Engage with patients to improve your clinical trial design

Why engage patients in the clinical research process?

Patients are experts in their conditions. They are the only people who can truly tell us if we are achieving the right balance between the ‘ask’ of the research, and the burden of living with a condition or disease.

As well as gaining a better understanding of the patient’s needs, engaging with patients also has the potential to significantly improve study design and delivery. The earlier you engage, the greater the scope for improvement.

We believe that patients can and should be involved right from the beginning of the clinical development process, ideally before a protocol is finalised. This creates opportunities for protocols to be considered in real life scenarios (protocol simulations), issues to be identified, and problems to be resolved, and all before a study opens for recruitment.

See the impact of translating patient insight into action

Some of the benefits that are commonly reported as a result of acquiring and responding to patient insight include:

• Better study design
• Better participant recruitment
• Better participant retention
• Better protocol adherence.

Involving patients earlier in the clinical research process in a meaningful way requires investing a little time and resources upfront, at the trial planning stage. It can also sometimes present or uncover unexpected challenges. But when done well, your investment will pay dividends, and may even shorten your overall research timeline by preventing delays further down the line.

That’s why we have designed this service - specifically for life science organisations and Clinical Research Organisations (CROs) - to support all your patient engagement needs. Helping you to “get it right the first time”, to quote one of our patient research ambassadors.

Here are some more reasons you may want to choose the NIHR as patient engagement partner:

• National reach to find patients to advise on your clinical trial
  We use our extensive network, which covers the whole of England across multiple therapeutic areas, to engage relevant patients and groups
• Benefit from our brand and build better relationships
  Charities and patients engage with the trusted brands of the NIHR and the NHS. We act as an independent intermediary to broker and develop relationships on your behalf
• Achieve equity
  We’ll provide guidance on the application of nationally accepted remuneration for patient involvement activities and UK standards for public involvement in research
• Continuous support, bespoke to you
  Every study is unique and our support will be tailored to your individual requirements, every step of the way
• Supported by the ABPI
  This service is aligned with the ABPIs Code of Conduct.

Experience our patient insight sessions

Wondering how to engage patients in your trial design? We can arrange and facilitate group patient insight sessions. Both in-person and virtually (online). We can also coordinate remote activities where patients complete tasks independently. Typical patient engagement activities that we regularly support include:

• Identifying research priorities
• Reviewing study protocols
• Simulating the study delivery approach
• Supporting the development of, and acquiring feedback on, patient information sheets and related materials
• Acquiring feedback on participant recruitment and outreach strategies.

Confidently collaborate with patients

Our service has been specifically designed to help the life sciences industry engage in direct dialogue with your target patient group so that you can confidently:

• meet growing regulatory and requirements
• comply with industry-wide codes of conduct
• work within your internal company guidelines.

Our aim is to provide a standardised, industry-wide approach to engaging patients and instil a culture of partnership working between life science industry organisations and patients. The NIHR is in a unique position to be able to broker this relationship as a neutral, public sector organisation, working in close partnership with the NHS, with a long history and track record of supporting the life science industry to deliver clinical research in the NHS.

How the service works

This animation provides an overview of how the service works (less than 4 minutes). For more details read the Information Sheet for Life Sciences Organisations. When you are ready to use the service, simply complete the study submission form.

This service is a ‘paid for’ extension of the NIHR Study Support Service provided by the NIHR Clinical Research Network and is based on a transparent and fair full cost recovery model.

Information for patients

Watch this video (under 4 minutes) to find out what it means to be a patient participant in the service . If you would like to contribute to this service, read our Information Sheet for Patients.

If you are a patient, carer or member of the public and you are new to research, you may find the Patients and Public section of our website helpful.

If you are a member of a Patient Organisation that is interested in working with us, please complete the Patient Organisation Expression of Interest Form.

Contact details

Get in touch

If you are not ready to submit your study and would like to talk to a member of our team email us at: pecd@nihr.ac.uk

Provide feedback

We value  your views. Submit feedback, comments or questions about the Patient Engagement in Clinical Development service, by completing our feedback form.

Further information and resources

Video: Patient perspective: What does patient centricity look like? (2018)
Watch this video (under 4 minutes) to hear patient perspectives on being involved in designing clinical research. Please note this video was created in May 2018 and the Patient Engagement in Clinical Development service is now an established service.

Blog with video: The balancing act: How patient engagement can improve recruitment and retention (May 2019) 
In this blog and linked video (approximately 3 minutes), Dr William van't Hoff (formerly a Consultant Paediatric Nephrologist and now CEO of the NIHR Clinical Research Network), explains how the service helps life science companies to balance the 'ask' of research with the burden of disease.

Case study: Pfizer and the NIHR leading patient engagement in lockdown 
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 phase II trial of a new treatment.

Case study: The NIHR facilitates patient input into Servier’s first Sjögren’s Syndrome trial 
Discover how direct engagement with patients, facilitated by the NIHR, has had a positive impact on Servier’s proposed phase 2 trial.

Case study: Translating intention into action
Hear a Pfizer representative and a patient research ambassador describe how the NIHR collaborated with Pfizer, patients and clinicians to design and pilot this new service.

Article: A Patient-Centric Approach To Increase Recruitment And Retention In Clinical Trials (April 2019) 
This in-depth article discusses how a new national approach to involving patients and the public in the U.K. is helping life sciences companies to achieve patient-centric trial designs.

Blog with video: Bridging the gap between patients and the life sciences industry (May 2019) 
Research Patient Ambassador, Keith Wilson, is passionate about patient involvement. He discusses how he has been helping the NIHR to bring patients and life science companies together to improve clinical research delivery.

Blog: Young people are the future (May 2019) 
An NIHR representative talks to members of Generation-R (a Young People’s Advisory Group) about when and why young people should be involved in the clinical development process.

Blog: Developing a blueprint for patient engagement (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.

Patient Engagement in Clinical Development Service documents

• Information Sheet for Life Sciences Organisations
• Information Sheet for Patients
• Get started: Submit your study form
• Service Charter
• Patient Organisation Expression of Interest Form

Find out more about how we support the life sciences industry to plan and deliver high quality clinical research

• The NIHR Study Support Service for the life sciences industry
  

Additional resources

NIHR has created a range of resources which you may find useful, although these have not been designed specifically for commercial clinical research:

• UK Public Involvement Standards
• Payment policies and guidance
• How to involve people in research (Framework)
• Plain English Summaries
• Being Inclusive in Health Research
• Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project

Frequently asked questions (FAQs)

Is it patient-centric, patient-centred or people-focussed clinical research?

Different terminology is favoured in different industries and in 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 seems to be the most commonly used terminology throughout the life sciences industry.

Who is the NIHR patient Engagement in Clinical Development service for?

This service has been specifically designed to overcome some of the challenges experienced by the life sciences industry, when engaging directly with patients.

If you are a patient, carer or member of the public and would like to know more about opportunities to be involved in clinical research, please visit the Patients, Carers and Public section of our website.

How much does the NIHR patient Engagement in Clinical Development cost?

The service uses a fixed cost model which depends on the type of engagement and number of participants and can be adapted to your specific needs. Please get in touch to discuss your requirements and potential costs.