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Case study: Translating intention into action - Piloting the NIHR Patient Engagement in Clinical Development Service

This service is available to all life sciences industries, including Clinical Research Organisations (CROs).

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Translating intention into action

In the UK the NIHR defines public involvement (also referred to as patient engagement) in research as “research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them.” It is a definition that we have become familiar with and the research community, including the life sciences industry, now accept that patient engagement should be a feature of any high quality research proposal.

There is also general agreement that well executed patient engagement activities can lead to better designed research, better recruitment and better retention. This is based on the simple principle that patients are the experts of their conditions; only they can truly tell us if we are achieving the right balance between the ‘ask’ of the research and the burden of the disease.

To achieve this balance it is crucial that patient engagement happens early in the clinical development process.
In October 2018 a small team based within the NIHR Clinical Research Network decided to embrace this concept and began developing the NIHR Patient Engagement in Clinical Development Service.

The primary aim of the service is to bring patients and life science companies together before a study protocol is finalised.  By focussing on facilitating patient engagement activities at this point in the clinical trial process it provides an opportunity for  patients to help make trial designs as patient-friendly as they can be.

The NIHR is in a unique position to be able to broker this relationship as a neutral, public sector organisation, working in close partnership with the NHS, with a long history and track record of supporting the life science industry to deliver clinical research in the NHS. Throughout 2018 and early 2019 we collaborated with patients, clinicians and a global pharmaceutical company, Pfizer Ltd, to design and pilot the new service.

The pilot involved two Pfizer studies looking at a new treatment for eczema which were both paediatric and adult studies. We 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, reflects on her experience of the pilot:

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

“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. Both studies are now open to recruitment.

“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.”

“Throughout Pfizer all studies now need to have some level of patient engagement into the protocol and study documents in order to achieve approval to proceed to execution. We are already planning to use the NIHR service again to help meet those requirements. We have several clinicians who are keen to learn more about the service and a number of studies in the pipeline that are suitable.”
“Other companies looking to engage with patient’s in the UK will certainly benefit from the work we have done and be able to quite quickly and efficiently engage with patients. I can’t image that we left any legal or compliance stone unturned, so I am reasonably confident that the service will fit their needs without having to do too many amendments to the service documentation.

The service model is now  being tested by a number of early-adopter companies and it has emerged that having our NIHR facilitators act as an independent ‘go-betweens’ 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:

“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. 

The NIHR is absolutely instrumental and fundamental to brokering that deal

“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 NIHR — 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 NIHR, patients and members of the public are more open to having those direct discussions with life sciences companies. The NIHR is absolutely instrumental and fundamental to brokering that deal.”

Videos: Company and patient perspectives

Pfizer's Sophie Evett talks about why it is important to engage patients before a study protocol is finalised. She also reveals how patient feedback was used to shape the protocol and the informed consent documentation for two Pfizer studies.

Research Patient Ambassador, Keith Wilson, is passionate about patient involvement. Watch a short video of Keith Wilson explaining the value that patients can bring to clinical trial design when working together with the life sciences industry and describing how important the NIHR's role, as an independent intermediary, is when engaging with NHS patients.

About the service

For the life sciences industry engaging directly with patients brings many challenges:

  • How do companies find patients/public to work with?
  • How do companies manage legal requirements, professional standards and commercial sensitivities?
  • Will patients/public have sufficient understanding of scientific and research language?
  • What formats should companies use to communicate with and work with patients/public to achieve respectful relationships?
  • How should patients/public be thanked and recompensed for their time, commitment and expertise?

The NIHR Patient Engagement in Clinical Development Service offers solutions and support to help address these issues. You can find out more and learn how the service works on the Patient Engagement in Clinical Development Service web page.