Study Set-Up

Trust level set up report

Published 28th April 2025

Purpose

This report will be published each month starting in April 2025 alongside the UK Clinical Research Delivery Key Performance Indicator Report (KPI) to provide an additional monthly snapshot of site-level commercial study set-up performance. The aim of this report is to take initial steps in improving granularity of study set-up activity to support closer to real time monitoring of system performance.

We are introducing this interim report as part of the transition to a real-time data dashboard to complement the Research Delivery Data and Intelligence (RDDI) Programme. The RDDI Programme has been established to address many of the challenges with the collection of clinical research delivery data, including data on study set-up.

Currently, this report includes data from England sites only. We are working with system partners across the devolved nations to align improvements and will incorporate additional insights to this report as new data becomes available.

Background

Clinical research is key to the vision of building a health and social care system fit for the future and to drive economic growth for this country, as laid out in the Health and Growth missions of the government. Research has already driven widespread improvements in care and outcomes for patients and the public and will continue to be a pivotal part of reform plans, together with supporting the wider life sciences sector via innovation and investment.

All four UK nations are fully committed to working with partners across the clinical delivery system via the UK Clinical Research Delivery (UKCRD) programme to make the UK a world leader in clinical research. To achieve this, the Prime Minister has stated that we will turbo-charge medical research and deliver better patient care by accelerating clinical trial set-up and cutting bureaucracy.

We would like to increase visibility and transparency of our research portfolio by enhancing the data we already publish monthly via the UK KPI Report. The first step of this work is to publish this report to enhance the two current study set-up KPIs, at a site-level:

Proportion of commercial contract studies open to recruitment within 60 days of HRA approval letter
Proportion of commercial contract studies recruiting first participant within 30 days of sites opening to recruitment

Click here to view previous monthly reports.

Data Source

This report uses data collected for commercial contract studies on the NIHR Research Delivery Network (RDN) Portfolio (for England sites only), captured through the NIHR’s RDN’s Central Portfolio Management System (CPMS). Commercial contract studies are defined as studies sponsored and fully funded by the life sciences industry. The indicators include data for both interventional and observational commercial studies.

To give sites enough time to reach and record endpoints for these indicators (60 or 30 days), a 4 month reporting lag will be applied to this monthly report, allowing sufficient time for these timepoints to elapse and for sites to record them in the LPMS.

To ensure NIHR RDN are able to effectively monitor the national portfolio, and in line with DHSC’s Terms and Conditions for NIHR RDN support, NIHR RDN require reporting of activity data on via Local Portfolio Management Systems (LPMSs) provided by each RRDN. This data feeds into RDN’s Central Portfolio Management System (CPMS) from which national reports are generated. These systems have been employed to gather the additional data points required for visibility of site-level set-up times, utilising existing fields and data definitions.

Data Quality and Limitations

To enable site-level reporting of this data, DHSC and NHS England issued a formal requirement in March 2025 for NHS Trusts in England to provide additional data for commercial contract studies (from 1st December 2024 onwards) on the NIHR RDN Portfolio. The requirement includes sites to update two fields that are essential to linking site participation to studies within NIHR CPMS and monitoring progress.

We are aware that there are instances in which the study sponsor does not wish to open a site to recruitment within the 60-day timeline e.g. not included in the first wave of site activation. These studies are still included in the data and will impact on the indicator, we will continue to work with system partners to assess how best to refine this data as this report develops.

Method

Indicator: Proportion of commercial contract studies open to recruitment within 60 days of HRA approval letter

For each month, this indicator is calculated by collating all the commercial contract studies at each site held on the CPMS that received HRA approval in that given month, where the site has indicated participation, and then calculating what proportion of these studies then opened to recruitment within 60 days of HRA approval.
The start point is the date a study receives HRA approval. HRA provides NIHR RDN with this data each month.
The end point is the date the site is ready to start recruitment. This date is entered into Date Site Ready to Start field in the LPMS.
The median number of days from HRA approval to date site ready to start is calculated by determining the middle value in the data set for each site. It only includes studies that have recorded both their start and end points in the system.

Indicator: Proportion of commercial contract studies recruiting first participant within 30 days of sites opening to recruitment

For each month, this indicator is calculated by collating all the commercial contract studies at each site on the CPMS that were ready to start in that month (where the site has indicated participation) and then calculating what proportion of these studies recruited within 30 days of being ready to start.
The start point is the date entered into ‘Date Site Ready to Start’ field in the LPMS.
The end point is the date entered into ‘First Patient First Visit Date field in the LPMS.
The median number of dates from date site ready to start to first participant recruited is calculated by determining the middle value in the data set for each site. It only includes studies that have recorded their start and end points in the system.

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