CSP094: National Patient Recruitment Centres

The Department of Health and Social care (DHSC) has contracted with five NHS Trusts, each within a different Local Clinical Research Network (LCRN), for the provision of a National Patient Recruitment Centre (PRC).

The purpose of PRCs is outlined in the PRC Remit Principles (Appendix A). They offer rapid set-up, standardised contracting and delivery approaches, and dedicated facilities and staff for late phase commercial contract research. 

Partnership working is required between three stakeholders (PRC programme office, LCRNs and the PRCs) for successful delivery of the PRC operating model. A paper to describe these partnership working arrangements was developed and agreed, in consultation with the relevant LCRN Chief Operating Officers (COOs), the PRC Clinical Directors (CDs) and the CRNCC, through conversations facilitated by the PRC Programme Office.

The expectations of LCRN support to the National Patient Recruitment Centres are listed in the  Local Clinical Research Network (LCRN) Performance and Operating Framework (POF) section 24.

The following sections provide further detail into the responsibilities of the LCRNs, when working in partnership with the PRCs and the PRC Programme Office (based in the CRNCC), in support of successful delivery of the PRC operating model. They cover the areas of Performance, Management, Financial Management and Governance.

With respect to performance of, and key performance indicators that apply to, the PRCs, the following will apply:

1. PRC recruitment to CRN Portfolio studies will be included in LCRN activity and performance figures.  

2. PRC studies will use the CRN Study Support Service as for any other NIHR CRN Portfolio study.  

3. PRCs will be designated as separate sites within LPMS and CPMS systems so that PRC recruitment can be identified at a site level, regionally or nationally as required. 

4. Study performance monitoring will be provided by the Performance Review Lead (PRL) as for any other NIHR CRN Portfolio study. 

5. During regular performance monitoring activities conducted by the PRL and/or LCRN, there may be issues identified that require PRC national Programme Office (PO) involvement. In these circumstances, the PRC PO will work with the PRC to resolve, and with the LCRN and PRL to agree to any additional supportive actions.  

6. The Central Portfolio Management System (CPMS) notes will be used by the PRC Programme Office to communicate to the LCRNs of any actions undertaken (at a study level) for transparency.  

7. The role of the PRL and lead LCRN on commercial and Investigator Initiated Trials ( IIT) studies will remain the same irrespective of PRC involvement and will require clear communication between the PRL/Lead LCRN and PRC PO in relation to performance management to avoid duplication of work.  

8.  The PRCs will be performance managed by the PRC Programme Office against 'PRC specific' Key Performance Indicators agreed with the DHSC.

9. PRC performance will be reported to the PRC Programme Board for governance and oversight purposes. 

10. The PRC Programme Office will send quarterly and annual performance reports, provided by the PRCs, to their respective LCRNs for information sharing purposes.

11. The LCRN may share the performance of the PRC within their regional footprint on an annual basis to their Executive or Partnership Group.  There are no reporting requirement expectations of the PRCs in this regard.

1. Day to day management of the PRCs is the responsibility of the PRC Clinical Directors and local management arrangements in place at the PRC Host Organisation.

2. Each individual PRC should ensure regular meetings with the LCRN through their established management structures to ensure collaboration and partnership working.

1. Each individual PRC Host should report an Annual Financial Plan with quarterly finance returns, via the NIHR CRN Finance Tool or any other system specified by National CRN Coordinating Centre, to agreed deadlines. This is separate to the LCRN finance returns.

2. Each individual PRC Host should report Commercial Income Plans as specified by the NIHR CRN Coordinating Centre.

3. The DHSC Seed funding should be ring-fenced in the PRC Host Trust accounts and managed according to the DHSC/PRC Host contract.

4. The NIHR CRNCC will provide  guidance, support, and oversight of financial sustainability and growth  plans.

1. The NIHR CRNCC (Clinical Research Network Coordinating Centre) acts as the DHSC’s managing agent for the PRC contracts via the PRC Programme Office. Governance and oversight of the PRC programme as a whole is undertaken by the PRC Internal Oversight Group (IOG), including representation from NIHR CRNCC, and reports via to the CRNCC Executive board, as per any other CRNCC Optional Service.

2. Currently, there is no direct  contractual  relationship between the PRCs and LCRNs. However, there is a key collaborative working relationship between the PRCs and the LCRNs and the PRC programme office as described in the PRC operations manual.

1. Work collaboratively with PRC Communications to generate and publish web content

2. Sense check and quality check all web content provided via the PRC Communications Link before publication. Specifically, monitoring NIHR style, tone, audience relevance, ensuring all content meets the NIHR's website accessibility standards, and suggesting changes where required.

3. Amplify and promote PRC social media content on LCRN social media channels where appropriate

4. Proactively flag any local PRC news or case studies to the PRC Programme Office for distribution on national NIHR website and social media

5. Support PRC presence at local and regional events

6. Support requests to secure local press coverage in collaboration with PRC Communications Link and Host Trust Communications

7. Attend PRC marketing communications sub group meetings held by the National Programme Office.

• To describe the principles surrounding the types of studies that the NIHR Patient Recruitment Centres (PRCs) should support. 

• To act as guidance to Patient Recruitment Centres when developing their commercial research portfolio, and that of the whole collective.

1. Phase of study - PRCs will support late phase commercial  studies (Phase III - Phase IV).  PRCs may occasionally support Phase II studies where there is a clear strategic need (and available capacity) to support.  In the main, Phase II studies will be supported by other parts of the NIHR/NHS infrastructure.

2. Size of study - PRCs will support late phase commercial research studies of varying size and complexity.  The PRCs are primarily aimed at delivering commercial studies requiring a large volume of patients, but can also support smaller studies targeting specific therapeutic areas/patient populations in line with their different demographics and areas of disease prevalence.  The PRC Programme Office will proactively reach out to the Life Science Industry around larger-scale studies for collaborative delivery across the PRC Franchise.

3. Therapeutic areas - PRCs will support commercial studies in any condition, reflecting their local strengths. Commercial studies in common chronic conditions managed in the community (e.g. asthma, IBS (Irritable Bowel Syndrome), cardiovascular conditions, respiratory disease and type 2 diabetes) will form particular areas of focus, however, PRCs will also support studies involving patients managed in the secondary care setting.  PRCs will collaborate  with other healthcare organisations in their regions to increase recruitment from the local community.  PRCs will support the PRC Programme Office in maintaining a list of capabilities for each centre to support business development.

4. Collective approach - PRCs will collaborate with each other to increase opportunities for commercial contract studies to be delivered across multiple PRC sites.  This ‘collective’ approach is critical in making it easier and quicker for commercial companies to set up and deliver research studies in the NHS.   PRCs should share opportunities they are interested in pursuing with the PRC Programme Office which will support them to facilitate multiple PRC involvement  in studies where possible.  

5. Investigator Initiated commercial collaborative studies - The prioritisation levels within the DHSC Eligibility Criteria for NIHR Clinical Research Network Support will apply to the PRCs. PRCs will prioritise support to late phase commercial contract studies, as per this policy and the PRC programme aims.  If a PRC has capacity, it may support Investigator Initiated commercial collaborative studies.  In the case of an individual PRC, support for this type of study should be discussed and agreed with the PRC Programme Office. In the case of multiple PRCs looking to support a study, the PRC Programme Office will facilitate a discussion through the PRC Strategic Group and reach a consensus on whether PRCs will support.   

6. Portfolio studies - PRCs will only support research studies that are  on the NIHR CRN portfolio. Other opportunities for the PRC Collective to engage with / support the Life Sciences Industry are encouraged and it is noted that these may not fall under the criteria to be NIHR portfolio adopted e.g. patient simulations. 

7. Other pharma collaboration opportunities - PRCs (individually or collectively) may support collaboration with pharmaceutical companies that do not relate to a specific research study e.g. patient simulations. Collaboration opportunities which are remunerated will generally be prioritised for PRC support, given the aim for the PRCs to be financially sustainable in the future.

8. Innovation - commercial studies that involve innovative approaches to research delivery e.g. virtual, hybrid trials should form part  of the PRC portfolio.

2021/22 KPIs being proposed are as outlined below:

• Measure - Proportion of commercial contract studies  achieving or surpassing their recruitment target during their planned recruitment period, at National PRC sites

• Theme - Efficient Study Delivery

• Target / Level - 80 in first year / All PRCs collectively and each PRC individually

• Measure route - LPMS / CPMS

• Comments - Target will be reviewed annually, and ambition is to increase in future years

• Measure - Number of participants recruited* to NIHR CRN Portfolio commercial contract studies, at National PRC sites *NIHR recruitment policy definition applies

• Theme - Volume of Participant Recruitment

• Target / Level - Each PRC to propose their own target, linked to PRC annual financial sustainability plans / All PRCs collectively and each PRC individually

• Measure route - LPMS / CPMS

• Comments - PRC programme office will review and agree target with each PRC via the PRC annual plan

• Measure - Response to the question: 'I would consider taking part in research again?’ in the Participant Research Experience Survey (PRES) 

• Theme - Participant Experience

• Target / Level - 95% agree or strongly agree to this question / All PRCs collectively and each PRC individually

• Measure route - PRES responses

• Comments - Paper / digital options. Collation of numbers completed each year. No response targets in first year, review for future years.

• Measure - Number of new commercial contract studies open to recruitment, at National PRC sites

• Theme - Volume of commercial studies

• Target / Level - Each PRC to propose their own targets, linked to their annual financial sustainability plan / All PRCs collectively and each PRC individually

• Measure route - LPMS / CPMS

• Comments - PRC programme office will review and agree targets with each PRC via PRC annual plan

• Measure - Response to the statement ' Our Company would consider using the PRC(s) again' in the PRC Industry Experience Survey

• Theme - Industry Experience

• Target / Level - 90% agree / strongly agree to this question / All PRCs collectively (each PRC performance individually identified also)

• Measure route - Industry experience survey responses

• Comments - New central survey to be created (and run) by the PRC Programme Office. Collation of numbers completed each year. Include the question ' Did we meet your planned study set up date?'

• Measure - Collation of initiation metric data points (already gathered for PID submission) to allow comparison against non-PRC sites.

• Theme - Site Set up

• Target / Level - PRCs will set up each study faster than the national median study set up time / All PRCs collectively and each PRC individual

• Measure route - LPMS / CPMS

• Comments - Allows measurement of the whole study start up process including Time to contract signature. Target will be reviewed annual, and ambition is to increase in future years. 

CD: Clinical Director

COO: Chief Operating Officer

CPMS: Central Portfolio Management System

CRNCC: Clinical Research Network Coordinating Centre

DHSC: Department of Health and Social Care

LPMS: Local Portfolio Management System

IIT: Investigator Initiated Trials

IOG: Internal Oversight Group

LCRN: Local Clinical Research Network

KPI: Key Performance Indicators

PO: Programme Office

PRL: Performance Review Lead

PRES: Participant in Research Experience Survey

PRC: Patient Recruitment Centre

Version number: 1.1 

Effective from date: February 2023 

Changes from V1.0:

• 6. Marketing and Communications Support

  • New section added containing details of expectations relating to marketing and communications support.

prc@nihr.ac.uk