Published: 27 January 2021
The NIHR Patient Engagement in Clinical Development Service connects life science companies with patients who want to help shape and improve the design and, ultimately, the delivery of commercial clinical research. It is available to all life sciences industries, including Clinical Research Organisations (CROs).
Being agile and able to adapt to the new normal is crucial during the COVID-19 pandemic. By switching to a virtual model of patient engagement activities, the NIHR successfully supported Pfizer to gather patient input from psoriasis patients on a proposed trial of a new treatment. The virtual sessions had excellent feedback and also enabled participants to contribute from the comfort of their own homes.
Direct dialogue with patients
The study being proposed by Pfizer was a phase II trial for a new immunomodulating topical treatment for psoriasis. Psoriasis is a chronic skin condition that causes dry, flaky, itchy patches of skin to build up. It is associated with an immune response that is characterised by an excess production of skin cells. There is no cure for psoriasis but patients have different treatments and coping techniques to manage their symptoms.
To gain patient input, Pfizer accessed the NIHR Patient Engagement in Clinical Development Service to deliver two patient insight sessions, similar to focus groups, and to identify and engage suitable patient participants. These sessions are an opportunity for researchers and the team at Pfizer to speak directly with patients and gain their insight on different aspects of the proposed new trial. The NIHR, also present at the sessions, acts as an independent intermediary between researchers and patients, encouraging open and honest dialogue between both parties. Sophie, Feasibility Lead at Pfizer, highlighted that her colleagues who design clinical trials “really appreciate that direct dialogue and really get an understanding of what it’s like to live with a particular condition, [...] that’s a bit unique about this service.”
“The NIHR patient engagement service means you have a direct connection with those individuals who are actually writing the clinical trial and those patients living with the condition who know the condition best.”
Sophie Evett, Feasibility Lead at Pfizer UK
The psoriasis patient insight sessions were held in August and September 2020 during the COVID-19 pandemic. To ensure the safety of all contributors, the sessions were conducted virtually, rather than in person. This meant that it was easier for Pfizer colleagues from the US to join. Researchers also found that participants preferred the virtual format of the sessions as it meant that they could engage with the study from the comfort of their own homes.
During the patient insight sessions, participants were asked to input on the design of the proposed phase II trial. They provided feedback on things like the planned duration of the trial, whether they would be willing to stop taking their current medications in order to participate, and if they preferred a topical treatment, oral therapy or injection. The participants also indicated their interests in joining a trial and provided insight on where they would look to join, suggesting that they would search online but would also consider joining if approached by a doctor.
The sessions generated valuable insight directly from the patient participants, which is now being considered in the design and development of the phase II trial. In addition to answering the questions put to them, the patients also provided feedback on how the trial would affect them in ways the researchers had not imagined. Sophie noted, “a lot of the most valuable insights haven’t been from the questions we’ve asked, they’ve just been from what the patients have told us.” This feedback will potentially impact a number of aspects of the design and delivery of the trial from small details to significant logistical changes. Designers of the trial are now considering a range of changes to the protocol including enlarging the font size of the drug insert leaflet, making it easier to read.
Impact: Adapting delivery to meet patient needs
The impact of the patient insight sessions has been particularly salient in relation to the recent lockdown restrictions and the COVID-19 pandemic. Patients raised concerns about how the pandemic would affect the trial with a mixture of feelings among the group. As a result, the designers of the trial are discussing how to adapt the delivery of the trial to suit the patients’ needs. They are considering how treatments would be delivered in a clinical setting, home health visits and the possibility of virtual or telemedicine sessions.
Clara, a participant of the recent patient insight sessions with Pfizer, has been actively involved in clinical research since 2016, providing insight on a number of trial designs through the NIHR and other institutions. She has become what is known as a patient expert, with extensive experience in advising on research projects from a patient perspective. She is passionate about research and, like many other patients who engage in these sessions, is keen to contribute towards future trials or medicines for others who also live with psoriasis.
“It helped me acquire an insight into new potential drugs for what’s a chronic disease but also the feeling of being heard and knowing that all our voices can lead to an improvement in that particular clinical trial design.”
Clara, psoriasis patient involved in the recent patient insight session with Pfizer.
In creating the Patient Engagement in Clinical Development service, the NIHR collaborated closely with Pfizer, patient representatives, clinicians and the Association of the British Pharmaceutical Industry (ABPI) to design and deliver the pilot of the scheme. Over the course of a year, together they developed a ‘Letter of Agreement’ which is a key feature of the service, helping to alleviate many legal and compliance challenges associated with directly engaging and involving patients. Sophie is enthusiastic about future trials utilising this important resource. “Now we have that it’s great because we have something in place we can just use it again and again with each individual trial.”
In addition to the ‘Letter of Agreement’, the NIHR operates a standardised national pricing model for each type of patient engagement activity. This alleviates some of the challenges faced by companies wishing to gain patient engagement, as the NIHR has a standard practice for reimbursing participants for their time and expertise. This ensures that participants are offered fair market value for their insights and means there is no conflict of interest for companies operating the engagement sessions.
So far, Pfizer has utilised theNIHR’s Patient Engagement in Clinical Development service for eight protocol designs. As a result of the extensive collaborative effort in developing a pragmatic and reliable service, Pfizer is hoping to work with theNIHR on patient engagement activities for a number of future trials. Every session Pfizer has been involved in so far has resulted in some change or impact to either the clinical development process or associated clinical trial documentation. Sophie noted, “every engagement has led to something, even if it has been a small change being advised. So that’s the whole point of why we do it - it’s great.”
Learn more about the NIHR Patient Engagement in Clinical Development Service.