Patient Engagement in Clinical Development Service
Information sheet for life sciences organisation
Version 2.0 – 29 January 2024
In this digital guidance document you will find further information about the NIHR Patient Engagement in Clinical Development Service and answers to the frequently asked questions.
For more general information about how the service helps life science companies to connect and collaborate with patients and the public to design patient-friendly clinical studies visit the Patient Engagement in Clinical Development Service page.
This is just one of the ways we work with life science organisations to help you to plan and conduct research in the UK. Visit our NIHR support for the life sciences industry page to discover our full range of support.
What is the aim of the Patient Engagement in Clinical Development service?
The primary aim of the Patient Engagement in Clinical Development service is to bring patients and life science companies together early in the clinical development process so that patients and the public can help companies to optimise the trial design by making it as participant-friendly as it can be.
We also aim to:
- Aid the life science industry in overcoming common challenges when involving patients and the public in research protocol design
- Foster positive relationships between the life sciences industry, NIHR, and the public
- Embed a culture of integration of the public voice from the outset of clinical development and throughout the study life cycle
- Establish a national, standardised mechanism for engaging the public and patients in the trial design stage of the clinical development process.
How does the service work?
For general information about how the service works and the types of engagement activities we can facilitate, read the Patient Engagement in Clinical Development Service page.
Who can use the service?
The service is available to all commercial sponsors of research across all life sciences industries (pharmaceutical, biotech, medtech) and Contract Research Organisations (CROs) contracted to plan and deliver commercially sponsored research.
Who is the service provided by?
This service is provided by the NIHR Clinical Research Network.
Is it patient-centric, patient-centred or people-focussed clinical research?
Different terminology is favoured in different industries and different countries.
In the UK, when we talk about the activities that are undertaken to achieve patient-centric, patient-centred or people-focussed clinical trials, we tend to use the terms patient and public involvement or patient and public engagement in clinical research. The research could be funded by the life sciences industry, charities or government.
The NIHR defines patient and public involvement in research as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them.
We recognise that patient-centricity and patient-centric clinical trials seem to be the most commonly used terminology throughout the life sciences industry.
My study protocol has already been finalised, can I still access the service?
The service is designed for studies which are in the early stages of clinical development as this is where public involvement can have the most impact. However, we can still support companies at later stages of the research design cycle, such as engaging members of the public to review participant-facing materials.
How do I submit a request for the Patient Engagement in Clinical Development service?
To access the service, simply complete our online service request form. We will review the submission and let you know if we need any further information within 5 business days. Once the service is underway we will liaise with you directly to keep you informed of our progress.
What information do I need to provide to use the service?
Contact details
We will collect contact information including: your name; the company you work for; telephone and email. These contact details are essential for us to deliver the service and you will be asked to agree to us storing your details for this purpose as required in compliance with the General Data Protection Regulation (GDPR) as defined in the Data Protection Act 2018.
Study details
To deliver the service we will need information about your study and about the ‘ask’ that will be made of participants, this includes:
- Description of the study. (If you have a lay summary, it would be useful to include this.)
- How and why you would like to engage with the public in your study design
- A description of the type of patient or public representative you would like to undertake the engagement activity, e.g, lived experience of a specific condition, disease stage, taking a particular medication, specific age range. Please also include any key exclusion criteria which may prevent a participant from supporting this request.
Who will be able to see my contact information and will this be shared?
Once you have submitted your information using our online service request form, only approved members of the Patient Engagement in Clinical Development service team, based at the NIHR Clinical Research Network, will be able to access your information. Your contact information will be stored in a secure SharePoint folder and hosted by the University of Leeds.
We will not share your study information when searching for participants matching your request. Participants will only learn of your company name or receive any study information after they have signed a consent form which includes confidentiality agreements.
Who will be able to see information about the study and will this be shared?
Approved members of the Patient Engagement in Clinical Development service team will review the information you provide on the service submission form to undertake an initial feasibility check of your request. We will then arrange a call with you further to discuss your request. All the information shared will be kept secure and can only be accessed by members of the service Team.
We will prepare an advertisement for members of the public to express an interest in joining the activity. This will be sent to you for review before it is published and will include:
- The therapeutic area/target population for the activity
- An overview of the ‘ask’ of participants in this activity
- An indication of when the activity will take place
Your company name, or any details of the proposed study, will only be shared with participants at the point of consenting to be involved. At this point, participants will sign a Participant Notification Letter, which includes a confidentiality agreement.
We will also ensure that an institutional Confidential Disclosure Agreement is in place between your company and the NIHR Clinical Research Network, if required, before any commercially sensitive documents are shared.
How do you identify suitable participants?
We use our national network, which covers the whole of England, and connections to other research organisations and charities to identify suitable participants. The time line for this part of the process varies. You'll receive regular updates from your assigned NIHR facilitator. Our best endeavours will be made to identify suitable patient groups, however we cannot guarantee engagement on behalf of patients or the public.
Is this free to register my study?
There is no charge for you to register your study for the service.
How much does the Patient Engagement in Clinical Development service cost?
The Patient Engagement in Clinical Development Service is an optional ‘paid for’ extension of the NIHR Study Support Service provided by the NIHR Clinical Research Network. The cost varies depending on the activities requested and number of participants. The service uses a transparent and fair full cost recovery model (see next question). Please get in touch to discuss your requirements and potential costs.
If participants have been matched, what is the remuneration package the NIHR Clinical Research Network is offering to individuals for participation, and how will I be charged for this?
The costing model is based on:
- Patient costs, which include remuneration, and travel and subsistence (where appropriate). We use the NIHR guidance document: Payment guidance for researchers and professionals to calculate these costs.
- NIHR Clinical Research Network Facilitator costs of identifying participants and facilitating the patient engagement activities. This is based on a fixed rate.
- Where appropriate: consumables - this can include venue hire, catering (as appropriate) and any travel expenses and other consumables.
- Sustainability charge - this is a percentage charge for the NIHR Clinical Research Network to re-invest in continuing, developing and expanding the service capacity.
The Letter of Agreement template has been authored in line with the Association of the British Pharmaceutical Industry's (ABPI) and we will work with you to ensure that all compliance and regulatory guidelines are followed.
At what point will I be charged for the use of the Service?
Once you register your study for the service, we will draft a 'Letter of Agreement' outlining the proposed activity and our team will start work to identify individuals to fulfil your patient engagement request. You will not be charged until the agreed activity has taken place. You can withdraw from the service at any stage before this point without charge.
How do I withdraw if I no longer want to use the service?
If you would like to withdraw from the service, please email pecd@nihr.ac.uk
How will questions, complaints and problems be managed?
If you would like to provide feedback or ask a question, please email pecd@nihr.ac.uk
Return to the Patient Engagement in Clinical Development Service page.