Dr Matt Westmore
Chief Executive, Health Research Authority
Patients must be involved in the design as well as participation of clinical trials to ensure they are relevant for the people they are created for.
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 approval of their clinical trial. We ask how researchers are working in partnership with people with relevant lived experience to inform how they design, carry out and share their study.
We ask this question because understanding how lived experience has shaped the design of a study is a core part of evaluating its ethical acceptability.
Ensuring the relevance of clinical trials
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. Fundamentally, this is just the right way to do research. It is about patient voice and patient power in health and social care and can ensure outcomes match people’s needs, reducing research waste.
But is it always possible? At the start of the COVID-19 pandemic just 22% of the first COVID-19 studies set up to learn more about the disease had involved patients whilst the research was being designed.
We ask this question because understanding how lived experience has shaped the design of a study is a core part of evaluating its ethical acceptability.
Improving recruitment and experience
We worked quickly with partners who shared our view that this needed to change. Our COVID-19 matching service linked researchers with public contributors who could provide feedback and input into COVID-19 research studies at speed before they came to us for approval.
Within six months, over 85% of COVID-19 studies were involving patients, helping to improve recruitment into trials and the experience of being a participant.
Embedding public involvement in research
Public involvement in the design and management of clinical trials is important, expected and possible, under even the most difficult circumstances. We achieved it during the pandemic, but how do we embed it in all research?
Clear and consistent leadership is needed to ensure patient involvement in all research studies all of the time and we can’t do it alone. Collaboration across the whole research system, supported by good communications and information, is needed to ensure that public involvement is ‘business as usual’ and at the heart of health and social care research, whatever the circumstances.
We have an ongoing commitment to support researchers to involve patients and the public in their work at the earliest opportunity. Watch this space!