From Passion to Profession: 15 Years of Humanising Clinical Trials

ISPEP CEO Alex Charge reflects on our collective journey towards patient-focused clinical trials and shares how ISPEP is helping to drive what comes next.

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On this year’s Clinical Trials Day, I find myself reflecting not just on how far clinical research has come, but also how we’re finally beginning to see the outcomes of something many of us have known for decades: that trials work best when they are developed with the very people they aim to serve. However, we still have a long way to go.

The journey so far

Fifteen years ago, I sat in a meeting where the term ‘patient centricity’  was used for the first time in our clinical development programme. A perceived new “innovation”, where at the time it was hailed as disruptive to suggest that patients should have a voice in shaping how studies were run.  However, in reality, this had already been a passion of mine and many others for a considerable amount of time. The industry was finally starting to catch up.

In my many years in global Clinical Operations, I committed to bringing patient voices into every aspect of my role to make the trials work for them and reflect their lives. This was even before we formally launched the “Trial to Patient” (T2P) initiative, one of the pharmaceutical industry’s first global patient centricity programmes in R&D. That experience crystallised what I already knew: to humanise clinical trials, we must ask the question: does this trial make sense for the patient? 

Fast-forward to today, and patient engagement is now relatively mainstream. This didn’t happen by chance, but thanks to those committed to evolving this practice – the patient engagement professionals (PEPs) and the patients themselves (and indeed, many people “wear both hats” here). Embedding myself in the community of PEPs and innovators, I’ve spent the last two decades helping drive that shift, working across pharma sponsors and industry initiatives to bring strategic innovation and humanity into how we design and deliver clinical trials. 

In those early years, advocating for patient-led trial improvements often felt like swimming upstream. But over time, momentum grew. Industry began to see that better trial experiences led to faster recruitment, better data, and more representative results.

However, while we’ve come a long way in acknowledging the value and practice of patient-focused drug development, the people driving it have too often been under-recognised and structurally siloed.

ISPEP exists to change that. 

The future is professionalised patient engagement: How ISPEP is redefining medicines development

For patient engagement to truly transform clinical trials, it must be treated not just as a passion or a principle, but as a profession that embeds patient engagement as a core operating, systemic transformation. 

That’s why, in 2024, Emma Sutcliffe and I launched ISPEP: the International Society for Patient Engagement Professionals.

Our mission is to define and support the role of patient engagement professionals, the people translating insight into impact across trial design, execution, and lifecycle engagement.

ISPEP is building the frameworks, training, and global community that this profession requires to deliver measurable value through truly viable protocol designs, better patient experiences, and ultimately, faster, fairer research outcomes, making trials more accessible, inclusive, and human.

In this huge industry with high expectations from countless powerful stakeholders, it’s not enough to have passion. We need pathways, competency frameworks, recognition, standards, and methods for demonstrating return on investment. Patient engagement must be embedded not just as an idea, but as a discipline with measurable contributions to study success, regulatory expectations, and patient experiences of and trust in research and care. ISPEP was established to fuel this evolution. 

Why this matters for the future of clinical trials

The future of trials is flexible, hybrid, data-driven, and increasingly personalised. Through these technological advancements, it is imperative to retain and renew our focus on patient-centred design through asking questions such as:

• How can we use evolving technologies and approaches to better reflect the complexity of real life in trial environments (and therefore generate more useful data)?

  
  

• What solutions are becoming available to help us better include under-represented communities in clinical trial design and execution?

  
  

• How can lived experiences be best crystallised into actionable, influential datasets?

  
  

Please do let us know your thoughts on these questions in the comments section below – we would love to hear from you.

Technological evolution is exciting. But in embracing change, we mustn’t lose sight of the essential humanity of medicines development. To protect this, patients and patient engagement professionals must be considered essential partners in the evolution of clinical trials.

A personal commitment and a global movement

Coming back to this year’s Clinical Trials Day, I’m proud to be part of an industry that’s evolving, and I am committed to drive this evolution through leadership of ISPEP. However, I reflect not only on how far we have come, but also how far we still have to go in delivering clinical trials that are genuinely and consistently patient-focused. I also consider how emerging technologies could shift not only the paradigms for doing so, but also the possibilities previously only dreamed of.

Today and every day, I celebrate not just the science of healthcare, but the people. The patients sharing their experiences and insights. The medical professionals constantly pushing for better at the frontlines. The patient engagement professionals striving for systemic change behind the scenes.

Together, let’s continue building a world where clinical trials don’t just test pipeline products, but deliver meaningful healthcare solutions for all.

What are your hopes and ambitions for the future of patient-focused clinical trials? Let us know in the comments below!