Interview with Nick Medhurst, Head of the Good Clinical Trials Collaborative 

Nick Medhurst has led the Good Clinical Trials Collaborative since the advent of the pandemic. Here, he shares the Collaborative’s work and vision, and how we hold onto lessons learned from COVID-19.

What led you to the Good Clinical Trials Collaborative (the Collaborative) and Protas? 

Nick Medhurst: From the beginning of my career, I was interested in healthcare advocacy and the politics of health. My first role was at a breast cancer not-for-profit based in London. 

I supported them with a fascinating programme called the “Westminster Fly-In”. This was pioneering work when it was first started: busing breast cancer survivors, people living with breast cancer or their loved ones – including bereaved family members and friends – to Westminster to meet MPs and discuss critical issues in breast cancer.  

From there I moved to work in cystic fibrosis (CF). This included collaboratively developing policies to make lung transplants more successful, advocacy work around fair cost and access to treatments, and how to improve the experience of palliative and end-of-life for people with CF. 

I had the opportunity to work every day with people with CF, which helps to keep you focussed on what you are doing the work for. It was also very special to regularly work directly with an amazingly collaborative, multidisciplinary community of healthcare professionals and researchers who really did put the person at the centre of their care.

After that, I wanted to explore work beyond one disease area and saw this role at the Collaborative come up around regulation of clinical trials. I was interested because, in all fields, generating better evidence is one of the most effective ways to support better outcomes for patients. I also liked that the Collaborative was funded by Wellcome Trust and Gates Foundation – two not-for-profits making a real difference to human health. 

I learned more about Prof Sir Martin Landray, who had helped start the Collaborative, and the impact he’d had in kidney disease and cardiology, and his history as a passionate advocate for good regulation that enables good trials. I took on the role in March 2020. 

Due to COVID-19, clinical trials at that time were front page news globally. Why can’t clinical trials go faster? Why can’t we get better information? What counts as good-quality evidence? The pandemic starkly illustrated just how critical sufficiently large, randomised trials are. For perhaps too brief a window, trials and regulation were the hottest topics out there, which was quite amazing really. 

The challenge now is in how to continue the momentum to transform clinical trials – which is fundamental to both the Collaborative and Protas. 

Having the Collaborative housed now within Protas is a perfect fit. Protas wants to embody our principles through its commitment to smart trial design and delivery, effective use of data and technology and collaborative policy development. It’s a great opportunity for the Collaborative’s secretariat team to explore how our efforts can practically help to achieve that. 

What does the Collaborative do? 

NM: First, the Collaborative itself is a broad coalition of people from across the world who share our ambition to make it easier to do good randomised clinical trials (RCTs). We define “good” as informative, ethical and efficient, and our guidance (available here) sets out the principles and considerations that all trials should follow to make choices that help achieve those characteristics. 

We brought together hundreds of people to help us develop our guidance, and it draws upon a really diverse set of experiences and expertise across different sectors. 

My role has been to guide that process to ensure our guidance is clear, thorough and useful to everyone who can benefit from using it. Now the guidance is finalised, I have been working to ensure those core messages are being reflected in key guidelines and to encourage their implementation in all parts of the clinical trial system. 

New developments at the Collaborative include building an e-learning course (to be released next year) and evaluation tool (available here). These resources will help teams and organisations design and run trials with our principles in mind, guiding them to make choices that enhance both the quality of the trials themselves and their results. 

How did the Collaborative’s work inform WHO’s new guidance for best practices in clinical trials? 

NM: The basis of the WHO generating guidance on best practices for clinical trials was at the World Health Assembly in May 2022. 

This was when the impact of the pandemic was still fresh in everyone’s mind globally. It was an opportunity for them to reflect on a system which perhaps people took for granted and assumed that clinical research will be able to rapidly and reliably generate the results we need. 

The real picture in many places was one of fragmentation and disorganisation. There was generally a huge amount of good will and intent but challenges with the design of trials and available infrastructure led to a lot of wasted effort and time. 

It was a real stock-take moment for that whole community – WHO member states of the world and leaders in health around the world – to say we need to make sure clinical trials work better and deliver evidence that we can rely on. That assembly and the resolution on strengthening clinical trials was supported by all WHO member states, giving its subsequent work a massive amount of credibility. 

We were well positioned to support WHO in their efforts and worked collaboratively with them, providing our guidance as a basis for WHO’s official guidance. 

In adopting our work, the WHO guidance shares the characteristics of being a very clear, widely applicable, principles-based statement of what best practice looks like, supported by further valuable considerations and a hugely credible, high-profile, global platform.  
 
What’s next for the Collaborative? 

NM: Our focus will be on further advocacy and support for organisations and individuals to adopt and implement the principles of good clinical trials. With our learning and evaluation materials, we are hoping to make it easier for people to engage with the messages and apply them in their work.  

The upcoming finalisation of the ICH guideline on good clinical practice (GCP) is another opportunity to promote a focus on the principles of good clinical trials. How can those guidelines help users to think carefully about the choices they make? 

Thinking – or thoughtful consideration – is a critical feature of good trials. Thinking about design, protecting the fundamental aspects of a trial to ensure its scientific and ethical integrity, thinking about fitness for purpose, thinking about what is sufficient or appropriate in certain contexts – these are all considerations which help deliver informative, ethical and efficient trials and help generate results which can be relied on to make the best healthcare choices.