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NIHR Clinical Research Network High Level Objectives Outturn Report 2022/23

Contents

Published: 09 August 2023

Version: August 2023

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Introduction

The High Level Objectives (HLOs) are the NIHR Clinical Research Network’s (NIHR CRN) national, overarching annual objectives for research delivery in the NHS and other health and social care settings.

The HLOs form 1 element of the suite of performance indicators used to assess the Network’s performance. 

This page sets out the NIHR CRN performance against its HLOs for 2022/23 (1 April 2022 to 31 March 2023).

Performance reporting

  • Following the COVID-19 pandemic, the UK clinical research delivery system is facing unprecedented challenges to support the delivery of research. The ongoing impact of the pandemic on elective backlog, workforce pressures, as well as the need to complete COVID-19 research, has led to delays in the start-up and completion of studies. This has resulted in a substantial reduction in the number of studies able to recruit effectively and close on time. In response to the ongoing challenges in research delivery, the Department of Health and Social Care (DHSC) has introduced the Research Reset programme with the aim of making portfolio delivery achievable within planned timelines (time and target) and sustainable within the resource and capability we currently have in the NHS. It aims to free up capacity across the research system, by working with funders and sponsors to support the review of studies that have already completed, or that are unlikely to be able to deliver their endpoints in the current environment. DHSC has asked the NIHR CRN to assist with data provision and maintenance of the data integrity of the portfolio during this process.
  • Performance presented in this report should be considered against the backdrop of research recovery and Research Reset.

Overall Performance against the HLOs

Overall performance in 2022/23 was excellent; the NIHR CRN met or exceeded the annual ambitions for 9 out of the 10 HLO measures and was very close to achieving the annual ambition for the other measure. Given the constraints on NHS and social care organisations at this time, all our partners should be commended for their hard work and dedication.

Performance in 2022/23

Efficient Study Delivery: Deliver NIHR CRN Portfolio studies to recruitment target within the planned recruitment period 

Measure

Ambition

Annual performance

Ambition met

(4) Percentage of closed to recruitment commercial contract studies which have achieved their recruitment target *

  80%  80%  Yes

(5) Percentage of closed to recruitment non-commercial studies which have achieved their recruitment target *

 80% 90% Yes

(6) Percentage of open to recruitment commercial contract studies which are predicted to achieve their recruitment target **

 60%  68%  Yes

(7) Percentage of open to recruitment non-commercial studies which are predicted to achieve their recruitment target **

 60% 66% Yes

* Annual performance is calculated as the sum of the number of studies that recruited to time and target across all available quarters divided by the total number of studies which closed to recruitment across all available quarters, expressed as a percentage.

** Open RTT measures are 'point in time' and are as per the date of the data cut date and not the quarter end date. They are not, and cannot be, retrospectively updated in later quarters. 

(4) Percentage of closed to recruitment commercial contract studies which have achieved their recruitment target 

  • 80% (n=269/336) of commercial contract studies which closed in 2022/23 achieved their recruitment target. This is the first year that the NIHR CRN has met the annual ambition.
  • Performance data includes commercial contract studies;
    • which are not part of Research Reset, or
    • which are identified in Research Reset, where recruitment to target is equal to or greater than 100% or where the sponsor’s agreed intention is ‘On track as per key milestones’.
  • Work is continuing to enable accurate reporting of performance in the context of Research Reset and the wider Research Recovery, Resilience and Growth programme. There are practical considerations around the objectives of Research Reset, in encouraging studies which are not deliverable to close, and the general ambition to close studies within time and to target.

(5) Percentage of closed to recruitment non-commercial studies which have achieved their recruitment target

  • 90% (n=755/838) of non-commercial studies which closed in 2022/23 achieved their recruitment target, exceeding the annual ambition of 80% and the highest annual performance to date.
  • Performance data includes commercial contract studies;
    • which are not part of Research Reset, or
    • which are identified in Research Reset, where recruitment to target is equal to or greater than 100%, or where the sponsor’s agreed intention is ‘On track as per key milestones’.
  • Work is continuing to enable accurate reporting of performance in the context of Research Reset and the wider Research Recovery, Resilience and Growth programme. There are practical considerations around the objectives of Research Reset, in encouraging studies which are not deliverable to close, and the general ambition to close studies within time and to target.

(6) Percentage of open to recruitment commercial contract studies which are predicted to achieve their recruitment target

  • 68% (n=715/1,057) of commercial contract studies which were open to recruitment at the point of the Q4 datacut (21 April 2023) were considered ‘On Track’ to deliver either in a data-driven manner (i.e. via the recruitment to time and target (RTT) rating) or by way of Sponsor-provided Intention, as per the Research Reset programme. This exceeds the annual ambition of 60%. 
  • This is a new measure introduced in v2.0 of the 2022/23 NIHR CRN High Level Objectives. Performance data for the two new Efficient Study Delivery Open to Recruitment measures (ESD6 and ESD7) reflect a point in time on a dynamic dataset. Therefore this data cannot be retrospectively updated.

(7) Percentage of open to recruitment non-commercial studies which are predicted to achieve their recruitment target

  • 66% (n=2,002/3,036) of non-commercial studies which were open to recruitment at the point of the Q4 datacut (21 April 2023) were considered ‘On Track’ to deliver either in a data-driven manner (i.e. via the recruitment to time and target (RTT) rating) or by way of Sponsor-provided Intention, as per the Research Reset programme. This exceeds the annual ambition of 60%. 
  • This is a new measure introduced in v2.0 of the 2022/23 NIHR CRN High Level Objectives. Performance data for the two new Efficient Study Delivery Open to Recruitment measures reflect a point in time on a dynamic dataset. Therefore this data cannot be retrospectively updated. 


Provider Participation: Widen participation in research by enabling the involvement of a range of health and social care providers

Measure

Ambition

Annual performance

 Ambition met

(3) Percentage of General Medical Practices with recruitment in NIHR CRN Portfolio studies ***

  45%  44%  No

(4) Percentage of NHS Acute trusts with recruitment in NIHR CRN Portfolio studies every quarter ****

  99%  100% Yes 

(5) Percentage of NHS Acute trusts with recruitment in commercial contract NIHR CRN Portfolio studies every quarter ****

  70%  74% Yes 

(6) Percentage of NHS Ambulance, Care and Mental Health trusts with recruitment in NIHR CRN Portfolio studies every quarter **** 

 95% 95% Yes

*** Annual performance is calculated as the sum of each unique site that has recruited one or more participants in one or more available quarters divided by the total number of sites, expressed as a percentage.

**** Annual performance is calculated as the sum of each unique site that has recruited one or more participants in every available quarter divided by the total number of sites, expressed as a percentage.

(3) General Medical Practices 

  • 44% (n=2,875/6,541) of General Medical Practices (GMPs) recruited one or more participants into NIHR CRN Portfolio studies in 2022/23, slightly below the annual ambition of 45%.
  • Historically, performance has been influenced by studies with a large sample size and the associated requirement for many recruiting sites. This continues to be the case, with 2022/23 performance underpinned by the PRINCIPLE platform study (CPMS ID: 45457), GP Teams study (CPMS ID: 44270) and the LOLIPOP 100K study (CPMS ID: 44841). These 3 studies have recruited in a combined total of 2,211 GP practices (34% of the possible total number of practices).
  • In addition there was substantial primary care recruitment to the PANORAMIC study in year. Due to its decentralised nature only 28% of recruitment was attributable to primary care sites. However the hub and spoke model meant that other GMP sites functioned as spokes (471 spoke sites) and serviced 83 recruiting hubs, but without formal research activity attribution.
  • The performance reported underestimates the overall contribution of research activity by GMPs, as it does not include those sites which identify patients for referral into studies being delivered elsewhere, nor does it reflect the number of sites supporting studies providing follow-up activities.
  • Many GMPs work as groups, either across a Federation or Primary Care Network, to offer research opportunities to wider patient populations. In the current model of measurement, recruitment activity in these situations is attributed to a lead practice, and therefore does not fully capture the level of engagement of GP practices and studies available to patients. Work is underway to fully explore the wider GMP participation and how to report this.

(4) NHS Acute trusts - All studies

  • 100% (n=137/137) of NHS Acute trusts have recruited into NIHR CRN Portfolio studies in 2022/23, exceeding the annual ambition of 99%.
  • This HLO has been refined for 2022/23 to reflect greater and sustained research activity; in order to achieve the ambition a NHS trust must recruit one or more participants each quarter, rather than one or more participants each reporting year. 

(5) NHS Acute trusts - Commercial studies

  • 74% (n=101/137) of NHS Acute trusts have recruited into commercial contract studies in 2022/23, exceeding the annual ambition of 70%.
  • This HLO has been refined for 2022/23 to reflect greater and sustained research activity; in order to achieve the ambition a NHS trust must recruit one or more participants each quarter, rather than one or more participants each reporting year.

(6) Percentage of NHS Ambulance, Care and Mental Health trusts - All studies

  • 95% (71/75) of NHS Ambulance, Care and Mental Health Trusts have recruited in NIHR CRN Portfolio studies in 2022/23, meeting the annual ambition of 95%. This HLO has been refined for 2022/23 to reflect greater and sustained research activity; in order to achieve the ambition a NHS trust must recruit one or more participants each quarter, rather than one or more participants each reporting year. 

Participant Experience: Demonstrate to people taking part in health and social care research studies that their contribution is valued

MeasureAmbitionAnnual PerformanceAmbition Met
Number of NIHR CRN Portfolio study participants responding to the Participant Research Experience Survey, each year *****  14,000 32,603 Yes

***** Annual performance is the sum of the number of responses across all available quarters.

  • 12,322 NIHR CRN Portfolio study participants responded to the Participant Research Experience Survey (PRES) in Q4 2022/23, bringing the total number of responses for 2022/23 to 32,603. This is more than double the annual ambition of 14,000, and is the highest annual performance to date.
  • Performance is based on responses to Adult and Children’s surveys which include age-appropriate questions that correlate to the adult survey. A total of 30,705 adult responses from the 15 LCRNs have contributed to the 2022/23 performance. In addition, 13 LCRNs have received a combined total of 1,898 from children and young people (defined as being under 16 years of age). These figures represent considerable increases on the numbers of responses received in 2021/22. Adult responses have increased by 21% (n=30,705 vs. n=25,459), while responses from children and young people have increased by 653% (n=1,898 vs. n=252).
  • Separately, 52 responses have been received for local, alternative surveys (n=42 for Dementia Friendly, n=1 for Learning Disability and n=9 for Ambulance Trust).

Expanding our work with the life sciences industry to improve health and economic prosperity 

Measure

Ambition

Annual performance

 Ambition met

(1) Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total MHRA CT approvals for PHASE II-IV studies ******

  75%  108%  Yes

****** Annual performance is calculated as the sum of new studies entering the NIHR CRN Portfolio divided by the total MHRA CT approvals across all available quarters, expressed as a percentage. A figure in excess of 100% can occur if the quarterly flow of studies onto the NIHR CRN Portfolio is higher than the flow of studies through the MHRA CT approval process

Commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total MHRA CT approvals for PHASE II-IV studies

  • The number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CT approvals for Phase II-IV studies was 108% (n=513/474 studies) in 2022/23, greater than the annual ambition of 75%.
  • Performance indicates the NIHR CRN Portfolio continues to accept life science studies as they come into the UK, demonstrating the UK is open for life science business.
  • The two sets of study data utilised in this metric are unconnected; the metric reflects the number of studies entering the Portfolio and the number of studies receiving MHRA CT approval.

Notes

  1. The CRN Coordinating Centre is responsible for collating and publishing performance data for the NIHR CRN as a whole.
  2. For the purposes of performance reporting decimal places are rounded up or down to the nearest whole number. The information contained in this report represents the most complete information available at the time of publication.
  3. The data presented on this page may be quoted in presentations and papers. However, we ask that the page title, publication date, version and URL are included, to avoid any confusion about the period to which the figures relate and the time at which the data were reported.

Further information

For feedback on, or queries relating to, the information contained on this page, please contact Dr Andrew Walker, Head of Performance Management at CRN Coordinating Centre: crncc.performance@nihr.ac.uk