Shape the design of a Familial Hypercholesterolemia clinical trial

Shape the design of a Familial Hypercholesterolemia clinical trial

NIHR Patient Engagement in Clinical Development Service:

Are you interested in research? Then this opportunity to shape the design of a Familial Hypercholesterolemia clinical trial is for you!

The National Institute for Health and Care Research is pleased to share an opportunity to be involved in the co-design of a commercial trial (that is a trial funded by a pharmaceutical, biotechnology or medical device company) in Familial Hypercholesterolemia, and participate in an insight session.

By sharing your experiences of living with this condition, we want to ensure that this and future trials are designed with patients and for patients. We want to make trials as accessible as possible for everyone.

Am I eligible to participate?
The NIHR is looking for 6 adult individuals, over 18, to participate in thisopportunity. We’re looking for individuals who have been diagnosed with familial hypercholesterolemia (FH), or who have a family history of high cholesterol, premature cardiovascular disease and have experienced high cholesterol levels and/or cardiovascular events like a stroke or heart attack themselves. You will need to be comfortable with discussing your experiences with other online through Zoom. Prescribing clinicians are not permitted to participate for regulatory reasons. If you are a prescribing clinician and are unsure please get in touch to discuss this.

What do I have to do?
Our intention is to host a facilitated online session, to discuss the management of these conditions and to comment upon the design of a clinical trial. We’re hoping to learn how individuals manage their condition, how we may be able to address potential issues to improve the quality of life for this condition and how we can ensure these trials are designed in such a way that they are as accessible as possible. You will be asked to dial into an online video conference platform such as Zoom at a time agreed with all participants. Timings can be flexible, such as evening or late afternoon hours to allow for working hours. These meetings will be chaired and led by an NIHR facilitator and everyone will be given an opportunity to speak on a range of topics and share their insights.

Who is leading the discussion?
The meetings will be chaired by an NIHR Facilitator, however, we will also have representation from the life science company on the call who have designed the clinical trial to answer any queries you may have about the trial.

Will I get paid?
The NIHR, on behalf of the life science company, will reimburse you £100 for your participation. Please review information about payment and tax and national insurance.

What’s the NIHR Patient Engagement in Clinical Development Service?
The NIHR Patient Engagement in Clinical Development Service is designed to enable the Life Science Industry to engage with individuals such as yourself, to ensure that trials can be co-designed with individuals most likely to be impacted by them, to ensure that the objectives of the trial align with those of the patient community and that these are as easy to join and complete as they can possibly

You can find out more about this service at the following:
Information Sheet for Patients NIHR Patient Engagement in Clinical Development Service – Home Page

Are these commercial trials? What does this mean? Will they be able to access my information?
These are clinical trials created by and funded by a commercial sponsor (the company). They will be hoping to deliver these clinical trials with the NHS. As the information at this stage is sensitive we can’t share with you the company name but if you agree to participate we will be able to share this with you. As the service is being facilitated by the NIHR we will not be sharing your details
with the company, this will be managed by the NIHR. You can find additional information about this in the Information Sheet for

What Information will the NIHR need about me?
To ensure we’re engaging with as diverse a demographic of people as possible we’d ask you to share with us your name, age, experiences of your condition (either as a patient or a carer), if you’ve participated in clinical trials previously or similar initiatives.

What happens afterward?
You will be reimbursed following the insight session I’d like to be involved, how do I find out more? If you’d like to register your interest in participating in this opportunity or simply if you have any questions in relation to this please contact by the 6th October 2023

Isabella Darbyshire
PECD Service Coordinator