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150 days study set up target

 

The NIHR has established a number of workstreams to support the UK Government's commitment to reduce clinical trial set up times to 150-days or less. Updates on each of these is provided below and will be communicated on a regular basis to delivery organisations and sponsors.

In this update:

  • Data field guidance and dashboard updates
  • NIHR Industry Hub begins supporting studies
  • New 150-day website section coming soon

NIHR workstreams and support - latest updates

Data completeness 

The NIHR Research Delivery Network (RDN) is developing a technical guidance document to support delivery organisations to enter the mandated set-up data fields within their LPMSs, as per the DHSC Policy Statement. The RDN is aiming to release the first version of this guidance by the end of October. It will be sent directly to Regional RDNs (RRDNs) to share with delivery organisations.

Alongside this, the first version of the data dashboard for delivery organisations has been developed and will be launched early this week. Future developments to the delivery organisation dashboard will include:

  • data on performance elements of the funding model (end of October)
  • incorporating data quality, data integrity and data timeliness views (mid-November)

We will notify you in future bulletins as soon as they are available. 

Study-level offer

As outlined in last week’s update, we have identified an initial portfolio of commercial interventional studies from NIHR Key Account industry sponsors and contract research organisations (CROs)  that would benefit from  set-up support to help meet the 150-day study start-up target by March 2026. Additional studies will continue to be identified on a rolling basis as they receive combined HRA and MHRA approval, ensuring that the portfolio reflects all eligible commercial studies requiring targeted assistance. Progress will be monitored and reported weekly to maintain visibility of performance, provide timely escalation, and ensure that resources are directed to where they can deliver the greatest impact.

All identified studies are being referred to the NIHR Industry Hub, which is now fully operational and positioned to coordinate activity across the NIHR research delivery infrastructure. The Industry Hub has been established to strengthen collaboration between NIHR and industry, accelerating study set-up, contracting and recruitment while ensuring consistent, high-quality commercial trial delivery across NIHR and our devolved nation partners. It brings together RRDN Key Account Managers, colleagues from the NIHR RDN Coordinating Centre, and the team supporting the UK Vaccine Innovation Pathway. Working in partnership with the wider NIHR infrastructure - including Clinical Research Facilities, Commercial  Research Delivery Centres, Experimental Cancer Medicine Centres and the Devolved Administrations - the Hub provides an integrated framework for performance oversight and delivery acceleration.

Through this joined-up approach, the Industry Hub offers a single point of coordination for commercial research delivery across the UK. It provides system-wide visibility of study timelines, enables early identification of barriers and supports NHS  R&D departments to maintain momentum through the set-up and initiation stages. Delivery partners will be contacted by their regional RRDN or Industry Hub representative as studies progress through activation and early recruitment, ensuring collaborative communication and consistent support across the commercial research portfolio.

New 150-day website section and FAQs

In the next week, we will be launching a new section on the NIHR RDN website which will host key information around NIHR’s support for delivery organisations and studies.  

DHSC will soon publish FAQs providing detailed information on the policy statement. These should be your first reference for any policy-related queries and will have input from HRA, MHRA and NHSE.

NIHR have also started to collate questions relating to key operational issues affecting sites. If you have a question, please send it to RRDN@nihr.ac.uk and put ‘150 days’ in the subject line. 

These will be cross referenced with colleagues in DHSC to ensure consistency in messaging.

 

Contact us

If you have any local specific support requests or queries, contact NIHR for support via your NIHR Regional Research Delivery Network (RRDN).

You can find out more about the cross-sector work to improve study set-up, including the 150 day target, on the UK Clinical Research Delivery programme website.