Official Statistics

UK Clinical Research Delivery key performance indicators: data to March 2026

Published 15 April 2026

Background

Overview

The UK Clinical Research Delivery (UKCRD) key performance indicators (KPIs) report brings together data from the National Institute for Health and Care Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA) to monitor the delivery of globally competitive clinical research across the UK.

The report predominately measures the performance of studies held on the NIHR Research Delivery Network’s (RDN) Central Portfolio Management System (CPMS).

The indicators have been published since January 2024 on the UKCRD programme website and were developed with input from stakeholders from across the clinical research system, including the NHS, industry, charities, academia, regulators and public contributors. They were first published on GOV.UK in December 2025 with further indicator development in April 2026. They measure trends in the speed and predictability of regulatory and study set-up times, delivery of research to time and target, and volume of clinical research activity.

Data coverage

The data in this report measures the performance of a specific subset of studies in the UK, predominantly those on the CPMS. It does not capture the performance of the entire clinical research system.

The indicators are intended to be UK-wide but currently some do not include complete data from all 4 nations. Coverage has also changed over time. Work is ongoing with devolved governments to improve completeness.

Data in this report is categorised into 3 distinct clinical research study types:

• commercial contract studies: studies sponsored and fully funded by the life sciences industry

• commercial collaborative studies: studies funded, wholly or in part, by the life sciences industry and sponsored by a combination of life sciences industry and non-commercial organisations. These studies were previously included under the non-commercial category but are now disaggregated to more accurately reflect the scope of commercial research activity. Commercial collaborative studies are supported in the same way as non-commercial studies, including provision of support costs and excess treatment costs through the NIHR RDN and the NHS.

• non-commercial studies: studies sponsored and wholly funded by one or more non-commercial organisations, including medical research charities, universities and public funders, such as NIHR and UK Research and Innovation

A further breakdown of the data by observational and interventional studies is provided in the accompanying data tables.

Data quality

For most indicators, the quality of the data reported is dependent on the accuracy, timeliness and completeness of its entry into the CPMS and local portfolio management systems by sponsors and research sites. Many of the data fields relevant to the indicators are not mandatory and are sometimes incomplete.

Delays may occur with sponsors and sites entering their data, meaning figures reported for recent months may be incomplete. Data is updated retrospectively in future reports as further information becomes available.

Short-term fluctuations in the data are not always reliable indicators of changes in performance. Users are encouraged to focus on longer-term trends (for example, over 6 or 12 months) for a more accurate view of system performance. Work is ongoing to improve the completeness and timeliness of data collection.

The time period presented in this report varies by indicator and depends on when data became complete.

Methodology

For a full explanation of data sources, data coverage, calculation methods and data quality, please refer to the UKCRD programme KPIs methodology. Details for each indicator are provided in this report.

Key performance indicators overview

In 2023, UKCRD KPI reporting set specific targets for indicators 2 to 5, but not for indicators 6 and 7. The scope of indicators 3 and 4 has changed from April 2026. Indicator 1 is a new indicator from April 2026.

Some indicators in this report have changed or been removed since its initial publication on GOV.UK in December 2025. Further details are provided in the methodology.

Table 1: UKCRD key performance indicators overview

Indicator number	Indicator description	Latest month	Latest figure	Target
1	Proportion of commercial contract clinical trial of investigational medicinal products (CTIMP) studies recruiting first participant within 150 days of applying for regulatory approval	September 2025	78%	95%
2	Proportion of studies receiving combined review approval within 60 days (or 90 days for advanced therapy investigational medicinal product (ATIMP) studies)	February 2026	99%	99%
3	Proportion of studies opening to recruitment within 60 days of Health Research Authority (HRA) approval letter or equivalent process used by the devolved governments	September 2025	58%	90%
4	Proportion of studies recruiting first participant within 30 days of opening to recruitment	September 2025	62%	90%
5	Proportion of open studies on track, delivering recruitment to time and target	March 2026	82%	80%
6	Average monthly recruitment to clinical studies	January 2026	86,151 participants	No target
7	Number of new studies added to the NIHR RDN portfolio	February 2026	154 studies	No target

Study set-up timelines

Indicator 1: proportion of commercial contract CTIMP studies recruiting a first participant within 150 days of applying for regulatory approval

This indicator is designed to assess the efficiency and predictability of the full end-to-end study set-up process, in line with the target set by the Prime Minister for cutting the time it takes to get a clinical trial set up in the UK to 150 days.

It measures the percentage of commercial contract CTIMP studies (excluding ATIMPs) on the CPMS that opened to recruitment within 150 calendar days of submission for regulatory approval by combined review.

The measure broadly links together those for indicators 2 to 4 in this report, which cover the different stages of the study set-up process:

• regulatory review
• study opening
• recruitment of the first participant

The clock starts on the date an initial clinical trial authorisation application is submitted to the Integrated Research Application System. If the applicant has chosen not to attend the first available REC meeting, the start date is set 2 weeks prior to the selected REC meeting. The clock stops on the date the first study participant is recruited.

For the regulatory review part of the 150-day metric, we are specifically measuring the time taken for MHRA and REC to complete their joint assessments of an application, without inclusion of the time taken by the applicant to respond to any requests for further information (RFI) following the initial combined assessment.

The target is for 95% of studies to recruit their first participant within 150 days of applying for regulatory approval.

Studies where recruitment of the first participant is not expected within 150 days of applying for regulatory approval (rare disease and other low recruitment studies, extension studies and studies where the sponsor has notified NIHR RDN as such) are excluded from the report.

To produce the most up-to-date results that are sufficiently complete and accurate for measuring performance of commercial contract CTIMP studies against the 150-day target, additional assurance by gathering sponsor intelligence is carried out. Where a study is missing data, the relevant sponsor is contacted to get the latest status of the study. This only applies to indicator 1. See the methodology for a full explanation of this process.

Figures for all months are subject to change and will be revised in future reports as more information becomes available.

This indicator groups studies by the month they received combined review approval. It relates to table 1 in the data tables.

Table 1.1: study set-up performance against the 150-day target for commercial contract interventional CTIMP studies by application month, including sponsor intelligence.

Application month	Percentage of studies with known status set up within 150 days	Set up within 150 days	Not set up within 150 days
April 2025	58%	7	5
May 2025	64%	9	5
June 2025	72%	13	5
July 2025	80%	12	3
August 2025	73%	11	4
September 2025	78%	7	2
Financial year 2025 to 2026 (April to September 2025)	71%	59	24

Between April 2025 and September 2025, 83 studies were set up and 59 of these (71%) recruited their first participant within 150 days of submitting their initial clinical trial authorisation application.

The results above combine CPMS data with supplementary sponsor intelligence to provide a timely and complete assessment of performance against the 150-day target. To enable comparison with earlier time periods, the following section presents analysis based on CPMS data only, using a consistent methodology across financial years.

Table 1.2 shows the counts and proportion of studies being set up within 150 days. Table 1.3 shows the median time for these studies to be set up. Proportions and averages are calculated from studies with known status.

The data in tables 1.2 and 1.3 may differ from the data in table 1.1. This reflects the inclusion of supplementary sponsor intelligence in table 1.1 that are not included for reasons of comparability in 1.2 and 1.3.

Table 1.2: study set-up performance for commercial contract interventional CTIMP studies by application month - CPMS data only

Application financial year (6-month periods)	Percentage of studies with known status set up within 150 days	Set up within 150 days	Not set up within 150 days	Unknown status	Number of studies with known status
April 2025 to September 2025	73%	53	20	11	73
October 2024 to March 2025	46%	33	38	14	71
April 2024 to September 2024	45%	37	46	4	83

Table 1.3: average study set-up duration for commercial contract interventional CTIMP studies by application month - CPMS data only

Application financial year (6-month periods)	Median number of days from application to first participant recruited
April 2025 to September 2025	122
October 2024 to March 2025	157
April 2024 to September 2024	169

Indicator 2: proportion of studies receiving combined review approval within 60 days (or 90 days for ATIMP studies)

This indicator measures the percentage of approved initial clinical trial authorisation applications in the UK that received their combined review decision within 60 calendar days, or within 90 days for ATIMPs, of regulatory submission each month. It is designed to assess the efficiency and predictability of the combined review process.

Combined review is the way approval is sought for new clinical trials of investigational medicinal products and combined medicine and device trials. It is jointly conducted by MHRA and a research ethics committee (REC).

The clock starts on the date an initial clinical trial authorisation application is submitted to the Integrated Research Application System. If the applicant has chosen not to attend the first available REC meeting, the start date is set 2 weeks prior to the selected REC meeting. The clock stops on the date when joint approval is issued by MHRA and REC on the initial clinical trial authorisation application.

We are specifically measuring the time taken for MHRA and REC to complete their joint assessments of an application. This includes the time taken both to conduct the initial combined assessment and to issue the joint decision following receipt of the applicant’s response to a request for further information (RFI).

It does not include the time taken by the applicant to respond to any RFI following the initial combined assessment. This means the clock stops once the applicant has been sent a RFI and starts again once a complete response has been submitted.

The target is for more than or equal to 99% of approved studies to receive combined review approval within 60 days (or 90 days for ATIMP studies).

This indicator groups studies by the month they received combined review approval. It relates to table 2 in the data tables.

Table 2.1: percentage of approved studies that received combined review approval within 60 days (or 90 days for ATIMP studies) in February 2026.

Study type	Percentage of approved studies that received combined review approval within 60 days (or 90 days for ATIMP studies)	Target
All	99%	99%

Table 2.2: percentage of approved studies that received combined review approval within 60 days (or 90 days for ATIMP studies)

Combined review approval month	Percentage of approved studies that received combined review approval within 60 days (or 90 days for ATIMP studies)	Number of approved studies that received combined review approval within 60 days (or 90 days for ATIMP studies)	Number of studies that received combined review approval
March 2025	98%	57	58
April 2025	100%	66	66
May 2025	96%	66	69
June 2025	98%	65	66
July 2025	97%	74	76
August 2025	98%	63	64
September 2025	100%	63	63
October 2025	98%	91	93
November 2025	100%	76	76
December 2025	99%	73	74
January 2026	97%	59	61
February 2026	99%	67	68

Indicator 3: proportion of studies opening to recruitment within 60 days of HRA approval letter or equivalent process used by the devolved governments

This indicator measures the percentage of studies on the CPMS that opened to recruitment within 60 calendar days of receiving HRA approval or equivalent process used by the devolved governments each month. It is designed to assess the efficiency and predictability of study set-up processes.

The clock starts on the date a study receives regulatory approval. The clock stops on the date a sponsor confirms the study is ready to start recruiting participants in at least one site.

Studies are grouped by the month they received regulatory approval.

The target is for 90% of studies to open to recruitment within 60 days of receiving regulatory approval.

The latest time period reported is the month 6 months prior to the report’s publication month. This is to allow sufficient time for most studies to open to recruitment, whether within 60 days or not, and to enter their data. Figures for all months are subject to change and will be revised in future reports as more information becomes available.

This indicator relates to tables 3a, 3b and 3c in the data tables.

Table 3.1: opening to recruitment performance by study type in September 2025

Study type	Percentage of studies that opened to recruitment within 60 days of regulatory approval	Number of studies that opened to recruitment within 60 days of regulatory approval	Number of studies that opened to recruitment	Target
All	58%	55	95	90%
Commercial contract	54%	20	37	90%
Commercial collaborative	50%	3	6	90%
Non-commercial	62%	32	52	90%

Table 3.2: opening to recruitment performance of studies by study regulatory approval month

Study regulatory approval month	Percentage of studies that opened to recruitment within 60 days of regulatory approval	Number of studies that opened to recruitment within 60 days of regulatory approval	Number of studies that opened to recruitment	Number of approved studies that have not yet opened to recruitment, or have not recorded doing so
October 2024	38%	57	149	2
November 2024	40%	50	124	1
December 2024	33%	38	116	7
January 2025	47%	60	127	3
February 2025	41%	48	116	13
March 2025	42%	53	126	7
April 2025	42%	48	115	8
May 2025	43%	53	122	9
June 2025	33%	38	116	13
July 2025	50%	67	135	27
August 2025	44%	48	110	21
September 2025	58%	55	95	49

Table 3.3: opening to recruitment performance of studies by study regulatory approval year

Study regulatory approval year	Percentage of studies that opened to recruitment within 60 days of regulatory approval	Number of studies that opened to recruitment within 60 days of regulatory approval	Number of studies that opened to recruitment	Number of approved studies that have not yet opened to recruitment, or have not recorded doing so
2017	53%	1,122	2,099	0
2018	51%	1,103	2,146	0
2019	49%	1,043	2,117	1
2020	30%	539	1,815	4
2021	33%	668	2,000	2
2022	35%	620	1,782	6
2023	38%	672	1,787	11
2024	35%	577	1,630	30

Figure 3.1: percentage of studies on the CPMS that opened to recruitment within 60 days of regulatory approval

Figure 3.2: average number of days taken for studies on the CPMS to open to recruitment following regulatory approval

Figure 3.1 shows the percentage of studies on the CPMS that opened to recruitment within 60 days of regulatory approval per month since 2017.

Figure 3.2 shows the average time taken for studies to open to recruitment.

During the COVID-19 pandemic, average time to recruitment was higher as the system re-prioritised its focus towards COVID-19 research.

Following the pandemic, performance returned towards pre-pandemic levels.

Indicator 4: proportion of studies recruiting first participant within 30 days of opening to recruitment

This indicator measures the percentage of studies on the CPMS that recruited their first participant within 30 calendar days of opening to recruitment each month. It is designed to assess the efficiency and predictability of study set-up processes.

The clock starts on the date a sponsor confirms the study is ready to start recruiting participants in at least one site. The clock stops on the date the first study participant is recruited.

Studies are grouped by the month they opened to recruitment.

Studies where recruitment of first participant is not expected within 30 days of opening to recruitment in the study milestone plan (that is rare disease and other low recruitment studies) are excluded from the report.

The target is for 90% of studies to recruit their first participant within 30 days of opening to recruitment.

The latest time period reported is the month 6 months prior to the report’s publication month. This is to allow sufficient time for most studies to have recruited their first participant, whether within 30 days or not, and to enter their data. Figures for all months are subject to change and will be revised in future reports as more information becomes available.

This indicator relates to tables 4a, 4b and 4c in the data tables.

Table 4.1: first participant recruitment performance by study type in September 2025

Study type	Percentage of studies that recruited their first participant within 30 days of opening to recruitment	Number of studies that recruited their first participant within 30 days of opening to recruitment	Number of studies that recruited a first participant	Target
All	62%	52	84	90%
Commercial contract	52%	15	29	90%
Commercial collaborative	40%	2	5	90%
Non-commercial	70%	35	50	90%

Table 4.2: first participant recruitment performance of studies by study opening to recruitment month

Study opening to recruitment month	Percentage of studies that recruited their first participant within 30 days of opening to recruitment	Number of studies that recruited their first participant within 30 days of opening to recruitment	Number of studies that recruited a first participant	Number of open studies that have not yet recruited a first participant, or have not recorded doing so
October 2024	51%	32	63	16
November 2024	49%	31	63	14
December 2024	49%	25	51	13
January 2025	51%	28	55	15
February 2025	50%	43	86	19
March 2025	50%	27	54	19
April 2025	53%	33	62	20
May 2025	58%	46	79	15
June 2025	58%	33	57	17
July 2025	42%	24	57	26
August 2025	57%	31	54	21
September 2025	62%	52	84	26

Table 4.3: first participant recruitment performance of studies by study opening to recruitment year

Study opening to recruitment year	Percentage of studies that recruited their first participant within 30 days of opening to recruitment	Number of studies that recruited their first participant within 30 days of opening to recruitment	Number of studies that recruited a first participant	Number of open studies that have not yet recruited a first participant, or have not recorded doing so
2017	61%	662	1,091	157
2018	62%	714	1,143	174
2019	63%	633	999	190
2020	56%	417	744	148
2021	56%	523	934	182
2022	53%	484	913	193
2023	51%	418	822	192
2024	51%	397	774	188

Figure 4.1: percentage of studies on the CPMS that recruited their first participant within 30 days of opening to recruitment

Figure 4.2: average number of days taken for studies on the CPMS to recruit their first participant from opening to recruitment

Figure 4.1 shows the percentage of commercial contract studies on the CPMS that recruited their first participant within 30 days of opening to recruitment per month.

Since 2017, the percentage of studies recruiting their first participant within 30 days has been consistently below the current KPI target of 90%.

Data on the average time taken for studies to recruit their first participant shows a similar trend, as seen in figure 4.2. Since 2017, the average number of days taken for studies to recruit their first participant has been consistently higher than 30 days.

Contracting and delivery

Indicator 5: proportion of open studies on track, delivering recruitment to time and target

This indicator measures the percentage of open studies in the UK on the CPMS that are delivering recruitment to time and target each month. It is designed to assess the efficiency and predictability of study delivery.

‘Time and target’ is a measure of whether a study’s recruitment is on track compared with expectation.

The target is for 80% of all studies to deliver recruitment to time and target.

There is a lag between activity taking place at a study site and data being entered. This means data reported for a particular month may not be completely up to date. The data is not updated retrospectively in future reports.

This indicator relates to table 5 in the data tables.

Table 5.1: percentage of studies recruiting to time and target in March 2026 by study type

Study type	Percentage of studies recruiting to time and target	Number of open studies
All	82%	4,264
Commercial contract	79%	1,125
Commercial collaborative	83%	359
Non-commercial	83%	2,780

Table 5.2: percentage of studies recruiting to time and target by month and study type

Month	All	Commercial contract	Commercial collaborative	Non-commercial
April 2025	84%	78%	86%	86%
May 2025	83%	77%	86%	85%
June 2025	82%	76%	86%	85%
July 2025	84%	77%	87%	86%
August 2025	83%	78%	85%	85%
September 2025	83%	79%	86%	85%
October 2025	83%	80%	83%	84%
November 2025	83%	80%	83%	84%
December 2025	83%	81%	83%	83%
January 2026	82%	80%	82%	83%
February 2026	83%	79%	83%	84%
March 2026	82%	79%	83%	83%

Figure 5.1: percentage of studies on the CPMS recruiting to time and target by month and study type

Figure 5.1 shows the percentage of open studies on the CPMS recruiting to time and target per month by study type.

Since July 2023, overall recruitment to time and target has improved, with the percentage of studies on the CPMS recruiting to time and target regularly meeting or exceeding the KPI target of 80% each month.

Recruitment to studies

Indicator 6: average monthly recruitment to clinical studies

This indicator measures the average (mean) number of participants recruited per month over the last 12 months to all studies in the UK that are held on the CPMS. It is designed to track the volume of clinical research activity taking place in the UK.

The data presents a 12-month rolling average to account for seasonality.

The pre-COVID-19 baseline has been calculated as the average monthly recruitment to studies between January 2016 and December 2019.

There is a lag between activity taking place at a study site and data being entered. This means the figures reported are subject to change. Data is updated retrospectively in future reports as further information becomes available.

This indicator relates to table 6a, 6b and 6c in the data tables.

Table 6.1: average number of participants recruited per month over the last 12 months as of January 2026 by study type

Study type	Average number of participants recruited per month over the last 12 months	Pre-COVID-19 baseline
All	86,151	69,200
Commercial contract	3,212	3,900
Commercial collaborative	6,497	7,500
Non-commercial	76,442	57,900

Table 6.2: average number of participants recruited per month by year and study type

Year	All	Commercial contract	Commercial collaborative	Non-commercial
2016	57,692	3,144	5,953	48,594
2017	68,688	4,529	5,964	58,194
2018	77,511	4,368	8,737	64,405
2019	72,970	3,358	9,235	60,377
2020	156,042	3,242	6,626	146,174
2021	150,748	2,915	9,320	138,513
2022	92,371	3,027	9,532	79,813
2023	92,853	10,221	9,858	72,774
2024	99,975	9,715	10,269	79,991
2025	86,150	3,212	6,497	76,442

Figure 6.1: number of participants recruited to studies on the CPMS by month and study type

Figure 6.2: number of participants recruited to commercial contract studies on the CPMS by month and study type

Figure 6.1 shows the number of participants recruited per month to studies on the CPMS since 2016 by study type.

Figure 6.2 shows the same data but only for commercial contract studies, to present the detail.

Since 2016, most recruitment to studies on the CPMS has been to non-commercial studies.

There was a significant increase in recruitment to non-commercial studies and a slight drop in recruitment to commercial contract studies between 2020 and 2022, as the clinical research delivery system re-prioritised its resources to respond to the COVID-19 pandemic.

Participation in commercial contract studies increased significantly in 2023 and 2024, primarily due to increased recruitment to several very large observational studies.

Commercial contract studies recruit, on average, fewer participants per study than non-commercial studies. This is probably due to them comprising a higher proportion of more complex, interventional studies.

Volume of studies

Indicator 7: number of new studies added to the NIHR RDN portfolio

This indicator measures the number of new studies added on the CPMS portfolio. There is currently no target set for this indicator.

This indicator relates to tables 7a, 7b and 7c in the data tables.

Table 7.1: number of new studies added to CPMS in February 2026 broken down by study type.

Study type	Number of new studies added to CPMS
All	154
Commercial contract	68
Commercial collaborative	9
Non-commercial	77

Table 7.2: number of new studies added to the CPMS by month and study type

Month	All	Commercial contract	Commercial collaborative	Non-commercial
March 2025	147	50	14	83
April 2025	132	51	3	78
May 2025	161	59	10	92
June 2025	164	71	7	86
July 2025	210	84	9	117
August 2025	167	70	6	91
September 2025	187	72	10	105
October 2025	143	59	6	78
November 2025	131	51	10	70
December 2025	117	41	6	70
January 2026	148	62	6	80
February 2026	154	68	9	77

Table 7.3: number of new studies added to the CPMS by year and study type

Year	All	Commercial contract	Commercial collaborative	Non-commercial
2016	2,076	651	196	1,229
2017	2,312	668	260	1,384
2018	2,440	665	286	1,489
2019	2,246	630	254	1,362
2020	1,771	569	196	1,006
2021	2,190	713	207	1,270
2022	2,021	738	156	1,127
2023	2,002	744	157	1,101
2024	1,856	697	118	1,041
2025	1,852	709	104	1,039

Figure 7.1: number of new studies added to the CPMS by month and study type

Figure 7.1 shows the number of new studies added to the CPMS per month since 2016 by study type.

Since 2016, approximately one-third of new studies added to the CPMS have been commercial contract studies.

The number of new studies added to the CPMS has been stable across time.