National Institute for Health Research (NIHR)

Patient Engagement Project Lead

What is your role at the NIHR?
I lead the NIHR’s Patient Engagement in Clinical Development Service; an initiative that has been designed to facilitate relationships between life sciences companies and patients during the trial design stage. We support companies to overcome the challenges associated with engaging patients. These challenges can lead to inertia, but by working in collaboration we can convert good intentions into action.

Why is it important for patients to have a say in clinical research?
It goes beyond important, it’s vital. Two major challenges for companies, outside of increasing complexity and cost, are patient recruitment and retention. We often make assumptions about the factors that influence trial participation – such as the number and length of site visits. However, there are often a multitude of factors at play. Many are not considered simply because we haven’t engaged with those expected to undertake the trial. By working with patients, we can address these issues and ensure the trial is accessible, appealing and manageable. Patients are experts in their own conditions, only they can help us to balance the ‘ask’ of research with the burden of disease.

Is improving the quality of patient-centricity in research a core focus for the NIHR?
Patients have always been at the heart of the NIHR. We have a fantastic track record for patient engagement and involvement, from increasing the number of opportunities for participation to sharing the findings of trials. Continually aspiring to find new ways to embed the patient voice in our work, we have delivered a wide variety of initiatives over the years. A current major focus is around patient-centricity in commercial clinical research. Our experience tells us that we can make the biggest impact at the trial design stage – this was the rationale for the Patient Engagement in Clinical Development Service.

What are the key barriers to patient engagement in UK trials?
Previously it was ‘how’? One of the major challenges for companies was interpreting and understanding the regulatory environment. The ABPI code of conduct for patient involvement was criticised as being opaque and difficult to interpret. This has since been rewritten and additional good practice guidance is being provided by the HRA. So now the main challenge is ‘who’? This is where we come in. By reaching out through our national network we utilise existing relationships to identify and engage the intended trial participants (or representatives), then we facilitate introductions. Next it’s ‘where and when’? We provide a safe, neutral environment for companies to connect with patients, under our facilitation. Likewise, we can also manage the handling of patient data and reimbursement, which can also be a major stumbling block for companies.

Have you seen any changes in the life sciences industry’s approach to patient engagement in recent years?
The patient engagement conversation has certainly evolved from ‘why’ to ‘how’ with a number of companies now sharing good practice. But there’s still a long way to go, specifically in demonstrating ‘return on investment’. Finally, the COVID-19 pandemic has brought into focus the progress of Virtual Clinical Trials. Viewed by some as a ‘magic bullet’ for resolving many of the issues associated with patient participation, it’s important we don’t lose focus on why this way of working has emerged. We must continue to shape trial design, virtual or otherwise, together with patients.