Published: 29 May 2019
Sophie Evett, Feasibility lead for Pfizer, highlights three observations while reflecting on her involvement in the NIHR’s Patient Engagement in Clinical Development pilot project.
I’ve been working closely with the NIHR on two pilot studies - which are both pediatric and adult studies - looking at a new treatment for atopic dermatitis (eczema). The NIHR helped us to identify and engage with patients to provide their views and opinions of certain aspects of these studies. Two facilitated meetings took place 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.
Following the engagement, the young people’s feedback was used to shape the informed consent and assent documents and, for the second study, one element of the draft protocol was amended which related to prohibiting other medications. In addition, the number of blood samples initially required from the patients was reduced - again as a direct result of engagement with the parents/carers.
The first study is now actively recruiting patients and parents/carers are being consented with the informed consent documents that were shaped by the young people at that meeting. The second study has since been approved to move to site-selection stage.
I’m pleased with the outcome, we achieved what we set out to do. Along the way we made a number of observations, here’s three which other life science companies might be interested to hear.
The patient voice
The Clinician who wrote the protocol met with both patient groups in person. 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 documents.
Blueprint for future engagement
Looking at the pilot more as a whole, 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 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.
Quicker and more efficient
Other companies looking to engage with patients 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.
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 NIHR Patient Engagement in Clinical Development service and a number of studies in the pipeline that are suitable including a Lupus study for which we already have a patient group that has expressed an interest in working with us – so watch out for more updates in the future.
- Find out more about the NIHR Patient Engagement in Clinical Development Service.