Official Statistics

UK clinical research delivery key performance indicators: methodology note

Published 17 December 2025

Introduction

This methodology note accompanies the UK clinical research delivery (UKCRD) key performance indicators (KPIs) report, published for the first time 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 note 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 note are numbered and are referred to by their numbers throughout the note.

Table 1: indicator descriptions

Indicator number	Indicator description
1	Proportion of studies receiving combined review approval within 60 days (or 90 days for ATIMP studies)
2	Proportion of commercial contract studies opening to recruitment within 60 days of Health Research Authority (HRA) approval letter or equivalent process used by the devolved governments
3	Proportion of commercial contract studies recruiting first participant within 30 days of opening to recruitment
4	Proportion of NHS trusts in England who accept the local price generated as part of the NCVR process for late-phase commercial contract studies without further negotiation, following agreement of the resource required by the lead site
5	Proportion of open studies on track, delivering recruitment to time and target
6	Average monthly recruitment to all studies is maintained at high levels when compared to the pre-pandemic baseline
7	Average monthly recruitment to all commercial contract studies to be monitored in support of the ambition to double and double again from the pre-pandemic baseline
8	Proportion of studies open to recruitment or suspended
9	Be Part of Research monthly registrations

Data sources

The data for indicator 1 is provided by the Medicines and Healthcare products Regulatory Agency (MHRA) and the data for indicators 2 to 9 is provided by the National Institute for Health and Care Research (NIHR).

Except for indicators 1, 4 and 9, all UKCRD key performance indicators (KPIs) measure performance or levels of recruitment for studies held on the NIHR Research Delivery Network’s (RDN) 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. A 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. They do 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 whole 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 (UKRI)

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

• interventional studies are 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 are studies in which the investigators do not seek to intervene but simply observe the course of events

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. For indicators that are reported UK-wide now, they may not have been in the past. Key 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	United Kingdom	The indicator includes initial clinical trial authorisation applications from studies across the UK
2 and 3	United Kingdom	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
4	England	The indicator reports on the performance of NHS trusts in England
5	United Kingdom	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 and 7	United Kingdom	The indicators report on recruitment to studies in the UK that are held on the CPMS
8	United Kingdom	The indicator reports on the performance of studies in the UK that are held on the CPMS
9	United Kingdom	The indicator reports on the number of participants in the UK who have registered with the Be Part of Research service

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	June 2024 onwards
2 and 3	January 2017 onwards
4	Not applicable - see details section
5	July 2023 onwards
6 and 7	January 2016 onwards
8	January 2016 onwards
9	June 2022 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 2 and 3, and 5 to 8, 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 is 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 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 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 a research ethics committee (REC).

The clock starts on the date an initial clinical trial authorisation application is submitted to the Integrated Research Approval 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 the 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 the separate statutory requirements for MHRA and HRA. MHRA publish performance data related to their statutory requirements.

Indicator 2: proportion of commercial contract 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 commercial contract 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 commercial contract 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 3: proportion of commercial contract studies recruiting first participant within 30 days of opening to recruitment

Data collection, processing and presentation

This indicator measures the percentage of commercial contract 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 commercial contract 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, are 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 4: proportion of NHS trusts in England who accept the local price generated as part of the NCVR process for late-phase commercial contract studies without further negotiation following agreement of the resource required by the lead site

Data collection, processing and presentation

National contract value review (NCVR) is the UK-wide, standardised approach to costing for commercial contract research taking place in NHS organisations.

This indicator shows the percentage of NHS trusts in England who accept the local price generated by the interactive costing tool as part of the NCVR process for late-phase commercial contract studies, without further negotiation, following agreement of the resource required by the lead site.

The target is for 100% of NHS trusts in England to accept the local price generated as part of the NCVR process for late-phase commercial contract studies. This target has been achieved. The aim now is to maintain this performance as all phases of commercial contract research are brought into the process.

This indicator is no longer updated as it has been achieved and will not regress. Only a single data point is presented in this report.

Limitations and caveats

This indicator specifically shows the percentage of NHS trusts in England who accept the local price generated as part of the NCVR process for late-phase commercial contract studies. It does not show the percentage of NHS trusts who accept the local price generated as part of the NCVR process for other phases of commercial contract research.

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 the 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 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 all studies is maintained at high levels when compared to the pre-pandemic baseline

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: average monthly recruitment to all commercial contract studies to be monitored in support of the ambition to double and double again from the pre-pandemic baseline

Data collection, processing and presentation

This indicator measures the average (mean) number of participants recruited per month over the last 12 months to commercial contract studies in the UK that are held on the CPMS. It is designed to track the volume of commercial contact 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.

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

The pre-COVID-19 baselines for each study type have been calculated as the average monthly recruitment to studies between January 2016 and December 2019. The breakdowns may not add up to the main baseline due to rounding.

NIHR supplies 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, are 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 8: proportion of studies open to recruitment or suspended

Data collection, processing and presentation

This indicator measures the percentage of studies in the UK on the CPMS that are classed as either open or suspended each month.

The aim is for approximately 80% of all studies on the CPMS to be classed as open or suspended each month, with no more than approximately 20% of studies classed as in set-up.

Data broken down by study type is presented in both the UKCRD KPIs report and in additional data tables published alongside the report. Data on the number of new studies added to the CPMS is also presented.

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 data reported for a particular month may not be completely up to date.

Data on the percentage of studies that are classed as either open or suspended each month is not updated retrospectively in future reports. Data on the number of new studies added to the CPMS is updated retrospectively as further information becomes available.

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.

Indicator 9: Be Part of Research monthly registrations

Data collection, processing and presentation

This indicator reports the number of participants in the UK who have registered with the Be Part of Research (BPoR) service.

BPoR is an online platform provided by NIHR to promote participation in health and social care research. The service enables users to search for relevant studies and register their interest, making it easier for people to find and take part in health and care research that is relevant to them.

NIHR provides data monthly, with data reported from June 2022 onwards.

Limitations and caveats

There is a lag between information entered by participants and data being collated for the report. This means that figures reported for recent months may be incomplete, and figures for all months are subject to change. Data is updated retrospectively in future reports as further information becomes available.

Data pre-dating spring 2024 is attributed to the start of registration, rather than the end of registration. As a result, some registrations have been assigned to the incorrect month for this period. This issue has now been resolved.

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

We welcome feedback from users to help us improve the content, relevance and presentation of future releases. We are particularly interested in hearing your views at this early stage.

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