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Engaging patients earlier in clinical development

Successful patient engagement is essential to the clinical development process. How can companies get it right?

Patient and public engagement in clinical research means that research is done in collaboration with patients and the public, rather than ‘to them’ or ‘for them’. It is a definition that we have all become familiar with and the research community, including the life sciences industry, now unquestioningly accept that patient engagement should be a feature of any high quality research proposal.


There is also agreement that well executed patient engagement activities lead to better designed research and improved participant recruitment. Patients are the experts of their conditions; they are the only people who can truly tell us if we are achieving the right balance between the ‘ask’ of the research and the burden of the disease.


Last October, the National Institute for Health Research’s Clinical Research Network (CRN) announced a pilot project which aimed to address some of these challenges while focusing on facilitating patient and public engagement activities earlier in the clinical development process – specifically at the protocol finalisation stage.

Throughout 2018, we collaborated with patients and a global pharmaceutical company, Pfizer Ltd, to design and pilot this new service. The pilot involved two Pfizer studies looking at a new treatment for eczema which were both paediatric and adult studies. The CRN facilitated two meetings at Alder Hey Children’s Hospital NHS Foundation Trust, Liverpool, firstly with a group of young people  and then with a group of parents/carers.

Sophie Evett, Feasibility Lead for Pfizer UK, who led Pfizer’s participation in the pilot, said: “At the study level, the clinician who wrote the protocol met with both patient groups in person, as did my colleague who supports recruitment for Pfizer globally. They were surprised at some of the questions they were asked by the young people in particular. Some of the questions were very scientifically technical, for example around how the drug might alter your immune system and what effects that might have on the body. The young people were not afraid to say what they felt and were very clear about what they wanted to see included in the informed consent and assent document. For the adult study, one element of the draft protocol relating to prohibiting other medications was amended as a direct result of engagement with the parents/carers, and the study has since been approved to move to site selection stage.

“Looking at the pilot more broadly, it took a little longer than expected to satisfy our legal and compliance teams initially, mainly because it was a completely new way of working. However, it was a worthwhile exercise because it has enabled us to work through the many legal and compliance challenges and develop documentation that we can use time and time again for patient engagement activities, regardless of the study, patient group or therapeutic area.”


The model is currently being tested by a number of early-adopter companies and it has emerged that having the CRN act as an independent ‘go-between’ is an important factor in the pilot’s success. Keith Wilson, Patient Research Ambassador for Liverpool Heart and Chest Hospital NHS Foundation Trust, worked with CRN on developing the pilot. Keith explained: “The main challenge in the past has been around trust. Patients and the public have historically been wary of the life sciences industry, and some may still harbour some misconceptions.

“I thought the pilot was a great idea and long overdue but, at the same time, I was initially sceptical that the project would achieve the desired outcomes. However, having the CRN – which has worked in partnership with our NHS for over a decade – facilitate the service has made an enormous difference. Patients love their NHS, and if the approach comes from the CRN, patients and members of the public are more open to having those direct discussions with life sciences companies. The CRN is absolutely instrumental and fundamental to brokering that deal.”

The pilot continues and in the autumn we plan to publish case study material from our early adopter companies which will describe how this patient engagement process can have a positive impact on clinical trial design. The ambition is then to establish a national framework for earlier patient engagement by 2020, with the CRN providing a clear route for life sciences companies to connect with relevant patients to help ensure patient-friendly clinical trial designs.


Dr Matt Cooper is the Business Development and Marketing Director for the National Institute for Health Research’s Clinical Research Network.

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Matt Cooper
Matt Cooper
Dr Matt Cooper is the Business Development and Marketing Director for the National Institute for Health Research’s Clinical Research Network. Go to


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