Introduction
The NIHR Clinical Research Network (CRN) High Level Objectives (HLOs) are our national, overarching objectives for research delivery. Delivery against these objectives is central to ensuring sustained or improved performance of our priority activities. Increasing opportunities for people to participate in research is essential, underpinned by continuous improvement in the set up and delivery of research and active engagement with the NHS and other health and social care providers.
The figures presented on this page relate to performance between April 2019 and March 2020.
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 Clinical Research Networks (LCRN) and CRN Specialties. Quarter 4 2019/20 HLO reporting is based upon both confirmed and provisional research activity data received via Local Portfolio Management System plus confirmed manually uploaded research activity data.
Performance in 2019/20
The NIHR CRN made good progress during 2019/20 in delivering against HLO performance ambitions. We supported the second highest ever number of people to access opportunities to participate in research. This is a testament to the commitment and hard work of all the staff, researchers and organisations involved in ensuring the efficient delivery of research, maximising the research opportunities for participants across England.
Deliver significant levels of participation in NIHR CRN Portfolio studies (HLO1)
| Measure | Ambition | Annual performance | Ambition met |
|---|---|---|---|
| Number of participants recruited to NIHR CRN Portfolio studies (HLO 1A) | 700,000 | 732,176 | Yes |
| Number of participants recruited to commercial contract NIHR CRN Portfolio studies (HLO 1B) | 40,000 | 28,832 | No |
Number of participants recruited to NIHR CRN Portfolio studies (HLO 1A)
- 732,176 participants were recruited into clinical research studies during 2019/20, our second highest performance to date and 5% higher than the HLO 1A ambition.
- HLO 1A performance is heavily influenced by 59% of recruitment from studies each recruiting over 1,000 participants in 2019/20, of which 31 studies were interventional and 87 were observational, 2018/19 performance was at 61%. Within this group of studies 8 studies contributed 15% of recruitment (111,432 participants).
- Participants were recruited in 4,900 studies in 2019/20, slightly less than in 2018/19 (5,126) and similar to 2017/18 (4,901). In 2019/20 there were 2,103 new studies, a slight decrease compared to 2018/19, when there were 2,194 new studies, but higher than in 2017/18 (2,070 new studies). A total of 6,052 studies were supported by the CRN in 2019/20, a slight decrease from the 6,106 studies supported in 2018/19.
Number of participants recruited to commercial contract NIHR CRN Portfolio studies (HLO 1B)
- 28,832 participants were recruited into commercial contract NIHR CRN Portfolio studies (HLO 1B), 11,168 below the 40,000 annual ambition and performance in 2015/16 to 2018/19.
- Strong performance in the last few years has been due to a few studies that recruited over 1000 participants. Collectively, these studies contributed 26% of recruitment in 2019/20, a decrease from the 41% contributed by equivalent studies in 2018/19. In 2019/20 30% of recruitment was from commercial contract studies recruiting over 500 participants, compared to 51% and 46% in 2018/19 and 2017/18, respectively. The number of commercial contract studies recruiting over 1000 participants will continue to influence annual performance.
- There remains a consistent level of 5,000-6,000 participants per quarter amongst smaller studies.
- 1,166 studies have recruited participants in 2019/20, an increase of 17 compared to 2018/19, continuing the upward trend in the number of recruiting studies.
Deliver NIHR CRN Portfolio studies to recruitment target within the planned recruitment period (HLO 2)
| Measure | Ambition | Annual performance | Ambition met |
|---|---|---|---|
| Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at CRN confirmed sites (HLO 2A) | 80% | 70% | No |
| Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period (HLO 2B) | 80% | 87% | Yes |
Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at CRN confirmed sites (HLO 2A)
- 70% of commercial contract studies delivered recruitment to time and target, which is a slight increase compared to 69% in 2018/19, although it is still below the 80% ambition.
- 351 studies contributed to HLO 2A performance in 2019/20, which is considerably lower than in 2018/19 (484 studies) or 2017/18 (466 studies). The number of studies that have been closed and included in this metric this year may have been affected by the ongoing embedding of the research activity confirmation process and prioritisation of the COVID-19 response.
- Further work has continued in 2019/20 to improve a partnership approach to target setting and feasibility.
- The NIHR CRN continues to demonstrate a consistently low percentage of sites that fail to recruit any participants. Only 9.4% of sites in closed commercial contract studies did not recruit any participants in 2019/20, the fewest since 2016/17.
- The NIHR CRN continues to focus on the LCRNs and Specialty portfolios which require further improvement to further develop the overall performance of HLO 2.
Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period (HLO 2B)
- 87% of non-commercial studies delivered recruitment to time and target. This objective has been achieved for the fourth consecutive year and consistently within all four quarters.
- 777 studies contributed to HLO 2B in 2019/20, this is considerably lower (332 studies) than in 2018/19 and a change in the trend in the number of studies, which has increased by an average of 57 studies each year since 2013/14. The number of studies that have been closed and included in this metric this year may have been affected by the ongoing embedding of the research activity confirmation process and prioritisation of the COVID-19 response.
- 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 delivered for the commercial sector with support from the NIHR Clinical Research Network (HLO3)
| Measure | Ambition | Annual performance | Ambition met |
|---|---|---|---|
| Number of new commercial contract studies entering the NIHR CRN Portfolio (HLO 3A) | 750 | 671 | No |
| 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 (HLO 3B) | 75% | 77% | Yes |
Number of new commercial contract studies entering the NIHR CRN Portfolio (HLO 3A)
- 671 new commercial contract studies were added to the NIHR CRN Portfolio, which is below the 750 annual ambition and performance in 2016/17 to 2018/19.
- The fall in the number of studies may be linked with continued uncertainty for commercial organisations due to Brexit, and we will be undertaking year-on-year analyses of the number of commercial companies with studies entering the NIHR CRN Portfolio and the total number of requests for site feasibility services to look for underlying changes. Reduction, in part, as gathered via soft intelligence, can be attributed to the decline of the smaller international biotech and medtech companies, who have been cautious delivering trials for their single product/therapy in the UK, given the uncertainties of Brexit.
- 14 Global first patients and 11 European first patients were recruited into commercial contract studies, highlighting that the trial set up process remains globally competitive.
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 (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 77%, exceeding the 75% ambition and meaning we have exceeded or met the 75% annual ambition/target for the sixth year running.
- It appears there may be a decrease in the total number of MHRA approvals relative to 2018/19.
HLO 4 and 5 have been withdrawn for this financial year and replaced with 9 - see below.
Widen participation in research by enabling the involvement of a range of health and social care providers (HLO 6)
| Measure | Ambition | Annual performance | Ambition met |
|---|---|---|---|
| Proportion of NHS Trusts recruiting in NIHR CRN Portfolio Studies (HLO 6A) | 99% | 100% | Yes |
| Proportion of NHS Trusts recruiting into NIHR CRN Portfolio commercial contract studies (HLO 6B) | 70% | 75% | Yes |
| Proportion of General Medical Practices recruiting into NIHR CRN Portfolio studies (HLO 6C) | 45% | 36% | No |
| Number of non-NHS sites recruiting into NIHR CRN Portfolio studies (HLO 6D) | 2,000 | 2,135 | Yes |
Proportion of NHS Trusts recruiting into NIHR CRN Portfolio Studies (HLO 6A)
- 100% of NHS Trusts recruited into NIHR CRN Portfolio studies in 2019/20. This is the second successive year we have achieved full participation and supports the CRN’s ambition to improve equity of access to research opportunities for people across England.
Proportion of NHS Trusts recruiting into NIHR CRN Portfolio commercial contract studies (HLO 6B)
- 75% of NHS Trusts (169/226) recruited to commercial contract studies, surpassing the ambition of 70% for the sixth year in succession.
Proportion of General Medical Practices recruiting into NIHR CRN Portfolio studies (HLO 6C)
- 36% of General Medical Practices (GMPs) recruited participants into NIHR CRN Portfolio studies in 2019/20, below the 45% ambition and slightly below performance in 2018/19 (38%). This is a cumulative annual metric whereby any General Medical Practice that has recruited to NIHR CRN Portfolio studies within 2019/20 is included.
- In 2016/17, our highest performing year to date, performance (48%) was considerably and atypically influenced by a single study (TIME) which recruited at over 1,800 GMPs, without which performance would have been 36% (the value achieved in 2019/20) and may therefore be a misleading comparator.
- Performance in the first three quarters of 2019/20 was slightly higher than at the equivalent points in 2018/19 (reaching 34% at Q3). However, performance in Q4 was reduced compared to the same quarter in 2018/19. This may have been due to the emerging coronavirus pandemic.
- 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.
Number of non-NHS sites recruiting into NIHR CRN Portfolio studies (HLO 6D)
- 2,135 non-NHS sites have recruited into NIHR CRN Portfolio studies in 2019/20, exceeding the annual ambition of 2,000 by ~7%. This is a cumulative annual metric whereby any non-NHS site that has recruited to NIHR CRN Portfolio studies in 2019/20 is included. It is notable that a single study in schools that closed in Q2, contributed 1,599 sites and 75% of performance. This is a growth area for delivery of CRN service support; opportunities to grow research in non-NHS settings are increasing as research designed for delivery in these settings is created, funded and ultimately enters the NIHR CRN Portfolio for CRN service support.
Deliver significant levels of participation in NIHR CRN Portfolio Dementias and Neurodegeneration (DeNDRoN) studies (HLO 7)
| Measure | Ambition | Annual performance | Ambition met |
|---|---|---|---|
| Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio each year | 25,000 | 24,321 | No |
Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio each year
- 24,321 participants were recruited into Dementias and Neurodegeneration (DeNDRoN) Specialty studies. This is slightly below (3%) the 25,000 annual ambition and considerably lower (42%) than performance in 2018/19, which was the highest annual performance to date.
This difference in performance is not unexpected as the small proportion of studies recruiting greater than 500 participants continue to create significant variation in quarterly and annual HLO 7 performance. In 2018/19 eight studies each recruiting over 1,000 participants contributed 65% of the total annual recruitment, whereas only four equivalent studies in 2019/20 recruited 6,337 participants, contributing 26% of the total annual recruitment. - Recruitment into other DeNDRoN Portfolio studies remains stable at around ~4,000 participants per quarter.
Demonstrate to people taking part in health and social care research studies that their contribution is valued (HLO 8)
| Measure | Ambition | Annual performance | Ambition met |
|---|---|---|---|
| Number of NIHR CRN Portfolio study participants responding to the Patient Research Experience Survey each year | 10,000 | 21,862 | Yes |
Number of NIHR CRN Portfolio study participants responding to the Patient Research Experience Survey each year
- 21,862 NIHR CRN Portfolio study participants have responded to the Patient Research Experience Survey (PRES) in 2019/20, more than double the annual ambition value of 10,000 and a considerable increase on 2018/19 performance (8,507 respondents). The 2019/20 response rate represents 2.5% of total participants who took part in NIHR CRN Portfolio studies in 2018/19.
- Performance includes data for all 15 LCRNs and is based on responses to adult surveys that include the nationally mandated questions. 14/15 LCRNs have achieved an increased PRES response rate compared to 2018/19.
- In addition, a number of the LCRNs (8/15 LCRNs) also offered a Children’s survey and two LCRNs also conducted a survey of carers, providing a proxy for participants who are not able to respond to PRES independently. These additional surveys received a total of 1,060 and 56 responses respectively, in 2019/20.
Reduce study site set-up times for NIHR CRN Portfolio studies by 5%* (HLO 9)
| Measure | Ambition | Annual performance | Ambition met |
|---|---|---|---|
| Median study site set-up time for commercial contract studies, at confirmed Network sites (days) (HLO 9A) | 80 | 74 | Yes |
| Median study site set-up time for non-commercial studies (days) (HLO 9B) | 60 | 57 | 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.
Median study site set-up time for commercial contract studies at confirmed Network sites (days) (HLO 9A)
- As a new HLO, this metric set out to reduce the intra-study variability in the set up of commercial studies across sites. The NIHR CRNCC worked with LCRNs and the R&D Forum to provide support in improving set up times.
- The median study site set-up time for commercial contract studies, at confirmed Network sites is 74 days in 2019/20. This is 7% ahead of the ambition of reducing the median intra-study site set-up time for NIHR CRN Portfolio studies to 80 days.
- The median intra-study site set-up time for commercial contract studies was 86 and 101 days in Q3 and Q4, respectively. Performance later in the year may be more reflective of the true median time for study site set-up. This is because the number of study sites with data available to contribute to this new metric in Q1 and Q2 was small and by Q3 and Q4 performance can include sites which may have considerably longer set-up times.
Median study site set-up time for non-commercial studies (days) (HLO 9B)
- As a new HLO, this metric set out to reduce the intra-study variability in the set up of non-commercial studies across sites.
- The median study site set-up time for non-commercial studies is 57 days in 2019/20. This is 5% ahead of the quarterly ambition of reducing the median intra-study site set-up time to 80 days.
- The median study site set-up time for non-commercial studies is 62 days and 60 days in Q3 and Q4, respectively. Performance later in the year may be more reflective of the true median time for study site set-up. This is because the number of study sites with data available to contribute to this new metric in Q1 and Q2 was small and by Q3 and Q4 performance can include sites which may have considerably longer set-up times.
- This data will continue to help provide a baseline for assessing future initiatives to reduce this variability.
Notes
The CRN Coordinating Centre (CRNCC) 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 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.
Abbreviations
MHRA - Medicines and Healthcare products Regulatory Agency
CT - Clinical Trials
Further information
For feedback on, or queries relating to, the information contained on this page, please contact CRN Coordinating Centre:
Dr Andrew Walker, Head of Performance Management by email.