Guidance

UK Clinical Research Delivery key performance indicators: methodology

Updated 15 April 2026

Introduction

This methodology accompanies the UK Clinical Research Delivery (UKCRD) programme key performance indicators (KPIs) report, published on GOV.UK by the Department of Health and Social Care (DHSC). It provides detailed information on the data sources, collection and reporting methods and quality assurance procedures used to produce the statistics.

The aim of this methodology is to help users understand how the statistics were compiled, the quality and scope of the data reported, and how the data can be used. It is intended for users who wish to understand the technical aspects of the publication.

The statistics in this release are produced in accordance with the UK Statistics Authority’s Code of Practice for Statistics, ensuring they meet the standards of trustworthiness, quality and value. They are published as official statistics in development.

The indicators described in this methodology are numbered and are referred to by their numbers throughout.

Table 1: indicator descriptions

Indicator number	Indicator description
1	Proportion of commercial contract clinical trial of investigational medicinal products (CTIMP) studies recruiting first participant within 150 days of applying for regulatory approval
2	Proportion of studies receiving combined review approval within 60 days (or 90 days for advanced therapy investigational medicinal product (ATIMP) studies)
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
4	Proportion of studies recruiting first participant within 30 days of opening to recruitment
5	Proportion of open studies on track, delivering recruitment to time and target
6	Average monthly recruitment to all clinical studies
7	Number of new studies added to the National Institute for Health and Care Research (NIHR) Research Delivery Network (RDN) portfolio

Changes to indicators

In April 2026 the indicators were updated to:

• remove completed indicators
• add new indicators
• increase the scope of other indicators

Indicator 1 measures the proportion of commercial contract CTIMP studies recruiting their first participant within 150 days of applying for regulatory approval. This is a new indicator published as of April 2026.

Indicator 2 measures the proportion of studies receiving combined review approval within 60 days (or 90 days for ATIMP studies). This is not a new measure but was presented as indicator 1 up until March 2026.

Indicators 3 and 4 measure the proportions of studies opening to recruitment within 60 days of regulatory approval and recruiting a first participant within 30 days of opening to recruitment respectively, with the targets applying to all study types. They are similar to the indicators 2 and 3 published previously, but those applied only to commercial contract studies, whereas these apply to all studies.

Indicator 4 previously measured the proportion of NHS trusts in England that accept the local price generated as part of the national contract value review (NCVR) process for late-phase commercial contract studies. This target was achieved and is no longer tracked.

Indicator 5 is unchanged since the first publication.

Indicator 6 measures recruitment to all studies. Previously, an additional indicator (7) separately measured recruitment to commercial contract studies. This indicator has been removed. A breakdown of recruitment by study type, including for commercial contract studies, is reported under indicator 6 and in its accompanying data tables.

Indicator 7 now measures the number of new studies added to the NIHR RDN portfolio. It replaces indicator 8, which measured the proportion of portfolio studies that were open to recruitment or suspended. This measure has been removed because it did not provide a clear view of the health of the study pipeline.

We no longer publish indicator 9 (Be Part of Research monthly registrations). This will be published separately by NIHR.

Data sources

Data for indicators 1 and 3 to 7 is provided by NIHR. Data for indicator 2 is provided by the Medicines and Healthcare products Regulatory Agency (MHRA).

Except for indicator 2, all UKCRD KPIs measure performance or levels of recruitment for studies held on NIHR RDN’s Central Portfolio Management System (CPMS).

Study data in the CPMS is either entered directly into the system by sponsors or is recorded in a local portfolio management system (LPMS) by research staff. An LPMS is used within NHS organisations, such as hospital trusts, to record and manage information about research studies taking place locally, with the information then shared with the CPMS.

Data coverage

The data is measuring 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. It is unknown what proportion of studies in the UK the CPMS represents.

The CPMS is a national database used to record and manage study information. It includes studies in England that are part of the RDN Portfolio, as well as studies from the devolved governments that are either part of the RDN Portfolio or uploaded as non-portfolio studies. The RDN Portfolio is made up of research studies eligible for support from NIHR RDN in England.

The scope and remit of RDN and its previous iterations have changed over time, as have the ways in which data has been collected and studies classified. Caution should be taken when making comparisons of CPMS data across time.

Data from commercial private sites is not captured in the CPMS, nor is it accounted for in the indicators.

Data from the CPMS cannot be used to report on the performance or activity of the entire clinical research system in the UK.

Study type classification

Data is categorised into 3 distinct clinical research study types, as follows:

• 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 are supported in the same way as non-commercial studies, including provision of support costs and excess treatment costs through the NIHR RDN and 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.

In the supplementary data tables, studies are further categorised as interventional and observational studies, as follows:

• interventional studies: studies in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol and participants may receive diagnostic, therapeutic or other types of interventions
• observational studies: studies in which the investigators do not seek to intervene but simply observe the course of events

Indicator 1 reports specifically on the delivery of CTIMPs. CTIMPs are a type of interventional study that investigate the effects of products such as medicines or drugs. They do not cover other interventions such as medical devices.

To note, commercial collaborative studies were previously included under the non-commercial category but are now disaggregated to more accurately reflect the scope of commercial research activity. However, not all past commercial collaborative studies will have been reviewed retrospectively and re-classified, particularly studies that had already closed. From the 2023 to 2024 financial year onwards, data for the commercial collaborative category is more robust, due to data quality improvements linked to reporting this category separately.

Geographies

Although the indicators apply UK-wide, the reporting of several of them does not currently include complete data from all 4 nations. Indicators that are reported UK-wide now may not have been in the past. Details of the geographical coverage of each indicator are provided in the table below. Work is ongoing with devolved governments to bring their data into this reporting.

Table 2: geographical coverage of indicators

Indicator	Geographic coverage	Notes
1	UK	The indicators are intended to apply UK-wide and currently report on the performance of studies in England and, so far as is possible, the devolved governments, that are held on the CPMS. Work is ongoing to incorporate further data from devolved governments
2	UK	The indicator includes initial clinical trial authorisation applications from studies across the UK
3 and 4	UK	The indicators are intended to apply UK-wide and currently report on the performance of studies in England and, so far as is possible, the devolved governments, that are held on the CPMS. Work is ongoing to incorporate further data from devolved governments
5	UK	Up until October 2025, the indicator measured the performance of studies held on the CPMS using data from English sites only. Since November 2025, it has included data from sites in the devolved governments to report UK-wide performance of studies held on the CPMS
6	UK	The indicators report on recruitment to studies in the UK that are held on the CPMS
7	UK	The indicator reports on the performance of studies in the UK that are held on the CPMS

Time period

The period presented varies by indicator and depends on when complete data became available.

For some indicators, policy expectations, targets and data entry requirements have changed during the periods covered in this report. Some data included here pre-dates the implementation of the current UKCRD KPIs in January 2024.

Table 3: time periods of indicators

Indicator	Time period covered
1	April 2025 onwards
2	June 2024 onwards
3	January 2017 onwards
4	January 2017 onwards
5	July 2023 onwards
6	January 2016 onwards
7	January 2016 onwards

Data quality

These statistics are based on manually entered operational data. This means some errors may occur. Checks are carried out to reduce these where possible. This is currently the best source of information available to provide insights into clinical research delivery performance in the UK.

For indicators 1 and 3 to 7, the quality of the data reported is dependent on the accuracy, timeliness and completeness of its entry into the CPMS and LPMSs 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.

Quality assurance

The CPMS is designed to prevent the reporting of erroneous data wherever possible. Checks are in place to identify and exclude problematic data, such as misaligned data (for example, endpoints occurring before start points). Null values are identified and addressed during the data validation process. Discrepancies or missing data (for example, missing opening dates) are flagged and communicated to sponsors or data owners for resolution.

Details of indicators

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

Data collection, processing and presentation

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 of 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.

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 research ethics committee (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, which for interventional trials is defined as the date of the first study visit of the first participant as set out in the study protocol.

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. 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 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 (that is, 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. See ‘Sponsor intelligence’ below.

The indicator applies to commercial contract CTIMP studies only. Work is ongoing to be able to apply the indicator to a broader range of studies in the future.

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

Limitations and caveats

The indicator is intended to apply UK-wide and currently includes data from studies in England and, so far as is possible, the devolved governments. Work is ongoing to incorporate further data from devolved governments.

The latest time period reported is 6 months before the report’s publication month. This is to allow sufficient time for most studies to be set up within 150 days and data entered. Figures for all months are subject to change and will be revised in future reports as more information becomes available.

Sponsor intelligence

To produce timely results that are sufficiently complete and accurate for measuring performance against the 150-day target, NIHR carried out additional assurance by gathering sponsor intelligence. Where a study was missing data, they contacted the relevant sponsor to get the latest status of the study.

Establishing whether a study was set up within 150 days is based on both CPMS data and sponsor intelligence. If either source indicates that the target was met (‘Yes’), the final outcome is ‘Yes’.

If neither source records ‘Yes’ but at least one source records that the target was not met (‘No’), the final outcome is ‘No’.

The final outcome is ‘Unknown’ only when both sources are missing, unknown, or otherwise indeterminate.

Table 4 summarises this logic.

Table 4: recording of target met by result in CPMS data and result in sponsor intelligence

	‘Yes’ in sponsor intelligence	‘No’ in sponsor intelligence	‘Unknown’ in sponsor intelligence
‘Yes’ in CPMS	Yes	Yes	Yes
Possible ‘no’ in CPMS	Yes	No	No
‘Unknown’ in CPMS	Yes	No	Unknown

This approach ensures that confirmed evidence of meeting the target is not overridden by missing or incomplete information, while still distinguishing between studies that did not meet the target and studies because of insufficient information. CPMS can only provide a complete picture once all delivery sites have entered their data into local systems, whereas sponsors have a continuous view across all activity related to delivering their study.

When first published, the percentage of studies being set up within 150 days was 2 percentage points lower than when just using CPMS data.

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

Data collection, processing and presentation

This indicator measures the percentage of approved initial clinical trial authorisation applications in the UK each month that received their combined review decision within 60 calendar days, or within 90 days for advanced therapy investigational medicinal products (ATIMPs), of regulatory submission. 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 an REC.

The clock starts on the date an initial clinical trial authorisation application is submitted to the Integrated Research Approval System. If the applicant chose 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 indicator is calculated by grouping all the studies by the month they received combined review approval, then determining what percentage of these achieved this within 60 days (or 90 days for ATIMP studies).

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).

MHRA provides data monthly, with data reported from June 2024 onwards.

Limitations and caveats

The indicator does not include studies that did not receive combined review approval.

The way DHSC measures combined review as part of the UKCRD KPIs is different from the way it is measured as part of separate statutory requirements for MHRA and HRA. MHRA publishes performance data related to their statutory requirements.

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

Data collection, processing and presentation

This indicator measures the percentage of studies in the UK 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.

The indicator is calculated by grouping all the studies by the month they received regulatory approval, then determining what percentage of those that opened to recruitment did so within 60 days.

Only studies that have recorded opening to recruitment are included in the indicator calculation. Studies that have not yet opened to recruitment, or have not recorded doing so, are excluded from the calculation. These studies are reported separately in the tables for transparency.

Studies that have not recorded their HRA approval date in the system are not included in the data. Studies that have recorded a study opening date earlier than their HRA approval date are removed.

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

Data on the average number of days taken for studies to open to recruitment and data broken down by further study types, is presented in both the UKCRD KPIs report and in the additional data tables published alongside the report.

NIHR provides data monthly, with data reported from 2017 onwards.

Limitations and caveats

The indicator is intended to apply UK-wide and currently includes data from studies in England and, so far as is possible, the devolved governments. Work is ongoing to incorporate further data from devolved governments.

The latest time period reported is 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. At this point, a more complete picture is available, though changes may continue to occur. Figures for all months are subject to change and will be revised in future reports as more information becomes available.

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

Data collection, processing and presentation

This indicator measures the percentage of studies in the UK 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.

The indicator is calculated by grouping all the studies by the month they opened to recruitment, then determining what percentage of those that recruited their first participant did so within 30 days.

Only studies that have reported recruiting their first participant are included in the indicator calculation. Studies that have not yet recruited their first participant, or have not recorded doing so, are excluded from the calculation. These studies are reported separately in the tables for transparency.

Studies that have not recorded their study opening date in the system are not included. Studies that record a first participant recruitment date earlier than their study opening date are removed.

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.

Data on the average number of calendar days taken for studies to open to recruitment and data broken down by further study types, is presented in both the UKCRD KPIs report and in additional data tables published alongside the report.

NIHR provides data monthly, with data reported from 2017 onwards.

Limitations and caveats

The indicator is intended to apply UK-wide and currently includes data from studies and sites in England and, so far as is possible, the devolved governments. Work is ongoing to incorporate further data from devolved governments.

The latest time period reported is 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. At this point, a more complete picture is available, though changes may continue to occur. Figures for all months are subject to change and will be revised in future reports as more information becomes available.

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

Data collection, processing and presentation

This indicator measures the percentage of open studies in the UK on the CPMS that are delivering recruitment to time and target each month.

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

It is calculated using CPMS data and sponsor feedback. Data from the CPMS is used to make an initial assessment to determine whether a study’s recruitment is on track or not. Studies that have fallen significantly below expectations are flagged to sponsors to review on a quarterly basis. Sponsors can then provide their assessment of whether a study is on track or not, using NIHR’s Sponsor Engagement Tool.

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

Data broken down by study type is presented in both the UKCRD KPIs report and in additional data tables published alongside the report.

NIHR provides data monthly, with data reported from July 2023 onwards.

Limitations and caveats

Up until October 2025, this indicator measured the performance of studies using data from English sites only, with the exception of data for December 2023, which reported the performance of studies using data from UK sites. Since November 2025, this indicator has included data from sites in the devolved governments to report UK-wide performance.

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.

Indicator 6: average monthly recruitment to clinical studies

Data collection, processing and presentation

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 average monthly recruitment is calculated using data from the most recent 12 months.

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

NIHR provides data monthly, with data reported from 2016 onwards.

Limitations and caveats

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, including the baseline calculation, is updated retrospectively in future reports as further information becomes available.

The balance between observational studies and interventional ones on the RDN Portfolio will influence recruitment figures, making it difficult to compare data across years. For example, the presence in the portfolio of very large sample size observational studies can significantly increase recruitment numbers at particular points in time.

Not all recruitment data from devolved government portfolios has been uploaded to the CPMS. The volume of missing data is limited and does not significantly impact on the overall presentation of the data.

Indicator 7: number of new studies added to the CPMS portfolio

Data collection, processing and presentation

This indicator measures the number of new studies added to the CPMS portfolio each month.

Data broken down by study type is presented in both the UKCRD KPI report and in additional data tables published alongside the report.

NIHR provides data monthly, with data reported from 2016 onwards.

Limitations and caveats

Data on the number of new studies added to the CPMS is updated retrospectively as further information becomes available. Studies are removed from the indicator if they are withdrawn from the NIHR RDN Portfolio during the set-up phase and do not progress.

Not all study data from devolved government portfolios has been uploaded to the CPMS. The volume of missing data is limited and does not significantly impact on the overall presentation of the data.

Future improvements

This publication is currently classed as official statistics in development. How the data is collected and analysed will continue to be refined. In particular, we are yet to make a full assessment of the quality issues outlined in this note on the accuracy of the indicators. We will continue to improve the methods over time to make the statistics more accurate and useful. Any significant changes to methods or data sources will be clearly documented in future releases.

Contact details

If you have any feedback or questions, contact statistics@dhsc.gov.uk.