Patient Engagement in Clinical Development Project
INFORMATION SHEET FOR PATIENTS
Version 3.0 – 01 November 2023
About the Service
What is the NIHR Patient Engagement in Clinical Development Service?
This video provides an overview of how our Patient Engagement in Clinical Development service works (fewer than 4 minutes). Further detail is provided below.
The Patient Engagement in Clinical Development Service creates opportunities for patients and the public to contribute to the design process of company-led clinical trials.
Patient insight into clinical trial design brings a wealth of benefits. It provides protocol writers with a unique insight into living with the condition of study, highlighting points that may not have previously been considered and helping to identify areas of an excess burden that may be off-putting or restrictive for participation in the trial.
Why should I participate in the Patient Engagement in Clinical Development Service?
This is an exciting opportunity to be involved in the design of a company-led clinical trial. By contributing to the service you will be helping to improve the delivery and accessibility of clinical trials, potentially leading to better health outcomes for all.
What would I be expected to do if I did participate?
The Patient Engagement in Clinical Development Service supports companies in a number of different ways to ensure the patient voice is heard during the trial design process.
For example, you may be asked to review a Patient Information Sheet, or take part in an online insight session where you will talk about your experiences of living with a condition and consider whether the demands of a proposed trial protocol would be achievable.
Topics often discussed when reviewing a trial design include:
- The number of study visits required and how viable this in the balance of day to day living
- Potential procedures that may need to be carried out, and whether the length and duration of these are realistic
- If the burden placed on a participant would simply be too much and if a solution is required to resolve this
By sharing your own experiences and insight you can help identify and resolve these issues prior to a study opening to recruitment. This will make it easier for others to enroll and complete the trial.
Do I need experience of clinical trials to participate?
You do not need experience of clinical trials or to have been involved in similar activities previously to register your interest in participation.
Often, and where possible, we will try and gather a range of experiences and opinions from a diverse group including age, gender and trial experience. Providing a range of experiences and opinions helps us to better represent the patient population the trial is hoping to enroll.
All participants contributing will have unique experiences. Everyone’s opinion is both valid and welcome.
How to participate in the Service
How do I find suitable activities to participate in?
There are a number of different ways through which you may see an opportunity advertised:
- Membership of a patient organisation (often via social media or direct outreach)
- Advertised on the NIHR ‘People in Research' website
- Advertised via the NIHR Be Part of Research Twitter feed
- Outreach via local NIHR Patient and Public Involvement Teams
Where will these meetings take place?
The majority of our insight sessions take place online, using the video conferencing tool Zoom. Where a session is planned to take place face-to-face, we will try to deliver it in a location which is convenient for all parties. We will also work to ensure it is at an independent venue, such as an NIHR office space.
If the opportunity is to review a document, we ask you to complete this task independently and then send us your feedback and comments via email or through a feedback form.
Expenses and reimbursement
What will I be reimbursed for?
The NIHR Clinical Research Network will reimburse you directly for your involvement in any meetings or activities as part of this Service. This will consist of:
- Payment for your time
- Any expenses incurred
We’ll reimburse you directly into your bank account, though please note that this can take up to 8 to 12 weeks.
You are required to notify HM Revenue and Customs local office of fees received only if your annual income exceeds your personal income tax allowance at the end of the financial year. You are responsible for calculating whether you need to pay any tax or National Insurance. The NIHR provides guidance on Tax and National Insurance.
How much will I be reimbursed?
The NIHR Clinical Research Network will use the payment structure set out in the Policy on payment of fees and expenses for members of the public actively involved as a standard guide to calculate and agree on any costs.
You are not obliged to fulfill any activities and are free to withdraw at any time. You will not be charged or invoiced if you decide to withdraw at any time. If you have incurred any costs and then subsequently decide to withdraw, we will reimburse you for these.
What happens afterward?
Do I get to see the results?
On the conclusion of the activity, we actively encourag our life science partners to share the results of the session. This may include what amendments have been made to a document or study protocol as a result of your insights and suggestions.
Likewise, if you have raised concerns or suggestions, and the company has been unable to make these suggested changes, we have asked them to let you know why this is e.g. it may be down to scientific or regulatory reasons.
Feedback and continuous improvement
After the activity has been completed, we’ll approach you to provide your feedback on the activity. It’s our intention to ensure that this is an interesting and enjoyable experience and we want to understand what we’ve done well and. equally, what we can do better in the future to improve this process.
Your feedback is optional but would be greatly appreciated and is captured using an online form which will be sent to you.
Hopefully, you enjoyed the opportunity and would like to be involved again. If you are interested in future opportunities, we can add you to our contact database and let you know if another suitable opportunity comes up.
You may also be interested in other Patient and Public Involvement opportunities which can be found at the Patients, carers and the public section of the NIHR website.
How will we keep your information secure?
Will any of my information be shared with the Life Sciences Company?
Throughout the process, we will ensure your details are kept anonymous from the company with whom we’re partnering to deliver the opportunity.
You may be asked to share some personal information, such as your gender, age, ethnicity or trial experience but your identity will not be shared.
During an insight session, it is up to you how much information you wish to share with the company, however, only information relevant to the activity will be recorded.
What type of information will be shared with the NIHR Clinical Research Network?
In the event you would like to participate and match the eligibility criteria, the NIHR Facilitator will request for your consent for the following information to be shared with the NIHR Clinical Research Network:
- Your name
- Your email address (if available)
- Your telephone number (if available)
- Demographic data (such as age, sex, gender or ethnicity so that we can ensure we have a representative mix of participants)
- Brief details of your health status or caring responsibilities
- Your address, bank account details and national insurance number (so that we can reimburse you for your time and expenses)
Who at the NIHR Clinical Research Network will be able to see my information, and will this be shared further?
Only approved members of staff based at the NIHR Clinical Research Network and University of Leeds (our host organisation) will be able to access your information. We will not pass on any of your personal information to the life sciences company or any other third party organisation.
We will work with the life sciences organisation to review the expressions of interest received for each opportunity, to ensure that people invited to the activity meet the requirements of the company. All data discussed with the life sciences organisation will be completely anonymous. When we provide the company with a summary report of the activity, we may give them
grouped demographic data on the participants. This will not be linked to your responses in any way.
Feedback, questions and complaints
What do I do if I no longer want to participate in the service, or want you to delete my data?
If you cannot, or simply no longer wish to participate in an activity, please let the NIHR Facilitator know - this will not impact on your ability to participate in future activities, nor will you be charged for any expenses incurred. Please email firstname.lastname@example.org with any requests to withdraw from an activity or our contact database.
How will questions, complaints and problems be managed?
We are always seeking feedback. Please email us at email@example.com.
How will the NIHR Clinical Research Network charge a Life Sciences Organisation for patient participation?
The NIHR Clinical Research Network Patient Engagement in Clinical Development Service is a cost recovery service. As such, the we will charge the Life Sciences Organisation for the activity for costs incurred (such as participant reimbursement costs) and a 20% sustainability charge to ensure we can continue to offer this Service and facilitate these opportunities.
The NIHR Clinical Research Network is a non-profit organisation hosted by the University of Leeds funded by the Department of Health and Social Care.
Terms of Service
Will any information related to this service be published?
Both the NIHR Clinical Research Network and the company may disclose or publish the nature and terms of this agreement for any legitimate purpose, including the disclosure of payments to healthcare professionals and organisations. Your personal information will not be shared as part of this.
How will personal data be managed?
The NIHR Clinical Research Network shall comply with its obligations under the applicable data protection laws. The NIHR Clinical Research Network will not share the personal data of participants with the company.
Your personal information is held and used in compliance with the General Data Protection Regulation (GDPR) as defined in the Data Protection Act 2018. The Department of Health and Social Care (DHSC) is the Data Controller under the provisions of the Regulation. Under GDPR, we have a legal duty to protect any information we collect from you and DHSC is committed to protecting privacy and to processing all personal information in a manner that meets the requirements of the Regulation. We will not pass your details to any third party or government department unless you give us your explicit consent to do so.
Get in touch
We value your views. If you would like to provide feedback or have any comments or questions about the service, please email firstname.lastname@example.org.
Return to the Patient Engagement in Clinical Development Service page.