A new measure from NIHR CRN for ‘Study Set Up’

Date: 20 September 2019

To ensure that the NIHR CRN continues to focus on improving performance and reducing the time taken for study site set-up for NIHR CRN Portfolio studies a new HLO will be introduced in 2019/20 which will measure and aim to reduce the intra-study variability in set up times.

The CRN CC undertook a “review and refresh” of the HLOs as part of its Annual Business Plan for 2018/19. This project included an extensive survey to elicit the views of LCRN Partnership Group members, LCRN Host Organisations, LCRN Patients and Public Involvement and Engagement (PPIE) Leads, and CRN National Specialty Leads. Over 400 individuals participated in the consultation.  The proposal to DHSC was to retain most current HLOs, with some changes in wording for clarity, and to withdraw some HLOs.

The HLOs proposed for withdrawal were:

• HLO 4 – Reduce the time taken for eligible studies to achieve set up in the NHS
• HLO 5 – Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies.DHSC accepted other changes but advised that it was not content for the removal of the above HLOs and that CRN CC should reconsider their withdrawal.  A new proposal was drawn up, put forward and agreed.

From April 2019, HLO 4 & 5, are no longer being reported.  A new NIHR CRN measure will focus on reducing the time taken for study site set up from “Date Site Selected” to “Date First Participant Recruited” at each site. These data points were used to calculate previous HLOs are available as part of minimum data set in CPMS/LPMS.

This will now be identified as HLO 9.  This metric will allow CRN CC to determine the level of impact NIHR CRN has on this ‘combined measure’ of consistency of study start up, including recruitment of the first participant at site.

For 2019/20, a new introductory target of a 5% reduction was introduced and a national medianaverage time for study set up based on figures for set-up performance in FY 2018/19.   This means that LCRNs will be expected to, focus on intra-study variabilityin 2019/20, and meeting the national targets.

Dr Sharon Barrett (CRN CC Head of Feasibility and Start Up) stated; “In real terms, what we are aiming for is to acknowledge the sites who are in a position to set studies up and recruit the first patient in a timely fashion but also the sharing of best practice to allow other sites across the country to mitigate any challenges which may arise at their respective sites during set up” (see figure)

Data gathered by LPMS’s will capture both study and site level to allow LCRNs to performance manage their respective partner organisations in improving performance. This will happen alongside the PID reporting that is expected for NHS organisations.

Contact: Sharon Barrett (Head of Feasibility and Start Up) sharon.barrett@nihr.ac.uk

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