Leni Sivey, Public Involvement Manager, blogs about a pilot project launched by the Medicines and Healthcare products Regulatory Agency (MHRA) that puts patient involvement at the heart of clinical trials and medicine development.
Leni Sivey, Public Involvement Manager
It’s wonderful to hear about the MHRA’s upcoming pilot to collect information about the extent and impact of patient engagement in medicines development; I’m sure I’m not the only person who will be eager to hear about what the pilot finds out.
At the Health Research Authority, we ask researchers to tell us about the patient and public involvement in their research when they apply to us for regulatory approvals. We ask how researchers are working in partnership with people with relevant lived experience to inform how they design, carry out, and share their research.
We ask this about every single application that comes to us for review by our research ethics service, because understanding how lived experience has shaped the design of a study is a core part of evaluating its ethical acceptability.
Effective public involvement is one of the most practical ways to ensure that research will be relevant and important to the people it’s ultimately for – and that it will be acceptable and make sense to them.
'Supposing is good, but finding out is better.' - Mark Twain
Research is all about having an assumption and then testing out whether it’s true or not. Planning research means making assumptions about what will work well for research participants and the people the research is intended to benefit. Public involvement helps give researchers a much better chance of finding out whether those assumptions are correct; without it, those assumptions go untested.
Making assumptions about how research participants, patients, carers, service users, and other members of the public will think and feel about research without working with people who are experts through having relevant lived experience misses the opportunity to find out whether those assumptions are correct.
Despite this, we know that public involvement is still seen by many sponsors as something that’s ‘nice to have’ rather than a core building block of high quality research.
At the start of the pandemic last year we saw from monitoring what researchers were telling us in their applications for research ethics review that public involvement in research declined dramatically. In response we established the UK COVID-19 public involvement matching service to connect up research teams with a network of patient and public involvement groups ready and able to provide input into their plans.
One of the most striking things we learned through running the matching service was the acute importance of collaboration across the health and social care research landscape in order to develop a shared understanding that public involvement is important, expected, and possible.
We know that for public involvement to be meaningful it needs to be part of the research development process right from the start, and so we very much welcome MHRA taking this initiative to find out more about public involvement from the earliest stages of medicines development onwards. I’m looking forward to finding out what this work learns, where it leads, and how we can work together as regulators to put diverse, effective, transparent public involvement right at the heart of all health and social care research in the UK.