Published: 15 May 2019
Gareth Powell talks to members of Generation-R (a Young People’s Advisory Group) about when and why young people should be involved in the clinical development process.
“Out of the mouths of babes...” is a biblical phrase that my Grandma’s generation used a lot. It's normally used when a young person says something that surprises you because it seems either very wise, completely obvious, or just brutally honest. We might not hear that phrase very often anymore but the underlying principle still applies, and when life science companies engage with YPAG - Young Person’s Advisory Group - this is really what they are seeking and relying on.
YPAG consists of five groups based in Liverpool, Birmingham, London, Bristol and Nottingham. They are all made up of 10-15 members who are aged between 8-19 and who are keen to help shape clinical research. Generation R is a Young Persons Advisory Group coordinated via Alder Hey Children's Hospital NHS foundation Trust, Liverpool, and last year this group made a valuable contribution to a project I am currently working on.
I’ve been leading the delivery of the NIHR’s new Patient Engagement in Clinical Research for a number of months now. The aim of the service, in a nutshell, is to bring patients and life science companies together earlier in the clinical development process, before a study protocol is finalised, so that patients can help companies to make commercial clinical research as patient-friendly as it can be.
Throughout 2018 we collaborated with patients and pharmaceutical company, Pfizer Ltd, to design and pilot this new service. The pilot involved two Pfizer studies looking at a new treatment for atopic dermatitis (eczema) which are both paediatric and adult studies. We, the NIHR, facilitated two meetings at Alder Hey Children's Hospital firstly with members from a Young Person’s Advisory Group (YPAG) which calls itself “Generation-R” and then with a group of parents/carers.
Sophie Evett, Feasibility Lead for Pfizer UK, who led Pfizer’s participation in the pilot, was quoted in a recent article saying:
“At the study level, the clinician who wrote the protocol met with both patient groups in person, as did my colleague who supports recruitment for Pfizer globally. They were surprised at some of the questions they were asked by the young people in particular. Some of the questions were very scientifically technical for example around how the drug might alter your immune system and what effects that might have on the body. The young people were not afraid to say what they felt and were very clear about what they wanted to see included in the informed consent and assent document."
Both the study design and the patient information were adapted as a result of this direct engagement with the patients. We are now developing the service further by working with a small number of early adopter companies to test the model. But, just going back to that quote, I recently asked the same group of young people for their thoughts on the new service and what we are trying to achieve. Here’s a summary of what they told me:
Understanding and insight
Generation-R members know that only a young person can truly provide a young person’s perspective, regardless of the condition being researched. One of the young people told me:
“I think often young people can think slightly differently to professionals and can provide alternative viewpoints and suggest fresh ideas. I also think when the research is regarding young people it is really important to involve a YPAG as they are young people themselves and therefore can provide a better understanding of how young people think.”
Another said:
“When young people are the heart of research trials sometimes it is easy to forget about their perspectives on treatment and how routines [of] treatment may affect their usual daily life.”
And then went on to say:
“Through involving the voices of young people in research, research trials are carried out as effectively and successfully as possible [because] the research is tailored to suit the situations of the young people.”
Which leads on to my second point...
Design and delivery
When the Generation-R members were asked what they thought about our idea of involving patients earlier in the clinical development process, they hit the nail on the head. One said:
“I think it is beneficial to include young people from the earliest stages possible as that way the whole process will have input from us. When a researcher comes right at the end it suggests we are just a ‘tick box’ and they don’t really care for our input. Also it means they have to backtrack their research which causes more work to be done, and sometimes it can be too late and the best process possible hasn’t been used.”
Another simply said:
“[Our] contributions are added at a stage where it isn’t too late to change.”
Finally, this one really says it as it should be:
“Just ensure that young people are involved at EVERY stage development.”
Impacts and outcomes
They also know that researchers need their help, and they are clear about the impact that they can have. They told me:
“Through involvement from the very beginning Generation R are able to suggest ideas for how to make the trial appeal and accessible to young people, which is an essential part of a clinical trial.”
And:
“Involving Generation R in the initial stages of research allows for our input to truly be implemented. It allows for our team to suggest and improve clinical trials from the outset, meaning as the trial progresses we continue to improve and help further the clinical trial.
My overall observation was how engaged these young people are with the idea of clinical research, including research designed, funded and delivered by the life sciences industry. This is reassuring because it means that the public perception is changing and people in the UK are beginning to better understand the important role that the life sciences industry plays in developing new medicines and treatments, not just for our NHS, but for patients all around the world.
- Find out more about the NIHR Patient Engagement in Clinical Development Service.
- Read a blog/watch a video of Dr William van’t Hoff explaining how a new NIHR service is bringing patients and the life sciences together to help achieve a balance between the ‘ask’ of research with the burden of disease.
- Read a blog/watch a short video of Keith Wilson, Patient Research Ambassador, explaining the value that patients can bring to clinical trial design when working together with the life sciences industry and describing how important the NIHR's role, as an independent intermediary, is when engaging with NHS patients.