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Research & Development

Performance in Initiating and Delivering Clinical Research

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. The aim is to increase the number of patients who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research.

The Government’s plan for Growth announced the transformation of incentives for efficiency in initiation and delivery of research, the Department of Health is now seeking to achieve the transparency commitment for this exercise.

The West Hertfordshire Hospitals NHS Trust has been working under one or more NIHR contracts for clinical research and has been submitting information as contractually required on Performance in Initiating and Performance in Delivering Clinical Research. Below is information regarding the 70 day benchmark and recruitment to time and target for commercial contract clinical trials.

Performance in Initiating Clinical Research

For clinical trials with HRA approval where our site was selected in the twelve months prior to end of March 2018.

Trials that were subject to HRA approval - scroll right to view further information in the table
Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial The date the site was invited The date the site was selected The HRA Approval date Date the site was confirmed by the sponsor Date the site was confirmed Date when the site is ready to start Date of the recruitment of first patient Source of the delay The Non-confirmation status Comments
16/WM/0514 213012 The B-ADENOMA Study: Bowel Scope - Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities 21/06/2017 23/06/2017 20/01/2017 28/06/2017 03/07/2017 14/07/2017 21/07/2017 N/A N/A  
17/LO/0334 214459 FLO-ELA: FLuid Optimisation in Emergency LAparotomy. Open, multi-centre, randomised controlled trial of cardiac output -guided haemodynamic therapy compared to usual care in patients undergoing emergency bowel surgery. 05/10/2017 05/10/2017 29/03/2017 26/10/2017 06/11/2017 02/03/2018    Sponsor N/A The sponsor had not provided the required cardiac output monitor device. Green light was therefore not given until 02/03/2018.
16/SS/0137 199347 Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis 2 18/10/2017 24/10/2017 10/01/2017 07/11/2017 15/11/2017      Sponsor N/A The sponsor has not provided the required IMP and therefore the green light has not been given by the sponsor.
16/HRA/5525 210175 A definitive randomised controlled trial investigating two online wellbeing interventions to reduce NHS staff stress 13/02/2018 13/02/2018 23/01/2017 13/02/2018 28/02/2018 05/03/2018 08/03/2018   N/A  
17/EE/0382 220851 Predicting Outcomes For Crohn’s dIsease using a moLecular biomarkEr (PROFILE) trial 02/01/2018 19/02/2018 02/11/2017 22/03/2018 27/03/2018       N/A  

View this data in spreadsheet form

Performance in Delivering Clinical Research

For commercial contract clinical trials hosted by West Hertfordshire Hospitals NHS Trust:

Trial data

Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Target Number Of Patients Agreed? Minimum Number Of Patients Agreed (Enter Same In Both If Only One Number) Maximum Number Of Patients Agreed (Enter Same In Both If Only One Number) Target Date To Recruit Patients Agreed? Date Agreed to recruit target number of patients Total Number Of Patients Recruited At The Agreed Target Date Total Number Of Study Participants Recruited Date That The Trial Closed To Recruitment Reason For Closure Of Trial Comments
16/WA/0110 203204 PIONEER 6: A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes. Number agreed 13 13 Date agreed 31/08/2017   13   13 31/08/2017 Recruitment finished  
14/WS/1146 166537 (Navigate ESUS) Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undete Number agreed 20 20 Date agreed 21/09/2017 31 31 21/09/2017 Recruitment finished  

View this data in spreadsheet form

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