Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April March 2014
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1 Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April March 2014 Research Ethics Committee Name of Trial reference number 1 08/H0906/140 A randomised, double-blind, parallel-group, placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke. Study 12649A DIAS-4 26 Aug /LO/0105 Open label,single arm,phase IV, multi centre trial to explore the immunogenicity of the liquid formulation of Saizen in subjects with growth hormone deficiency (GHD) of adult onset 3 12/EE/0533 A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin 4 11/NW/0548 Phase III RIALTO: A Randomised Investigation of Alternative Ofatumumab containing regimens in less fit patients with CLL 5 12/EE/0492 A Multicenter, Randomized, Placebo- Controlled Study of SBC-102 in Patients with Lysosomal Acid Lipase Deficiency Date of receipt of valid research application Date of first patient first visit Reason for not achieving benchmark 21/03/2013 No patients 27/03/ /07/2013 Staff availability issues 31/01/ /06/2013 Sponsor delays 20/06/2012 Permissions 01/03/2013 Permissions /contracting delays 6 13/LO/0157 Study MAG104615, A Proof of Concept Study for GSK versus placebo in Stroke Patients 15/05/2013 No patients 7 13/NW/0362 Effect of Lateral WEDGE insoles on Osteoarthritis knee pain and joint loading. The WEDGE study 02/05/ /09/2013 Staff availability issues 8 13/SC/0092 A Multi Center, Randomized, Double Blind, Parallel Group, Placebo Controlled Variable Treatment Duration Study evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients with Secondary Progressive 15/05/2013 Sponsor delays
2 Multiple Sclerosis 9 13/LO/0383 A Randomized, Double Blind, Double Dummy, ActiveControlled Study to Evaluate the Efficacy and Safety of REGN727/SAR in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins 10 12/SS/0059 A Randomised Controlled Clinical Trial of Adjunctive Mechanical Thrombectomy Compared with Intravenous Thrombolysis in Patients with Acute Ischaemic Stroke due to an Occluded Major Intracranial Vessel 11 13/EM/0052 SPIRiT Serum Phosphate Intervention in Renal Replacement Therapy 31/05/2013 No patients 24/05/2013 Sponsor delays 03/07/2013 Sponsor delays 12 12/EE/0532 A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus 31/05/2013 Permissions /contracting delays 13 13/NW/0130 Delivering a Mouth Hygiene Complex Intervention for Stroke Unit Care: A Pilot Study 13/03/ /06/2013 Permissions 14 13/EM/0095 A Phase III Randomised, Multicentre Study of Subcutaneous Secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks & to assess the long term efficacy up to 5 years in patients with Active Psoriatic Arthritis /H1011/47 Is systemic or tissue coagulation a prognostic indicator in Cancer 14/05/ /06/2013 N/A 14/06/2013 Sponsor delays 16 12/NW/0090 Feasibility trial of a respiratory symptom intervention 03/05/ /09/2013 Permissions /no patients 17 12/NW/0387 Right Ventricular Pacing And Ventricular Dysfunction(RVPAVD Study): Pathophysiological Mechanisms and Predictors of Progression To Biventricular Dysfunction Following Right Ventricular Pacing 15/08/2013 No patients
3 18 13/LO/0736 GP15302: Randomised Study To Compare GP2015 and Enbrel in Psoriasis 10/06/ /11/2013 Sponsor delays 19 13/EE/0038 Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double blind placebo controlled trial 20 12/NW/0790 The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multicentre randomised controlled trial 21 13/LO/0072 A Randomized, Double blind, Placebo controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis 22 12/NW/0361 A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: (SANADII) 23 12/NW/0814 Efficacy & Safety/Tolerability of Subcutaneous SCH900222/MK /06/ /09/2013 N/A 03/07/ /10/2013 No patients 06/08/ /09/2013 N/A 03/08/ /09/2013 N/A 13/02/ /11/2013 Sponsor delays 24 13/LO/0195 Momentum study extension - MT-1303-E05 06/08/2013 Permissions 25 11/WA/0053 Leukaemia Lymphoma Research and NCRI Working Group Pick a Winner Programme (LI1) Trial 11/10/ /12/2013 No patients 26 12/SS/0211 Efficacy and safety of MRI-based thrombolysis in wake up stroke: a randomised, doubleblind, placebocontrolled trial 18/03/2013 Permissions /sponsor delay 27 12/WA/0308 A Study of Ixekizumab in Patients with Psoriatic Arthritis 28/11/2013 Sponsor delays
4 28 13/NW/0560 Effect of Passive Immunization on the Progression of Mild Alzheimers Disease: Solanezumab (LY ) Versus Placebo 18/09/2013 Sponsor delays 29 13/NW/0496 Pregabalin in subjects with Primary Generalised Tonic-Clonic seizures 22/10/2013 Sponsor delays 30 12/NW/0802 Study of Oral Laquinimod in Subjects with Multiple Sclerosis 09/07/2013 Sponsor delays 31 13/EE/0241 Novartis CAIN457AGBOI 18/09/ /10/2013 N/A 32 12/EE/0171 BEL A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy 03/01/ /02/2014 N/A 33 13/EM/0154 A multicentre randomised controlled trial evaluating cast treatment versus surgical fixation on wrist function for fractures of the scaphoid waist in adults (SWIFFT) 34 11/H1307/6 SWITCH: Randomised controlled trial of switching to alternative tumournecrosis factor (TNF)blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNFblocking drug /LO/1115 UK Multicentre Openlabel Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients 13/12/2013 No patients 05/12/ /03/2014 Permissions 03/01/ /03/2014 Sponsor delays 36 13/SC/0558 CAIN457A3301 Secukinumab in treatment of chronic palmoplantar pustular psoriasis 05/12/ /03/2014 Permissions / 37 12/NW/0386 A two-part, phase 1 single-dose study to assess doses of IL-31 mab 01/10/2013 Sponsor delays
5 38 12/NE/0410 MK /02/2014 N/A 39 13/NS/2002 Therapeutic Interventions for Stones of the Ureter (TISU): a multicentre randomised controlled trial of extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones /NW/0012 Viscoseal PostArthroscopic Release of Adhesive Capsulitis of the Shoulder: a randomised, controlled proofofprinciple study in adults (version 1). 07/02/2014 N/A 13/01/2014 Sponsor delays 41 13/NW/0460 Does subcutaneous interleukin1 receptor antagonist reduce inflammation following ischaemic stroke compared to placebo? 13/02/ /03/2014 N/A 42 13/NW/0081 Reducing unnecessary admissions for chest pain with the Manchester Acute Coronary Syndromes (MACS) decision rule: feasibility study 07/02/2014 N/A 43 14/YH/0005 IMPERIUM (IOQL) 11/02/2014 N/A 44 14/NW/005 A randomised, doubleblind,placebocontrolled proofofconcept study of the efficacy of gevokizumab 60 mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease 45 13/NW/0773 A randomised controlled trial to assess the efficacy of daily wax bath treatment in patients with scleroderma. 21/02/2014 N/A 11/03/ /03/2014 N/A 46 13/SS/0224 A Multicenter, DoubleBlind,Randomized, PlaceboControlled,DoseResponse Trial of YKP3089 as Adjunctive Therapy in Subjects with Partial Onset Seizures, with Optional OpenLabel Extension 47 12/SS/0138 REstart or STop Antithrombotics Randomised Trial (RESTART) 19/02/2014 N/A 18/02/2014 N/A
6 48 13/WA/0084 A Randomised, Double Blind, Placebo Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK3102 in Subjects with Type 2 Diabetes Mellitus 49 13/LO/0651 VAP-Rapid-2 Biomarkerbased exclusion of VAP for improved antibiotic stewardship 20/12/2013 Sponsor delays 09/09/ /01/2014 Contracting delays
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October September 2013
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October 2012-30 September 2013 Research Ethics Committee reference number Name of Trial 1 12/NW/0321
Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January December 2014
Table 2: Salford Royal HS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January 2014 1 December 2014 Research Ethics Committee reference number 1 12/W/0321 2 11/LO/1986
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July June 2013
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July 2012-30 June 2013 Name of trial Note, some study titles are shortened 1 Long-Term Study
Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January 31 December 2015
Research Ethics Committee reference number Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January 31 December 2015 Name of trial 1 11/LO/1823
Table 1 Salford Royal NHS Foundation Trust: Performance in initiating clinical research (HRA Approval) Reporting period 1 April March 2017
Table 1 Salford Royal NHS Foundation Trust: Performance in initiating clinical research (HRA Approval) Reporting period 1 April 2016 31 March 2017 REC reference IRAS number Study title 16/NW/0428 207062
The Pennine Acute Hospitals NHS Trust Performance in delivering clinical research Reporting period 1 October 2017 to 30 September 2018
The Pennine Acute Hospitals NHS Trust Performance in delivering clinical research Reporting period 1 October 2017 to 30 September 2018 REC reference IRAS reference Name of trial Target number of? Minimum
The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018
The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018 REC reference IRAS reference Name of trial First patient recruited?
Performance in Initiating Clinical Research
Performance in Initiating Clinical Research January 2016 December 2016 NHS Permissions Site approval Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial
Performance in Initiating and Delivering Clinical Research Why are we doing this?
Performance in Initiating and Delivering Clinical Research Why are we doing this? Through the NIHR (National Institute for Health Research) the Government wishes to see a dramatic and sustained improvement
Perfomance in Delivering (Commercial Trials)
Perfomance in Delivering (Commercial Trials) REC Ref IRAS ID Name of Trial Target Of? Minimum Of Maximum Of Target Date To Recruit? Total Date Of to recruit target number Recruited At of patients The Target
Performance in delivering Clinical Research at PHT Q3 14/15 study met the 70 day target study within 70 day target study not met 70 day target
Performance in delivering Clinical Research at PHT Q3 14/15 study met the 70 day target study within 70 day target study not met 70 day target Research Ethics Committee 14/ES/0004 ALA-BCC-CT008 - A randomized,
Target date to recruit patients agreed? Target range minimum. Target range maximum. Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date No of patients recruited
Performance of Initiating Q South London and Maudsley NHS Foundation Trust:
Research Ethics Committee Reference Number Integrated Research Application System Number Submission Type Name of Trial Date of Receipt of Valid Research Application Date of NHS First Patient Recruited?
South London and Maudsley NHS Foundation Trust: FY1819 Q2 Performance in Initiating
of First 17/YH/0195 228739 17/YH/0196 228435 17/LO/0987 215947 17/LO/1314 224111 17/WM/0441 224759 17/LO/1867 229005 A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity
Performance in Initiating Clinical Research Q2 2016/17
Performance in Initiating Clinical Research Q2 2016/17 Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Date of Receipt of Valid Research Application
University Hospitals of Leicester NHS Trust Research & Development Directorate Performance in Initiating Research
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Date of NHS Permission. Date of First Patient Recruited. Date Site Invited
Reference of Receipt of of NHS of First 14/WA/1075 150715 NHS HeadPoST Version 2.1 23/11/2015 05/01/2016 11/01/2016 N/A 12/YH/0452 106985 NHS INCA 10/12/2015 15/01/2016 17/03/2016 N/A Excess Treatment
Studies proceeding under pre HRA-Approval system (NHS Permission)
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Performance in Initiating Clinical Research Q4 2015/16
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Min number of patients agreed to be recruited. Max number of patients agreed to be recruited
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Target date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished.
No REC Reference IRAS No Title Target number of agreed? Target range minimum Target range maximum Target date to recruit agreed? Planned Recruitment end date Total no of recruited at the agreed target
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