In February 2023, the government announced an independent review, led by Lord James O’Shaughnessy, into the UK commercial clinical trials landscape. The review aimed to support the life sciences sector to unlock UK growth and investment opportunities, and suggested solutions to the key challenges that are faced when carrying out commercial clinical trials in the UK.
The review recommended establishing a common approach to contacting patients to take part in research and set out how researchers can access data in a way that people can trust when identifying who to contact to take part in a study. The HRA was asked to lead this work on behalf of the Recovery, Resilience and Growth programme partners. This was a very short piece of work with a focus on identifying further potential actions for the partners to take forward.
The aim was to recommend:
- opportunities to streamline how patients are approached about research
- how the public should be consulted
- whether legislation is needed to clarify the use of patient information for identifying and contacting people about research.
The HRA set up a small UK-wide project group, which included public contributors, to oversee this work. Kelly Rowe, HRA Approvals Manager, and Chris, a public contributor who was part of the group, reflect on how they worked together.
How has public involvement informed and influenced this work?
KellyAs this work looks at how patients are approached about research, it was key that the public were included in the discussions. Those of us at the HRA and our UK wide partners can provide guidance on the legislative aspects. Our public contributors, Marie-Clare and Chris, gave a patient perspective on what it’s like to be contacted about research. They also shared any concerns they have, particularly in relation to commercial research.
ChrisWe joined a small group with a specific instruction and fixed timeline. The scope and output (a report) had already been defined. Within this, we had windows of opportunity and influence and we were able to:
- comment on and make suggestions on the working documents
- bring public perspectives into the discussion
- recommend using less jargon and more plain language
- note that patient groups and community groups are also important stakeholders
- highlight the importance of patient and public involvement and engagement in research, and the added value in this work
What’s gone well, and what hasn’t gone well?
ChrisWhat went well? We were:
- equal members of the working group
- supported by the HRA team to fulfil the role of public contributor
There was:
- recognition of the effort and time invested in familiarising ourselves with a complex theme
- recognition of the input given. The team were always open and responsive to points, including critical points, and acted upon them at a later stage
- efficient time management and excellent chairing of our meetings and the report was delivered on time
What could be better? There could be:
- wider representation of members of the public, including patient representatives, from all four nations
- a less rigid timeline to think about such a large theme and bring together different views from different people into one report
- more involvement for members of the public, with a say on the agenda items, writing the recommendations, and communication plans
KellyIt was so valuable to have two public contributors who provide a wealth of opinion and guidance. Marie Clare and Chris have helped us to take stock, revisit how we present this report to the public, and make sure we have considered other ways it could be presented, as not everyone wants to or is able to read a full report!
The tight timeline and potential scope of this project meant project board meetings had to be very focussed. We couldn’t always give as much time as we wanted to review documents before meetings. But Marie Clare and Chris were able to work around this and provide feedback outside of meetings if necessary.
What have you learnt?
ChrisOverall, this has been a positive involvement opportunity for me. Although it was challenging to review working documents written in a highly technical language and keep up with the pace of this work, I felt well supported and valued as a member of the group. I was encouraged to raise issues important to patients and members of the wider public with respect to their health and care data, and share concerns from this point of view.
KellyThis project group learnt that we only really touched on the tip of the iceberg in relation to patients and the processes for how they can be contacted about research. Further recommendations have been made to ensure that public discussion and awareness happens.