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National Patient Recruitment Centres question and answer

 

Contents

Patient involvement

 

How do the centres consider themselves to be 'patient-centric', and how do they intend to involve patients in their work?

Patient involvement has been critical to the NPRCs since their inception and our NPRCs have, and can demonstrate, a strong culture of patient and public involvement.

Patient centricity was a key feature of the original NPRC proposal from DHSC, and the NPRC award panel included representation from a patient whose insight directly contributed to the award outcome.

Following the awards, our five sites have been designed with a clear emphasis on the value of patient experience. Our NPRCs are designated facilities for patients throughout their research journey, offering each and every patient a personalised, concierge-style service.

To maintain the centres as 'patient centric', the NPRC Programme Office will be establishing two groups with patient representation: a National Advisory Group and a Patient Voice Group. Both of these groups will ensure the NPRCs obtain consistent patient input into the programme, influencing the evolving definition of 'patient centricity' and delivery of this into the five centres. The Patient Voice connections will also provide opportunities for patients involved with their local PRC site to support both local and national initiatives.

Do the NPRCs compete with existing hospital sites in the region for recruitment?

The aim of the NPRCs is to expand research opportunities to new patient populations. Our sites have been designed to reach patient communities and individuals with common chronic conditions who are managed outside of specialised hospital clinics. In particular within primary care: 100% of NHS trusts are research active, but only 40% recruit from primary care (despite it being the largest area of recruitment growth last year). Our NPRC sites work to fill this gap in potential recruitment.

Furthermore, our NPRCs recruitment strategies differ to those of existing hospital sites which, again, focus our recruitment into different arenas. Our proactive and inclusive approach to recruitment does not rely on the right patient walking into the right clinic at the right time. Instead, where possible, we reach out into the local community and empower patients to volunteer for research. We use health-related campaigns to raise awareness of research and drive enrollment to our rapidly expanding ‘consent to be contacted’ research registers.

Are patients and the public paid for taking part in research?

Generally no, most research studies rely on volunteers to participate. Patients and the public may be reimbursed travel expenses and the local PRC study team can advise what financial reimbursements are available for taking part. Further information about patients and the public taking part in research can be found on the NIHR Be Part of Research Website: https://bepartofresearch.nihr.ac.uk/about/frequently-asked-questions/

How do the NPRCs encourage researchers and companies to involve patients in all stages of the research journey to ensure that the research is relevant and has an optimal recruitment strategy?

The NPRCs will encourage patient involvement through their support of the NIHR Patient Engagement in Clinical Development service. This is a national programme of work which connects life science companies with patients who want to help shape and improve the design and the delivery of commercial clinical research. Further information on this service can be found here: https://www.nihr.ac.uk/explore-nihr/industry/pecd.htm


In addition to this, each PRC has its own local Patient and Public Involvement and Engagement (PPIE) programme which encourages patient involvement in all aspects of delivery of their Patient Recruitment Centre.

Do you anticipate the NPRCs leveraging the capabilities of site specific RWD and analytics tools to support patient identification to deliver recruitment?

The NPRCs will improve access to local patient populations in primary care, secondary care and the wider local health sector for recruitment into studies, and will maximise the opportunities for patient identification that are presented through unparalleled access to existing NHS real world data and integrated data systems, where appropriate.

Are patients only seen at the NPRCs or are they also seen at other research sites across the country? If only the NPRCs, how is patient travel managed?

Participants taking part in a research study being conducted at a Patient Recruitment Centre will most likely be seen at the specific centre undertaking that project. The costs of the travel required for a participant to take part in a clinical trial will be reimbursed by the company sponsoring the trial.

Our PRCs are also pioneering virtual approaches to delivering clinical trials which help to overcome geographical restrictions and make research more accessible. We have one fully virtual trial underway and further virtual trials planned for 2021.

Do the NPRCs find the patients for the sponsor, or provide tools for the sponsor to recruit?

Our NPRCs will recruit relevant participants on behalf of the sponsor using innovative and proactive recruitment strategies. These harness the recruitment potential of their local and regional health care communities, extending their recruitment reach beyond hospitals and specialist clinics.

How are trials based at the NPRCs advertised? For example, how is direct social media advertising used?

The trials based at the NPRCs will be advertised using a range of media-based methods. For example, where possible, we create health-related campaigns to reach out into the local community using techniques such as social media, local press and radio, and we’ve even been known to use adverts on pharmacy shelves.

If a specific study has ethical approval to use social media for recruitment purposes then our PRCs will support the social media strategy, where appropriate.

One example of where social media has been used to support recruitment is the Relieve-IBS-D trial being conducted at PRC:Newcastle. More information can be found here: https://local.nihr.ac.uk/news/virtual-trial-recruits-67-faster-led-by-nihr-patient-recruitment-centre-in-newcastle-in-collaboration-with-enteromed/26294

Patient benefit


How do patients benefit in areas of the country where NPRCs are not located?

By attracting more commercial research to the UK, NPRCs will increase opportunities for NHS patients to access cutting edge treatments and therapies. Partnerships, connections and collaborations across the local and regional health sector are a key feature of the NPRCs operating model and will enable wider engagement of patients across the UK. The five NPRCs are geographically distributed throughout England and offer optimum coverage of the country to maximise the chances for patients and participants to benefit.

Our PRCs are also pioneering virtual approaches to delivering clinical trials which help to overcome geographical restrictions and make research more accessible. We have one fully virtual trial underway and further virtual trials planned for 2021.

What support do the NPRCs give to research teams to allow them to provide the most effective patient benefits?

NPRCs support research teams in a number of ways. For example, at each site there is:

  • A dedicated clinical space.

  • Dedicated and highly-skilled research delivery staff to support Principal Investigators.

  • Guaranteed access to NHS services to support research delivery, specifically: pharmacy, radiology, phlebotomy, and pathology.

  • Equipment and facilities that are fit for purpose and regularly maintained by suitably qualified people.

  • Onsite facilities to store trial drugs and samples, including refrigerated and frozen storage.

  • Sample receipt, tracking and storage systems to maintain sample integrity.

Areas of research supported by the NPRCs


Do the NPRCs work with SMEs and their academic collaborators looking to collect data as part of developing the underlying research of diagnostics, or are they only intended for big pharma in later stage trials?

NPRCs are 100% focused on delivering commercial research. They will work with both large pharmaceutical companies and SMEs to support the delivery of late-phase clinical trials of new medicines or medical devices.

What kind of therapeutic areas do the NPRCs cover? Are these limited to life-threatening illnesses?

The National Patient Recruitment Centres (NPRCs) specialise in running studies looking at common chronic conditions (e.g. IBS, migraines, asthma, diabetes). Each centre also provides distinct opportunities to access different demographics and areas of disease prevalence. So, although the NPRCs are purpose-designed to deliver phase 3 and 4 commercial trials requiring a large volume of patients, they can also support smaller studies targeting specific therapeutic areas (e.g. cardiovascular, dementia, dermatology, gastroenterology, oncology, ophthalmology).

Are NPRCs also able to support social care research? With the likelihood of an increased focus on care home research and community based research?

The NPRCs are able to support commercially sponsored social care research.

Further information on how the NIHR supports research in social care can be found here: https://www.nihr.ac.uk/explore-nihr/specialties/social-care.htm#:~:text=Social%20care%20research%20can%20change,for%20researchers%20in%20the%20specialty

Further information on how the NIHR supports research in the community can be found here: https://www.nihr.ac.uk/partners-and-industry/industry/run-your-study-in-the-nhs/delivering-research-in-the-community.htm

These sites seem to be heavily focused on Pharma research- are device trials appropriate for these centres?

The NPRCs are able to support the delivery of all late-phase commercial contract research, including projects related to clinical investigations of medical devices.

Do the NPRCs get involved in phase 1 and phase 2 studies at all?

The NPRC Programme was set-up to focus on the delivery of large late-phase commercial clinical trials (phase 3 and phase 4). Other NIHR infrastructure exists to provide support to early phase and experimental medicine research e.g. NIHR Clinical Research Facilities (CRFs) and Biomedical Research Centres (BRCs). Further information on these facilities can be found here: https://www.nihr.ac.uk/explore-nihr/support/experimental-medicine.htm

Trial logistics


Is there a single contact that the sponsor can approach to discuss a new trial who would then liaise with all the NPRCs or does the sponsor need to contact individual NPRCs separately?

For general enquiries about the NPRCs, and advice on how they could support a new trial, please contact the National PRC Programme Office: prc@nihr.ac.uk. We will then inform the NPRCs of the trial on your behalf. The NPRCs can also be approached through the NIHR Study Support Service site identification process. Further information on the NIHR Study Support Service and how this works can be found here: https://www.nihr.ac.uk/explore-nihr/support/study-support-service-industry.htm 

Is there a capacity limit? Could the existing network of 5 NPRCs cope if global industry really does come to the UK with many more studies?

The very concept of the NPRCs is an evolution of how we deliver commercial research in the NHS environment. It represents a significant development in the NIHR research infrastructure - the first family of research facilities to be 100% dedicated to commercial research. They will provide additional capacity to support research in the UK, and if successful, there is potential for both the programme to expand and also for each centre to expand its service and build greater capacity to support commercial research.

How significant is NPRC capacity to conduct similar clinical trials simultaneously? For example, it was mentioned that a COVID-19 vaccine study is successfully ongoing at the NPRCs. In this scenario, are NPRCs able to accommodate other similar COVID-19 phase 3 trials, or are the current NPRC centres at capacity with the running of the current COVID-19 vaccine trial?

NPRCs have capacity to conduct similar clinical trials simultaneously. They have initially provided excellent support to the delivery of COVID-19 vaccine research in the UK and as these studies are delivered, this will create additional capacity for them to support further COVID-19 vaccine research, late-phase COVID-19 studies (particularly those classed as urgent public health) and late-phase research that is unrelated to COVID-19.

Do the centres support commercially supported but investigator-led trials?

The NPRCs primarily support clinical trials that are sponsored by a commercial company. This may exclude support to non-commercially sponsored investigator led trials. If you wish to discuss a specific trial that you feel the NPRCs may be able to support, please get in touch at prc@nihr.ac.uk

Do the centres advise industry if studies aren't robust enough to recruit or retain well, and if the studies should have some PPI?

This type of advice is already available - completely free of charge - through the NIHR Early Feedback service, which is part of the NIHR’s Study Support Service.

Accessing this service will help you to determine if your study is compatible with UK clinical practice and if it can be delivered in the NHS. Our nationwide network enables us to efficiently and rapidly provide you with feedback from NHS clinical experts from the relevant therapeutic area. Our experts will look at elements such as study complexity, patient population, time lines and recruitment strategy. They will offer valuable suggestions to improve study design and delivery and increase the potential of achieving your recruitment target on time. Further information can be found here: https://www.nihr.ac.uk/partners-and-industry/industry/access-to-expertise/early-feedback-service.htm

Does the sponsor need to set up and negotiate the contract with the PRC or the hospital trust?

The NPRCs operate a single costing model where one lead PRC will negotiate the contract and costs for delivering that study with a Sponsor, on behalf of all the other PRCs involved.

Once agreed, each PRC has a dedicated person responsible for contract negotiation and the PRC host organisation will be the contracting party.

What is the ambition for trial set-up time?

All five NPRCs adhere to the new national contract value review process which utilises standardised costing and contracting processes, and uniquely, the NPRCs operate a single costing model, which requires just one costing negotiation for all five centres with minimal local variation.

Through the application of these new approaches across the NPRCs (e.g. franchise-like model/single costing model), the aim is that the NPRCs will achieve ‘best in class’ study start up times.

How would the NPRCs manage from a resourcing standpoint? If they are high throughput, this would require a very large and consistent research team at each site to manage the number of trials.

Each PRC has a core dedicated staff team available to support the delivery of a commercial research study. This is made up of positions including: Business Manager, Pharmacist, Pharmacy Technician, several Research Nurses, Research Support staff e.g. Data Managers and a Centre Receptionist/Administrator. They are 100% dedicated to delivering commercial research and will work in collaboration with local Principal Investigators, research teams and other healthcare organisations to create additional capacity to deliver late-phase research. It is hoped that each PRC will grow, expand and build their capacity over time as they develop their commercial portfolio.

How will the NPRCs handle competing trials and sponsors?

The NPRCs are happy to work with any commercial organisation to support the delivery of late phase commercial research that will provide opportunities for patients to benefit from early access to innovation. Where competing trials or sponsors becomes an issue, PRC sites can support sponsors to identify other PRCs, or additional sites that may be able to provide support, through the NIHR Study Support Service or the PRC Programme Office.

Does each PRC site have a small, defined team dedicated to a trial indication and/or sponsor? Will the same team be available for future trials for the same sponsor?

Each PRC has the same core dedicated team of research delivery staff available to support a commercial study. This team includes a clinical director, a lead manager, several research nurses, pharmacy staff and other research supporting roles. They support research across a broad range of specialities or indications, and provide support to many sponsoring companies. The NPRCs are keen to work in close partnership with Pharmaceutical companies to maximise the opportunities for patients to benefit from early access to innovation and new therapies in the UK. In this regard, they welcome the opportunity to provide support to future trials involving sponsors they have already collaborated with.

How do the NPRCs assess capacity to say yes to taking on a clinical trial? Is there a booking system or window for types of trials/indications and a maximum number that can be taken on?

The NPRCs are purpose-designed to increase the UK’s capacity to deliver large scale, late-phase commercial clinical trials and to make it easier and quicker to deliver commercial research in our NHS.

Systems are being developed across the NPRC network to maximise their capacity to deliver commercial contract research for the global life sciences industry. There are no booking systems in place as yet to utilise the PRC service and if you are a life science company looking to run a study through the NPRCs, please contact the National Patient Recruitment Centre Programme Office by email: prc@nihr.ac.uk.

We always advise companies to get in touch as soon as possible to maximise opportunities to benefit from NIHR services.

If PIs who are consultants or KOLs are used, how much time will they dedicate to being on site at the NPRC?

Principal Investigators taking responsibility for the conduct of a clinical trial being delivered at a NPRC will dedicate sufficient time and resources to ensure it is delivered in a safe and effective manner. This will work in a very similar way to existing arrangements for Principal Investigator support to research being conducted at any NHS site.

Will the PIs be based at the trust? If so, how will this be captured on the CT application form?

The NPRCs can provide access to, and engagement from, NHS clinicians working across a wide range of therapeutic areas to work as the Principal Investigator or Chief Investigator for a commercial contract study, many of whom are world-renowned. Their input would be captured on the Clinical Trials Application form in the usual way.

What about pharmacy and imaging service capacity? Would these services be based at the hospital trust?

Each PRC research team has a dedicated PRC Pharmacist (based in their host organisation) as part of their core PRC research team. NPRCs also have access to imaging services either on-site at their hospital trust, or through a third party (i.e. outsourced) in their local region.

The NPRCs have had great success with a fully virtual trial. Can you share more information on this? For example, was the protocol designed specifically for virtual conduct or was this adapted due to the current environment?

The RELIEVE IBS-D trial is testing a new treatment for Irritable Bowel Syndrome with Diarrhoea (IBS-D). Over 70 weeks, before the pandemic, it had already randomised 224 patients at 28 sites in England, including GP, hospital and private clinics.
Until September, participation had been limited to the catchment areas of those 28 sites. The new virtual approach, which has been developed by the team at the NIHR Patient Recruitment Centre in Newcastle, has extended the reach of this trial to IBS-D patients throughout the UK, with patients now participating in England, Wales, Scotland and Northern Ireland - from their own homes.
The virtual expansion of the trial has also resulted in rapid recruitment and randomisation of participants, with the 50th participant being randomised on 17th November, just two months since the study opened on 16th September 2020. This means that the virtual version of the trial has significantly out-performed the site-based version of the trial - one site using a virtual approach has recruited 67% faster than 28 sites using a traditional approach.

More information on the virtual delivery of the Relieve IBS-D trial at Patient Recruitment Centre: Newcastle can be found at the following link: https://local.nihr.ac.uk/news/virtual-trial-recruits-67-faster-led-by-nihr-patient-recruitment-centre-in-newcastle-in-collaboration-with-enteromed/26294
 

Costing


Will the NPRC budget and contract flow down to the Pharma industry sponsor through the NPRC's partnering Trust/trial site?

The NPRCs represent a significant Government investment to boost commercial research in the UK. The Government has allocated £7 million to fund the five new Patient Recruitment Centres and each centre is receiving approximately 1.3 million over a 3 year period. This funds a core dedicated team of research delivery staff at each centre that is available to support delivery of commercial research studies.

With all this talk about the efficient budget and contract timelines, is the timeline to start recruitment not still reliant on the ability of the Principal Investigator (who may not be based at a PRC site) to move quickly through the budget and contract process? How can the NPRCs influence that part of the process?

All five centres work collaboratively through an innovative ‘franchise-like’ model and operate in an identical manner to make it easier and quicker to deliver commercial research. A key aspect of this is that the centres operate a single costing model which requires just one costing negotiation for all five centres, with minimal local variation. It is through these new approaches to costing and contracting that the NPRCs will collectively reduce the timeline to start recruitment.

Is there a cost for working with the NPRCs?

The NPRCs follow the standardised, national approaches to costing and contracting for commercial contract research that are underpinned by national costing methodology (the NIHR costing tool or template and National tariff workbooks). There are no additional costs for running your study at a Patient Recruitment Centre.
 

Potential Challenges

 

How are the NPRCs managing the COVID-19 pandemic? Are they protected or are they halted as trials at other sites have been?

All the NPRCs are working to the national guidance for research prioritisation. The three levels of prioritisation set out within the Restart Framework still apply to the NPRCs given that they are NIHR infrastructure.

How are the UK and the NPRCs attractive to global pharma?

NPRCs are the first family of NIHR-funded research infrastructure that is 100% dedicated to delivering commercial research. The centres are dedicated to setting up and delivering large late-phase commercial clinical trials at pace and scale, and are fully embedded in the NHS, the largest single health care provider in the world. The NPRCs franchise like model approach makes it easier and quicker to deliver commercial research and, through these new innovative approaches to research delivery, the NPRCs will improve the UK’s competitiveness in the global market.

Are the centres able to support undertaking more research activities in people's own homes at a time when they may be less willing to come to a healthcare setting?

The NPRCs offer a unique opportunity to pilot new approaches to research delivery in the UK, e.g. virtual, hybrid and decentralised trials. Within the first few months of operation, PRC:Newcastle had commenced delivery of one of the UK’s first fully virtual commercial interventional trials. Further virtual trials are planned for 2021 and we expect the NPRCs will support the delivery of many more virtual trials in the future.

Misc



Were industry representatives consulted in the setting up of the NPRCs?

Yes, multiple stakeholders from across the UK healthcare research system were involved in the set up of the NPRCs, including industry representatives. Through our newly formed PRC Advisory group, which includes several industry representatives, they will continue to provide advice and recommendations to inform successful delivery of the centres. We also regularly seek feedback and advice from The Association of the British Pharmaceutical Industry (ABPI) and its members.

Many GP surgeries do not have any research experience and so either do not apply for studies or are rejected. Will these centres give training to those surgeries that want to become more experienced and gain knowledge to apply for commercial studies?

The NPRCs would like to collaborate with GP surgeries to enable access to a wider cohort of patients to get involved in commercial research. The PRC teams have a wealth of commercial expertise and experience gained from delivering commercial research in the NHS and will share that knowledge and experience with those they collaborate with to improve the set up and delivery of late-phase commercial clinical trials in the UK. Please contact us at prc@nihr.ac.uk and we can advise how the NPRCs may be able to support. Local Clinical Research Networks (LCRNs) can provide support to primary care organisations to help them gain knowledge and experience in commercial research delivery. Further information and useful points of contact can be found here: https://local.nihr.ac.uk/lcrn/

Do the NPRCs set up the agreements with GPs, community care, PICs and advertising groups etc. directly on the sponsor’s behalf?

The NPRCs will collaborate with their surrounding local healthcare system e.g. with NHS Trusts, GPs, Care Homes, Hospices and other healthcare providers to enable patient referral and recruitment. These agreements will be formed with the relevant local organisations either by the PRC or by the sponsor, as appropriate, to enable the specific research projects to be delivered.