory Boards: Include both patients and clinicians. Patient Feedback: Gather input on trial design, site locations, preferences for physical or electronic diaries, key questions they have, and factors influencing their decision to join. Clinician Insights: Ask clinicians about common patient challenges and areas requiring clarity.

2. Prioritise Health and Digital Literacy in Materials Don’t let precedent hold you back. It’s perfectly possible to shatter the jargon barrier while remaining compliant! Work with reviewers to simplify complex terms and provide reassurance without making unrealistic promises, and employ writers who appreciate the emotional stakes as well as understanding the clinical context. Empathy is essential and is just as important in health literacy. Don’t underestimate the role of smart and engaging visuals to make information digestible and accessible in formats that reach all audience types. Video is the friend of knowledge retention; it’s why we remember lines from our favourite films much more easily than from our favourite books. Representation Through Illustration: Go beyond demographics—consider patient archetypes and their lifestyles to create visuals that truly resonate, and onto which patients can apply their own experience.

For more insights, check out our top learnings from a recent health and digital literacy workshop hosted by the Patient Information Forum. View here.

A Call to Action

We can’t assume we know what a patient considering a clinical trial might need or feel, regardless of our expertise. Engage with patients, adapt your approach, and join the movement towards patient empowerment and true patient integration.