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 NIHR CRN reports progress against annual performance on a quarterly basis to the Department of Health and Social Care and a summary is made publicly available on this website. During each reporting year, HLO data is refreshed on a quarterly basis to provide a more accurate picture of annual performance. The NIHR CRN takes ongoing action to address underperformance and continuously works towards meeting the national HLO targets.
This page provides a summary of performance for 2018/19 (for the annual period 1 April 2018 to 31 March 2019). Performance is summarised in Table 1.
Table 1 - High Level Objectives Performance Summary Data for 2018/19 (1 April 2018 - 31 March 2019)
| Objective | Annual Target | Annual Performance | % Difference from Annual Target | 2014/15 | 2015/16 | 2016/17 | 2017/18 | 2017/18 % Difference from Target |
|---|---|---|---|---|---|---|---|---|
| 1: Increase the number of research participants | 650,000 | 870,250 [G] | +34% | 618,453 | 605,596 | 666,639 | 725,333 | +12% |
| 2A: Increase the proportion of research studies funded by life sciences companies that are delivered in line with the study's planned participant recruitment target and delivery time | 80% | 69% [R] | -14% | 63% | 65% | 73% | 74% | -8% |
| 2B: Increase the proportion of studies funded by non-commercial organisations that are delivered in line with the study's planned participant recruitment target and delivery time | 80% | 82% [G] | +3% | 76% | 76% | 83% | 80% | +0% |
| 3A: Increase the number of studies funded by life sciences companies which are supported by the CRN | 700 | 740 [G] | +6% | 623 | 650 | 729 | 697 | +3% |
| 3B: Increase the proportion of new studies funded by life sciences companies which have received clinical trial authorisation | 75% | 75% [G] | 0% | 82% | 85% | 88% | 79% | +5% |
| 4: Reduce the time it takes for a research studies to be set up and started at each research site | 80% | 71% [R] | -11% | New metric for 2016/17 | New metric for 2016/17 | 60% | 66% | -18% |
| 5A: Reduce the time it takes to recruit the first participant into research studies which are funded by life sciences companies | 80% | 33% [R] | -59% | New metric for 2016/17 | New metric for 2016/17 | 36% | 35% | -56% |
| 5B: Reduce the time it takes to recruit the first participant into research studies funded by non-commercial organisations | 80% | 46% [R] | -42% | New metric for 2016/17 | New metric for 2016/17 | 49% | 49% | -39% |
| 6A: Increase the proportion of NHS Trusts which are active in research | 99% | 100% [G] | +1% | 98% | 100% | 99% | 99% | +0% |
| 6B: Increase the proportion of NHS Trusts which are active in research funded by life sciences companies | 70& | 79% [G] | +13% | 78% | 74% | 79% | 82% | +17% |
| 6C: Increase the proportion of General Medical Practices active in research | 45% | 38% [R] | -16% | 41% | 42% | 48% | 32% | -20% |
| 7: Increase the number of participants involved in research into dementias | 25,000 | 42,024 [G] | +68% | 21,449 | 34,812 | 28,240 | 33,208 | +48% |
The Red, Amber and Green thresholds used in Table 1 above, are:
- Red/letter [R]: the NIHR CRN has achieved less than 90% of the performance target
- Amber/letter [A]: the NIHR CRN has achieved 90% or more of the performance target but less than 100% of the performance target
- Green/letter [G]: the NIHR CRN has achieved 100% or more of the performance target
Performance Summary for 2018/19
Details of 2018/19 performance for each of the HLOs is provided below:
Increase the number of research participants (HLO 1)
- 870,250 participants were recruited into clinical research studies during 2018/19, 20% above last year’s performance and 34% higher than the HLO 1 target.
- HLO 1 performance is heavily influenced by 61% of recruitment from large recruiting studies (recruiting over 1,000 participants) in 2018/19, of which 26 studies were interventional and 103 were observational, 2017/18 performance was at 53%. Within this group of large recruiting studies, there are a small number of very high-recruiting studies (11 studies contributed 22% of recruitment (195,650 participants) and the 100,000 Genome study alone contributed 35,789 of the total annual recruitment.
- The NIHR CRN Portfolio of studies continues to grow steadily, with participants recruited in 5,126 studies (225 more studies than in 2017/18). In 2018/19 there were 2194 new studies, an increase of 124 from 2017/18. A total of 6,106 studies were supported by the CRN in 2018/19, an increase of 302 from 2017/18. There has been growth in all study categories in 2018/19.
- Average participant recruitment per percentage of population in 2018/19 is 1.65%, which is an increase of 0.25% achieved in 2017/18.
Increase the proportion of research studies funded by life sciences companies that are delivered in line with the study's planned participant recruitment target and delivery time (HLO 2A)
- 69% of commercial contract studies delivered recruitment to time and target, which is a modest reduction compared to 74% in 2017/18. Work to align Network and model Clinical Trial Agreement site targets has been initiated which may have been a contributing factor, but has been widely supported by life sciences industry partners. Further work continues in 2019/20 to improve a partnership approach to target setting and feasibility.
- 484 studies contributed to HLO 2A in 2018/19, 4% (18) higher when compared to 2017/18.
- The NIHR CRN continues to demonstrate a consistently low percentage (12.5%) of sites that fail to recruit any participants.
- The NIHR CRN continues to focus on Specialty portfolios which require further improvement to further develop the overall performance of HLO 2.
Increase the proportion of studies funded by non-commercial organisations that are delivered in line with the study’s planned participant recruitment target and delivery time (HLO 2B)
- 82% of non-commercial studies delivered recruitment to time and target. This has been achieved for the third consecutive year and consistently within all four quarters.
- 912 studies contributed to HLO 2B in 2018/19, 6% (51) more than in 2017/18. The non-commercial study Portfolio has demonstrated increased performance despite the CRN supporting an increased volume of studies.
- The NIHR CRN continues to focus on Specialty portfolios which require further improvement to maintain and further develop the overall performance.
Increase the number of studies funded by life sciences companies which are supported by the CRN (HLO 3A)
- 740 new commercial contract studies were added to the NIHR CRN Portfolio, surpassing the target, making 2018/19 the highest number of new studies to date. This growth has been achieved in a year containing considerable uncertainty for commercial organisations due to Brexit.
- 15 Global first patients and 11 European first patients were recruited into commercial contract studies, highlighting that the trial set up process remains globally competitive.
Increase the proportion of new studies funded by life sciences companies which have received clinical trial authorisation (HLO 3B)
- The number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II-IV studies was 75%, meeting the target for the seventh year running.
Reduce the time it takes for a research study to be set up and started at each research site (HLO 4)
- 71% of eligible studies achieved NHS set up at all sites within 40 calendar days in 2018/19, compared to 66% in 2017/18. The number of studies contributing to this measure has also increased significantly (1,613, compared to 1,437 last year).
- 2018/19 data utilises data points that are aligned across the national study set up process, including NIHR and HRA. This is beginning to provide a comprehensive picture of the whole study set up timeline.
- NIHR CRN Portfolio study level data completeness is at 92% (of 1,752 possible studies, 1,613 reported start-up activities) and Trust level completeness has improved (93% of minimum expected data completed). This has been achieved through the connectivity of local and national systems through CPMS/LPMS.
- To ensure that the NIHR CRN continues to focus on improving performance and reducing the time taken for study site set-up for NIHR CRN Portfolio studies, a new HLO will be introduced in 2019/20 (HLO 9). This will measure and aim to reduce the intra-study variability in set up times from “Date Site Selected” to “Date First Participant Recruited”.
Reduce the time it takes to recruit the first participant into research studies which are funded by life sciences companies (HLO 5A)
- 33% of commercial contract studies achieved first participant recruited within 30 days at confirmed Network sites in 2018/19. There are issues around the consistency of measurement and data entry making it difficult to draw conclusions about performance. These are being addressed through ongoing activity across NHS England, NIHR and HRA to provide greater alignment.
- To ensure that the NIHR CRN continues to focus on improving performance and reducing the time taken for study site set-up for NIHR CRN Portfolio studies, a new HLO will be introduced in 2019/20 (HLO 9). This will measure and aim to reduce the intra-study variability in set up times from “Date Site Selected” to “Date First Participant Recruited”.
Reduce the time it takes to recruit the first participant into research studies funded by non-commercial organisations (HLO 5B)
- 46% of non-commercial studies achieved first participant recruited within 30 calendar days at confirmed Network sites in 2018/19. In 2018/19 performance was measured for 924 studies, compared to 834 in 2017/18. There are issues around the consistency of measurement and data entry making it difficult to draw conclusions about performance. These are being addressed through ongoing activity across NHS England, NIHR and HRA to provide greater alignment.
- To ensure that the NIHR CRN continues to focus on improving performance and reducing the time taken for study site set-up for NIHR CRN Portfolio studies, a new HLO will be introduced in 2019/20 (HLO 9). This will measure and aim to reduce the intra-study variability in set up times from “Date Site Selected” to “Date First Participant Recruited”.
Increase the proportion of NHS Trusts which are active in research (HLO 6A)
- 100% of NHS Trusts recruited into NIHR CRN Portfolio studies in 2018/19. This was last achieved in 2015/16 and supports the CRN ambition to improve equity of access to research opportunities for people across England.
Increase the proportion of NHS Trusts which are active in research funded by life sciences companies (HLO 6B)
- 79% of NHS Trusts recruited to commercial contract studies, surpassing the target of 70% (190 of 230 trusts) and sustaining the upward trend in performance since 2015/16.
Increase the proportion of General Medical Practices active in research (HLO 6C)
- 38% of General Medical Practices (GMPs) recruited participants into NIHR CRN Portfolio studies in 2018/19, compared to 32% in 2017/18. This is a cumulative annual metric whereby any General Medical Practice that has recruited to NIHR CRN Portfolio studies within 2018/19 is included.
- The increased number of federated practices nationally has reduced the overall number of GMPs, which impacts upon the performance of this metric. The introduction of Primary Care Networks may impact upon future performance and the associated impact and measure for primary care participation in research needs to be monitored.
Increase the number of participants involved in research into dementias (HLO 7)
- 42,024 participants were recruited into Dementias and Neurodegeneration (DeNDRoN) Specialty studies and the annual performance is significantly above target (25,000 participants) for the fifth year running.
- 8 large studies (recruiting over 1,000 participants) contributed 65% of the total annual recruitment.
- Recruitment into other DeNDRoN Portfolio studies remains stable, between 4,000 to 5,000 participants per quarter.
Table 2 - NIHR CRN High Level Objectives
| Objective | Measure | 2018/19 Target | |
|---|---|---|---|
| 1 | Increase the number of participants recruited into NIHR CRN Portfolio studies | Number of participants recruited in a reporting year into NIHR CRN Portfolio studies | 650,000 |
| 2 |
Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time
|
Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites
Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period |
80%
80% |
| 3 | Increase the number of commercial contract studies delivered through the NIHR CRN |
Number of new commercial contract studies entering the NIHR CRN Portfolio
Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II–IV studies |
700
75% |
| 4 | Reduce the time taken for eligible studies to achieve set up in the NHS | Proportion of eligible studies achieving NHS set up at all sites within 40 calendar days (from “Date Site Selected” to “Date Site Confirmed”) | 80% |
| 5 | Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies |
Proportion of commercial contract studies achieving first participant recruited within 30 days at confirmed Network sites (from “Date Site Confirmed” to “Date First Participant Recruited”)
Proportion of non-commercial contract studies achieving first participant recruited within 30 days at confirmed Network sites (from “Date Site Confirmed” to “Date First Participant Recruited”) |
80%
80% |
| 6 | Increase NHS participation in NIHR CRN Portfolio Studies |
Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies
|
99%
70%
45% |
| 7 | Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio | Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio | 25,000 |
Notes
This report is produced by the CRN Coordinating Centre (CRNCC), which is responsible for collating and publishing performance data for the NIHR CRN as a whole.
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.
The data presented on this page may be quoted in presentations and papers. However, we ask that the title and version are included, to avoid any confusion about the period to which the figures relate and the time at which the data were reported.
Abbreviations
CPMS - Central Portfolio Management System
CTA - Clinical Trial Agreement
HRA - Health Research Authority
LPMS - Local Portfolio Management System
MHRA - Medicines and Healthcare products Regulatory Agency
Further information
For feedback on, or queries relating to, the information contained in this document, please contact:
Dr Andrew Walker, Head of Performance Management
CRN Coordinating Centre
Email: andrew.walker@nihr.ac.uk