Reflections on Clinical Trials Europe 2019

My key takeaways from this year’s conference.

Just as the grey skies in the UK set in for winter, myself and a colleague had the opportunity to spend a few days in Barcelona for the Clinical Trials Europe conference which took place from 19–21 November.

Formerly called ‘Partnerships in Clinical Trials Europe’ (PCT), the conference aimed to “provide a meeting place for all of the key stakeholders to participate in cutting edge discussion” on clinical development, bringing together leaders from industry, patient groups and academic research centres to “share best practices and discuss the new era of technology and patient-centric trials”.

Taking project management seriously when it comes to research

The conference kicked off with a great talk by Stephen Carver from Cranfield University discussing the importance of good change management skills when it comes to running clinical trials. He highlighted that industry too often fail to equip those running clinical trials with the skills they need to manage the complications and complexities that are part of the process, leading to inefficiencies and poor decision-making. The failure rate of clinical trials is high, yet industry are persisting with the same approaches and millions of pounds are being wasted. Drawing on an analogy with the aviation industry, he discussed how trial managers respond to challenges and setbacks, and emphasised the need for industry to take seriously the importance of project management skills in order to improve the success of clinical trials.

The realities of taking part in research

Stephen’s talk was followed by a moving presentation from Stacey Williamson, mum to Frankie who has a rare genetic condition called Dravet Syndrome — a severe form of epilepsy. Stacey shared the heartache the family have been through since Frankie’s first seizure at 4 months old — the process of receiving a diagnosis, the difficulties of learning about and managing a condition that even doctors didn’t fully understand, and the loneliness she experienced. When Frankie’s symptoms were at their worst — for several months the family were practically housebound and living in darkness due to the severity of Frankie’s sensitivity to light — they decided to enrol in a clinical trial. Stacey spoke about the challenges of being on the trial, particularly after it became apparent that Frankie was in the placebo group, and highlighted the invaluable role research staff play in supporting families and trial participants.

The trial continued open label, at which point Frankie received the drug, and since then life has been transformed for him and their family. Stacey spoke with pure joy at being able to take Frankie swimming again, and being able to go on a family holiday to Cyprus where Frankie was seizure free the whole time.

This posed an important question — how do we ensure that outcome measures in clinical trials capture these life-changing impacts? We hear so often from people taking part in trials that the things being measured in the research aren’t the things that really matter to them. Yet the system remains inflexible, forcing researchers to persist in using measures that although validated, are not fit for purpose. And we’re still scratching our heads, wondering why so many clinical trials fail to meet their endpoints? Researchers and regulators desperately need to start listening to people affected by health conditions, and working with them to develop meaningful outcome measures that will give clinical trials the best chance of success. At Parkinson’s UK we’re currently working with Parkinson’s Foundation and pharmaceutical company UCB to do just this, but we need to see more projects of this kind happening if we are to succeed in transforming the way clinical research is done.

Good communication is key when it comes to clinical trials

Another thing that struck me from Stacey’s talk, and something that came up in a number of other discussions throughout the conference, was the fact that clinical trials are seen as a last resort option for the majority of participants. Many turn to clinical trials only once all other treatment options have been exhausted.

There was a great panel discussion on the morning of day 2 which delved into some of the reasons for this, and other barriers to taking part in clinical trials. The panel included a trial participant, two research staff and someone who had not taken part in a clinical trial before, providing a range of viewpoints on the myths and realities of taking part in research.

The take home message from the panel discussion was that good communication is vital for encouraging patients and the public to take part in clinical trials. There remains a lack of awareness amongst the general public about research — many people don’t even know that taking part in a clinical trial is an option. The term ‘research’ often has negative connotations, and there is a perception amongst many that clinical trials are only for those who are very seriously ill. The panel spoke about the need to demystify research and highlight the wealth of benefits taking part in research offers to people. Sharing stories from those who have taken part in trials is a powerful way to spread the message about research — something we are passionate about at Parkinson’s UK.

It’s also important that researchers clearly communicate why the research is being done and what it involves. Patient information sheets are still often written in language that is inaccessible and unclear — research staff on the panel commented that they spent a lot of time going through information sheets with prospective participants, sometimes struggling to make sense of the information themselves. At a time when patient involvement is such a prominent topic in research, it is frustrating to hear that many researchers aren’t taking the opportunity to work with patients and the public to improve information sheets and consent forms — especially when this is arguably one of the easiest ways to involve people in research.

Embedding patient involvement — a new way of doing clinical trials

This is a sign that, despite some great progress in recent years, we still have a long way to go when it comes to truly embedding patient involvement throughout the research process. Ben Cromarty, who shared a model for patient involvement through Community Advisory Boards, made an important point that “patient centricity” does not equal patient involvement. Patient involvement is an ongoing process:

Ben also noted that whilst we know that involvement early on in the research process creates the biggest impact, in practice it is still mostly happening at the late phase — we have a way to go in improving this.

Lode Dewulf called for researchers to adopt a new approach to clinical trials — which he termed CO-trials:

  • COdesigned with patients and the public
  • COmpatible with life and practical for people to take part in
  • COmpassionate with participants
  • COmprehensive and well explained
  • COmorbidity aware
  • COntinuous, providing ongoing support and information to those involved

Summary

It was encouraging to see that from the start of the conference, patient involvement was a key theme throughout many of the discussions. The landscape is shifting — patient centricity is moving from just a company strapline to tangible actions that aim to put people at the heart of research.

There is much work still to be done. But as momentum for patient involvement continues to build, we have a unique opportunity to truly transform the way clinical trials are done, and improve research for everyone.


Patient and Public Involvement at Parkinson's UK

Keep up to date with the latest information from the…

Dr Natasha Ratcliffe

Written by

Research Involvement Manager at Parkinson’s UK

Patient and Public Involvement at Parkinson's UK

Keep up to date with the latest information from the Parkinson's UK patient and public involvement programme, and read about how involvement is shaping Parkinson's research.

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