The people-centred clinical research (PCCR) project has recently published hallmarks for good, people-centred, clinical research. The hallmarks cover how research teams should act and what people-centred research looks and feels like for people taking part.
By taking part, we mean being in a study as a participant. This is different to public involvement, which shapes how research happens. But of course, you can’t have good people-centred research without good public involvement: asking what matters most and working together in partnership.
Kate Greenwood, Senior Improvement Development Manager at the HRA, and Sarah Markham, a public member of the PCCR steering group, reflect on their experiences of collaborating to develop the hallmarks.
How has public involvement informed and influenced this work?
We knew early on that it wasn’t for the HRA to decide what good should look like. This is why we set up the people-centred clinical research steering group.
The steering group has been fundamental to shaping the whole project and how the hallmarks developed. It challenged our language and our assumptions and pushed us for more.
As a result, the hallmarks became something to be held by participants as well as researchers, to really express their perspective. We hope the hallmarks can help people start a conversation with research teams when they are asked to take part. We would not be thinking this way at all, if it were not for the group.
As a patient public involvement member, I have been stunned by the sheer commitment and flair with which Kate Greenwood and Barbara Molony-Oates (Public Involvement Manager) have set-up and guided the development of the hallmarks hand-in-hand with us, the members.
Their energy and dedication to genuine co-production has been remarkable. I hope the HRA knows how fortunate it is to have them.
What has gone well, and what hasn’t gone well?
I think one of the best things is how everyone has worked as constructively critical and respectful members of the hallmark creation team. The way people have helped and just how much they have contributed – both mentally and emotionally – should not be underestimated.
At the last meeting, someone said the group members trust each other, and this means they have been able to be honest in meetings and about the work.
At every meeting, we evidenced the group’s impact and shared all the changes made in response to their suggestions. I hope the group can see how they have made a difference.
We set out eight meetings at the beginning, but this was not enough. We were torn between ensuring the group had true ownership whilst not expecting people to give their time beyond what had been agreed. ‘Do what you say’ was always in the back of my mind, but also to listen and develop the work as a group.
In the end, we offered additional opportunities to review things by email and held optional drop-in meetings by Zoom. We know this isn’t ideal and have been lucky enough to have a small budget that has allowed us to do this. Not all projects have this flexibility, and everyone has been very understanding.
What have you learnt?
The hallmarks are a great checkpoint against which to judge your approach for many things that involve working together with people.
Good relationships are essential for good trusting partnerships, but they are not a given; they take time, support, and investment to develop.
I’ve also learned that even when I try to speak in plain English, I still use jargon.
But the main lesson I learnt is from a group member who very sadly died just before we launched the hallmarks. That is to be brave and to persevere. She said we need to knock on doors; to try and not be fearful. That if you do everything with a smile and act with kindness and respect, then honesty and trust can prevail.
I have learned so much from listening to other members’ contributions during meetings.
The thing I will remember most is an epic question which grounded everything: what is a clinical trial? Without having a sound and grounded understanding of what a clinical trial is, why they matter and what is involved in participation, the hallmarks would have not been as good as they are.
To read more the People Centred Clinical Research project, and to view and download the hallmarks with a simple infographic, please visit our website.