Streamlining and reforming the set-up and delivery of all clinical trials is key to driving global investment into life sciences, improving health outcomes and accelerating the development of medicines and therapies of the future.  This shared ambition requires a sustained system-wide effort for the benefit of patients, the NHS and the wider economy.

As announced by the Prime Minister in April 2025, the UK government is committed to reducing the time it takes to get a clinical trial set up from over 250 days, down to 150 days, by March 2026. This commitment is a headline action of the recently published  Life Sciences Sector Plan and is reinforced in the 10 Year Health Plan for England.

The Department of Health and Social Care (DHSC), through the UK Clinical Research Delivery Programme (UKCRD) has led a four-nation Study Set-Up Plan to achieve system level improvements to clinical research delivery.  The Plan was completed in two phases, with phase 1 deliverables published in April 2025 and phase 2 deliverables published in June 2025.  It remains vital that policies and guidance set out in the Plan are embedded and implemented effectively and that data around clinical trial set-up and meeting the 150-day commitment is recorded and captured effectively and as close to real-time as possible of the activities being completed.

How are we measuring progress towards the government’s target?

We are now closely tracking the performance of all studies held on the National Institute for Health & Care Research (NIHR) Research Delivery Network (RDN) Central Portfolio Management System (CPMS) for the purpose of a metric that measures the entirety of a study’s set-up journey against the government’s 150-day target.

The 150-day metric measures the time taken in calendar days for a single study from application for regulatory approval through to recruitment of first study participant.

It comprises three distinct stages of study set-up:

• 1. Time taken for the Medicines & Healthcare products Regulatory Agency and Research Ethics Committee to deliver a combined review decision - target is 60 days.

  2. Time from combined review decision to study opening - target is 60 days.

  3. Time from study opening to first participant recruited - target is 30 days.

The metric applies to all clinical trials, with a focus on commercial interventional clinical trials.

Excluded from the reporting are studies where the 150 day metric is not expected in the study milestone plan, such as rare disease and other low recruitment studies - using criteria that apply already in our UK Clinical Research Delivery Key Performance Indicators (UKCRD KPI) Report - and extension studies.

What does the 150-day metric mean for sites?

As part of this commitment to speed up the set-up of clinical trials, there is an accompanying policy expectation that all participating sites for a study must complete their set-up activities within 90 days. 

That is, sites in England must recruit their first participant for a study within 90-days of a study receiving regulatory approval, or the site being selected to take part, whichever comes later. We define the first participant recruited as ‘first participant, first visit’ in the table below.

This metric comprises two distinct stages of site set-up:

1. Time from regulatory approval (either Health Research Authority and Health and Care Research Wales [HRA and HCRW] approval, or suitable equivalent used by the other devolved governments) or date site selected, whichever comes later, to site opening - target is 60 days.

2. Time from site opening to first participant recruited - target is 30 days.

We strongly advise sites to begin set up processes as soon as possible in parallel to regulatory assessments to help them meet the target of setting up within 90 days.

To monitor site-level performance against the 90-day target, we will produce a separate site-level report, using data from studies held on the NIHR RDN CPMS.

What are the data entry requirements for sites in England?

To enable reporting of the performance of NHS trusts in England against the 90-day target, we require all sites to complete six existing data fields on their Local Portfolio Management System (LPMS) for each study they are involved in (where HRA and HCRW approval has been received for the study from 1 April 2025) as close to real time as possible of the activities being completed. 

The data fields that we require sites to complete are:

To note, only some of these data fields are required for the purpose of calculating the metric itself, but all six must be completed by sites, and completed chronologically as set out above, for their studies to be counted in the data. It is essential that sites provide accurate, timely and complete data in their LPMS, so that we can precisely monitor set-up performance. We will be updating the Department of Health and Social Care’s (DHSC) Terms and Conditions for NIHR RDN Support to include these data entry requirements as a condition of funding. The NIHR RDN will provide further information and support to sites on what the requirements are for entering data into their LPMS.

From April 2026, the RDN’s funding model in England will allocate 20% of delivery funding towards achieving a set of KPIs focused on reducing study-set up time and improving study delivery and driving growth. Delivery organisations that have met the 90-day target described above between 1 April 2025 and 31 December 2025 will receive performance-based recognition in their funding allocation for 26/27. Further performance-based recognition will be built into future funding cycles.

Enhancing the use of data to improve clinical research delivery in the UK

Improved recording of this data will also directly support enhanced reporting of the monthly UKCRD KPI report and the transition to a real-time data dashboard being delivered through the Research Delivery Data and Intelligence (RDDI) Programme. DHSC supports a data transparency agenda and work continues at pace to progress to real time data reporting.

We continue to work with system partners across the devolved governments to ensure UK compatibility and alignment with system performance and these reporting requirements.

For more information, or queries relating to the UKCRD Programme please contact UKCRDprogramme@dhsc.gov.uk 

For data related queries, please contact your local RRDN using the details here.