150 Days Target for Study Setup in NHS Scotland
What are the current study setup targets for Scottish NHS sites?
- Studies taking place in Scotland should aim to recruit in 150 calendar days or less from IRAS application
- Local review should take 60 days or less, from either NRS approval or site selection to R&D approval
- Recruitment should take 30 days or less after the sponsor has given the go ahead to begin recruitment and the site is ready to start (“regulatory green light”)
- These targets currently apply only to commercially sponsored studies
Why are these targets being set?
There has been UK wide agreement that studies should aim to recruit the first UK patient within 150 days of IRAS submission. This is designed to meet industry expectations around study startup, and to make the UK internationally competitive for the placement and delivery of studies.
The NHS Research Scotland (NRS) Management Board, which includes the NHS Research & Development (R&D) Directors, recognise that industry will use this metric to select and place studies, so it is important to ensure that Scotland can demonstrate that Scottish sites can perform and deliver within these timelines.
They have agreed that the time for Scottish sites to setup and recruit should be 150 days or less. The aim is to ensure that Scotland remains competitive with other UK sites.
Sponsors may carry out their own measurements, which are likely to use automated in-house data, as well as looking at NHS published data.
Scottish sites will be assessed by sponsors against these targets, and decisions on Scottish and site placement will be expected to be made using data on site setup.
How are these targets being used?
The study wide review (SWR) phase incudes assessments from Research Ethics Committee (REC), Medicines and Healthcare products Regulatory Agency (MHRA) and UK Approval (NRS Approval, including SWR and Health Research Authority (HRA) / Health and Care Research Wales (HCRW) review where applicable). These are managed separately from site setup, and sites and are not directly responsible for Sponsor activities, although there is scope for supporting and assisting sponsors during this stage.
Site setup activities are expected to start well in advance of NRS approval wherever possible, and proceed in parallel with the multisite review.
Site setup is measured from when a site has been told it is taking part, or from the date of NRS Approval if that is later, to when R&D approval is issued. The UK target is 90 days, made up of separate periods of 60 days from site selection to R&D Approval, and 30 days from the sponsor approval to begin recruitment (RGL) to first patient.
In this context, first patient is measured as the first consented patient visit, whether or not the patient passes any applicable screening and enters the study.
Chief Scientist Office (CSO) financial allocations to Boards are not changed. CSO allocations continue to be based on consented patients counting towards study sample size. R&D funding allocations do not currently consider NHS Board performance against either the 150-, 60-, or 30-day targets. English sites use different models and incentives.
How is data gathered and reported?
The NRS Central Management Team (CMT) are working with the NRS Digital Improvement Group (N-DIG) to agree and update any changes to the way data is collected and reported in Scotland. Any changes, including national SOPs or guidance documents, will be subject to approval at the NRS Operations Group, which includes NHS R&D Senior Managers.
NHS R&D/I (Innovation) staff should continue to update ReDA and any other systems as needed and make sure that they are aware of relevant NRS guidance.
Study setup and approval should be delivered rapidly, and in parallel as far as possible to meet the agreed timeline.
CMT make Scottish data available to the National Institute for Health and Care Research (NIHR), who collate this information for the UK. The NIHR then work with the English Department of Health and Social Care (DHSC) to publish reports on UK-wide activity.
Where can I find out more?
CMT provide a national dashboard for Boards to track setup performance and for reporting to NRS Operations Group. These are reviewed monthly, and national reports on progress
will be made available to the NRS Management Board every quarter. If you need access, then please contact NRS Enquiries.
UK national datasets are regularly published in the UK Clinical Research Delivery (CRD) performance indicators report.
Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) data is used within the Commercial Research Delivery Centre (CRDC) UK Network
Industry have access to published data and may derive their own performance metrics internally.
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