This site is optimised for modern browsers. For the best experience, please use Google Chrome, Mozilla Firefox, or Microsoft Edge.

NIHR Clinical Research Network High Level Objectives Outturn Report 2020/21

Contents

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. They are reported on an annual basis to the Department for Health and Social Care (DHSC) and the summary is made publicly available via the NIHR website.
The HLOs form one element of the suite of performance indicators which are used to assess the Network’s performance.

This page sets out the NIHR CRN performance against its HLOs for 2020/21 (1 April 2020 to 31 March 2021).

Performance reporting and COVID-19

The emergence of the COVID-19 pandemic in early 2020 led the NHS to suspend many routine clinical services and the NIHR to prepare to support the Government’s research response. Subsequently, decisions taken in March 2020 by research sponsors, funders, investigators and study sites to pause some non-COVID-19 research led to a rapid and significant reduction in NIHR research activity. Recruitment activity for the NIHR CRN Portfolio stopped in many instances, and our routine data-cut activities and processes for receiving and confirming research activity data may also not have been completed, even where recruitment has occurred. This will have impacted the HLO performance reported and the impact may be variable across studies, Local CRNs and CRN Specialties.

NIHR CRN continued to prioritise the delivery of its portfolio of research in accordance with the three levels of prioritisation set out in the NIHR Restart Framework. NIHR CRN activity, including that evidenced by the HLOs, will reflect this prioritisation.

Performance in 2020/21

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

MeasureAmbitionAnnual
performance
Ambition
met
Proportion of new commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed CRN sites 70% 74% Yes

Proportion of new commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed CRN sites

  • 74% of studies (25 out of 34) have been delivered to time and target in 2020/21, exceeding the 70% ambition and improving upon the 70% achieved in 2019/20. Twelve of the studies included in this metric in 2020/21 are Urgent Public Health (UPH) studies, of which eight (67%) recruited to time and target. Four priority (see note 4 in the notes section below) UPH vaccine and prophylactic studies closed in 2020/21, with three of these delivered to time and target. The effective delivery of early vaccine candidates and the rapid roll out of the deployed vaccine programme has led to challenges in the UK in implementing later vaccine candidate trials, including unblinding, placebo controlled randomisation and recruitment from already vaccinated age groups. Despite this the NIHR CRN achieved 75% delivery to time and target for this group of studies.
  • The proportion of commercial contract studies achieving recruitment to time and target in Quarter (Q) 4  2020/21 was 84% (16 out of 19 studies), an improvement on both the Q2 and Q3 positions when, following the Q4 data refresh, 40% (2 out of 5) and 50% (3 out of 6) respectively, of the studies which contributed to this metric recruited to time and target. Performance in 2020/21, is a considerable achievement given the impact of the first and second waves of the pandemic on NHS services, and the focus on prioritisation of UPH research studies.

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

MeasureAmbitionAnnual
performance
Ambition
met
(A) Proportion of NHS Trusts recruiting into NIHR CRN Portfolio studies 99% 100% Yes
(B) Proportion of NHS Trusts recruiting into NIHR CRN Portfolio commercial contract studies 70% 66% No
(C) Proportion of General Medical Practices recruiting into NIHR CRN Portfolio Studies 45% 50% Yes
(D) Number of non-NHS sites recruiting into NIHR CRN Portfolio studies 2,250  491 No

(A) Proportion of NHS Trusts recruiting into NIHR CRN Portfolio studies 

  • 100% of NHS Trusts (N=219) recruited into NIHR CRN Portfolio studies in 2020/21. The annual ambition was met in Q2 2020/21. Even within the restrictions of the COVID-19 pandemic, research activity continued across England, including delivery of the UPH platform studies which were open at multiple sites. As would be anticipated, there is variation in the spread of research activity across England, with thirty (14%) NHS Trusts accounting for 53% of secondary care recruitment in 2020/21, and the remaining 47% of recruitment shared amongst the remaining 189 (86%) NHS Trusts.

(B) Proportion of NHS Trusts recruiting into NIHR CRN Portfolio commercial contract studies

  • 66% of NHS Trusts recruited to commercial contract studies in 2020/21, narrowly missing the 70% ambition. 2020/21 performance is lower than the 75% achieved in 2019/20. In 2020/21 144 NHS Trusts recruited into NIHR CRN Portfolio studies compared with 169 in 2019/20 and 182 in 2018/19. Performance in 2020/21, compared with previous years, is reflective of the impact of the pandemic on routine clinical care services, including the pausing of commercial contract research to enable NHS Trusts to deliver frontline care where necessary, and the nationally prioritised COVID-19 studies. The CRN continues to prioritise the delivery of UPH badged studies as part of the Government response to tackle the pandemic. While there was a fall in provider participation in commercial studies in 2020/21, the number of commercial participants increased compared to 2019/20, from 28,832 to 35,488 (+23%). 
  • 57% of commercial recruitment in 2020/21 came from 16 UPH studies, which recruited at 48 NHS trusts. Work on restoring research across the NIHR CRN will continue in 2021/22 through the Managing Recovery programme.

(C) Proportion of General Medical Practices recruiting into NIHR CRN Portfolio Studies

  • 50% of General Medical Practices recruited one or more participants into NIHR CRN Portfolio studies in 2020/21. This is a cumulative annual metric, whereby any GP practice that has recruited to NIHR CRN Portfolio studies in 2020/21 is included.
  • Performance in 2020/21 exceeds the annual ambition of 45% and annual performance in 2019/20 (36%). Historically, performance has been heavily influenced by studies with a large sample size, requiring many recruiting sites, and performance in 2020/21 has been boosted considerably from Q3, by the UPH PRINCIPLE platform study, where the design was adapted to reflect new ways of working in response to COVID-19 and demonstrated successful virtual trial delivery. Recruitment took place at 2,310 (34%, N=6,778) GP practices for this study by the end of 2020/21. The NIHR CRN has recently developed a primary care research strategy. Explicit within the strategy is a desire to improve performance, in addition to creating greater opportunities for the wider primary care research community, patients and the public to participate in NIHR CRN research.

(D) Number of non-NHS sites recruiting into NIHR CRN Portfolio studies

  • 491 non-NHS sites recruited one or more participants into NIHR CRN Portfolio studies in 2020/21, which is considerably below the annual ambition of 2,250. Not surprisingly, performance has been impacted throughout 2020/21 by the pandemic and factors such as the closure of many schools during the first and second national lockdowns. Performance in this metric over the last two years has been heavily influenced by two studies. In 2020/21 performance has been boosted by the UPH VIVALDI study which recruited at 191 care homes. Additionally, approximately two-thirds of non-NHS sites that recruited in 2019/20 were involved in a single dental study, which is now closed.

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

MeasureAmbitionAnnual
performance
Ambition
met
Number of NIHR CRN Portfolio study participants responding to the
Participant in Research Experience Survey, each year
12,000 20,892 Yes

Number of NIHR CRN Portfolio study participants responding to the Participant in Research Experience Survey, each year

  • 9,506 NIHR CRN Portfolio study participants responded to the Participant in Research Experience Survey (PRES) in Q4 of 2020/21, contributing to a total of 20,892 study participant responses in 2020/21.
  • 2020/21 performance is based on responses to adult and children’s surveys that include the same national standardised questions, with age appropriate wording. 20,749 adult responses from 15 LCRNs have contributed to 2020/21 performance (over 99% of the total).
  • It should be noted that due to prioritisation of the COVID-19 response, delivery of the PRES was delayed due to lockdown in March/April 2020, deployment of research delivery staff to support COVID-19 efforts, and the pausing of some non-COVID-19 research by research sponsors, funders, investigators and study sites. While the pandemic undoubtedly had an impact on performance in the first two quarters, Q3 and Q4 and annual performance greatly exceeded the quarterly and annual ambition of 3,000 and 12,000, respectively. This is a considerable achievement given the pandemic and it is very positive to have received valuable feedback on their research experience from all the participants who have responded this year, including participants from UPH badged studies, including vaccines studies.

Urgent Public Health (UPH): Minimise set-up times for NIHR CRN UPH Portfolio studies*

MeasureAmbitionAnnual
performance
Ambition
met
Study site set up time (working days) 9 3 Yes

* This HLO aims to achieve a reduction in study set-up time therefore the annual performance number aims to be equal to, or less than, the ambition number.

Study site set up time (working days)

  • The median study site set-up time for UPH studies was 3 working days in 2020/21, based on 68 studies (33 in Q1, 10 in Q2, 14 in Q3 and 12 in Q4). Of the 68 studies, 55 set up their first site in 9 working days or less. Annual performance includes 15 commercial studies with a median study set-up time of 4 days and 53 non-commercial studies, with a median study set-up time of 2.5 days. These timelines are considerably better than the ambition of 9 working days, suggesting the value of working as a collective to a common purpose in the set-up of UPH studies.
  • There are an additional 18 studies for which the date of first site confirmed is still to be reported. These outstanding data points highlight the reliance on manual data entry into local systems capturing their confirmation of site capacity and capability for each study.

Restart: Restart the NIHR CRN Portfolio paused by Sponsors and Sites due to COVID-19

MeasureAmbitionAnnual
performance
Ambition
met
(A) Percentage of paused commercial contract studies that are no longer paused at 31 March 2021 80% 81% Yes
(B) Percentage of paused non-commercial studies that are no longer paused at 31 March 2021 80% 77% No

(A) Percentage of paused commercial contract studies that are no longer paused at 31 March 2021

  • 81% (N=302) of a baseline of 374 commercial contract studies which were paused on 21 May 2020 were no longer paused, exceeding the ambition of 80%.
  • Of the 302 ‘unpaused’ studies, 129 (43%) have opened and recruited, 92 (30%) have returned to set-up or normal suspension or closed/withdrawn normally, 19 (6%) were stopped or cancelled due to the pandemic, and the remaining 62 (21%) have opened and are yet to recruit. Of the remaining 72 studies still paused at the end of Q4 2020/21, 29 are in set-up and 43 paused to recruitment.

(B) Percentage of paused non-commercial studies that are no longer paused at 31 March 2021

  • 77% (N=1,711) of a baseline of 2,2182 non-commercial studies which were paused on 21 May 2020 were no longer paused, slightly lower than the ambition of 80%.
  • Of the 1,711 ‘unpaused’, 1,041 (61%) studies have opened and recruited, 400 (23%) have opened and are yet to recruit, 207 (12%) have returned to set-up or normal suspension or closed/withdrawn normally, and 63 (4%) were stopped or cancelled due to the pandemic. Of the remaining 507 studies still paused at the end of Q4 2020/21, 1 is in set-up and 506 paused to recruitment.
  • We continue to work with our life sciences and academic customers to ensure accuracy of data capture. Also, work is ongoing with our charity sector partners and NHS R&D colleagues, via the LCRNs, to better understand the challenges with restarting clinical research and in sharing best practices and areas of success, where appropriate. This progress in restoring a full and active portfolio of research across the CRN will continue in 2021/22 through the Managing Recovery programme.

Notes

  1. The CRNCC 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.
  4. These studies were designated as Level 1A priority studies as part of the nationally prioritised COVID-19 Urgent Public Health (UPH) Research studies. Level 1 studies are those identified as having the highest priority/urgency). For further details see the NIHR Restart Framework.

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