University Hospitals of Leicester NHS Trust Research & Innovation Directorate Performance in Delivering Research 01/04/2015 to 31/03/2016
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1 University Hospitals of Leicester NHS Trust Research & Innovation Directorate Performance in Delivering Research 01/04/2015 to 31/03/2016 REC Date 10/H0808/ EXCEL Clinical Trial 1.0 8th June /03/ Y 12/EM/ EUCLID? Examining use of ticagrelor in PAD patients 30 27/02/ Y 11/SS/ RESPOND CRT 10 14/10/ Y 13/NW/ Global Leaders Study V /11/ N 13/EM/ GadaCAD /03/ Y AMG 145 and Statin Therapy in patients with 12/WM/ Cardiovascular Disease 10 08/05/ Y 13/EM/ VS-6063 Phase II Mesothelioma study 8 30/09/ Y Phase III GA101 or rituximab plus chemo in 1st line 11/NW/ indolent NHL 5 17/01/ Y Tremilimumba in pleural or peritoneal malignant 13/SC/ mesothelioma 2 02/12/ Y 11/LO/ ABSORB II RANDOMIZED CONTROLLED TRIAL 10 04/06/ Y 12/WM/ InovateHF 10 15/12/ Y C25003 Ph3 A+AVD vs ABVD Frontline in Patients with 12/LO/ Hodgkin Lymphoma 8 17/12/ Y COPD Exacerbation Vaccine Study - CCRN /SC/ (COPD) 4 13/11/ Y 09/H0406/ LCZ696 vs enalapril in chronic heart failure 6 11/10/ Y 14/SC/ The CANVAS-R TRIAL - DRN /04/ Y Q4 PID Performance in Delivery University Hospitals of Leicester NHS Trust Page 1 of 6
2 REC Date 14/EE/ OTO-104 in Meniere's Disease 6 17/04/ Y : A Study of Ganetespib in advanced lung 13/LO/ cancer 1 31/10/ Y A Phase 3 Study to Investigate the long term safety 15/NW/ and efficacy of ZS 5 31/10/ Y The Effects of JNJ on Cardiovascular 09/H0402/ Outcomes (CANVAS Study) 0 31/01/ Y 13/SC/ MK /04/ Y 13/LO/ CATCH-AMI 5 08/04/ Y Austri: 6-month Safety and Benefit Study of SERETIDE 12/SC/ in Children 4-11 years 6 06/10/ Y Elagolix in the Treatment of Endometriosis-Associated 13/WA/ Pain (2) 6 13/05/ Y 12/LO/ A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) with Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma 2 28/10/ Y 14/EE/ ASSURE 6 30/11/ N Exenatide Study of Cardiovascular Event Lowering 11/AL/ (EXSCEL) 5 20/02/ Y Ertugliflozin in participants with T2DM & Vascular 14/ES/ disease 5 21/07/ Y 13/EM/ GWP42004 in Type 2 diabetes 6 29/09/ N 14/NW/ Treatment of chronic cough with PA /12/ Y 11/EE/ Efficacy and Safety of Lenalidomide/Dexamethasone +/- Elotuzumab in MM 7 26/09/ N Closed to, Follow Complete Q4 PID Performance in Delivery University Hospitals of Leicester NHS Trust Page 2 of 6
3 REC Date 12/EM/ A longterm Safety study for asthmatic subjects 5 28/03/ N 11/EE/ MO /03/ N 10/MREC00/61 An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety 3 27/11/ Y CBAF312A2304 siponimod in secondary progressive 13/SC/ multiple sclerosis v1 6 31/12/ N 14/EM/ An Extension Study to MEA in Severe Asthma 6 31/03/ N CheckMate 238: CHECKpoint pathway and nivolumab 15/SC/ clinical Trial Evaluation /09/ N Study to evaluate safety & efficacy of Blisibimod in IgA 14/EM/ Nephropathy 4 28/01/ Y GO29294 Anti-PDL1 Bladder Cancer Phase III Version 14/LO/ /01/ Y Neratinib after Trastuzumab in early stage breast 09/H0405/ cancer /10/ N 12/WS/ The NEFIGAN Trial 4 28/11/ N 09/H0706/ Aliskiren vs enalapril in chronic heart failure 4 27/12/ N Study of Eosinophilic Granulomatosis with Polyangiitis 13/EM/ and Mepolizumab 3 22/05/ Y AUY922 in NSCLC patients with EGFR mutations after 12/EM/ TKI treatment 3 05/06/ Y GO28509 PEGGY - Phase 2 study of GDC-0941 in 13/LO/ metastatic breast cancer 2 01/07/ Y 14/LO/ Bosutinib vs Imatinib in Newly Diagnosed CML 3 20/08/ Y 10/H0406/ ABSORB Extend 15 28/11/ N 11/EM/ WA25204RA with CV Outcomes (Entracte Study) 6 30/06/ N Closed to, Follow Complete Q4 PID Performance in Delivery University Hospitals of Leicester NHS Trust Page 3 of 6
4 REC Date 12/WM/ INCB The RELIEF study 5 22/11/ N 13/EM/ Oral Semaglutide Dose Range in Type 2 (SNAC) 8 21/04/ N MK-3475 versus SOC in 1L Subjects with PD-L1 Strong 14/LO/ Metastatic NSCLC 3 02/11/ N 11/AL/ B Phase 2 Study in Polycystic Kidney Disease 5 25/05/ N 12/EM/ SCULPTURE Extension Study 2 28/03/ N Comparison of Lantus, Lixisenatide and Lixilan in Type 13/LO/ diabetes 3 30/10/ N Elagolix in the treatment of menstrual bleeding with 13/EE/ Uterine Fibriods 3 31/12/ N 13/EE/ SIGNATURE Study CAIN457AGB /02/ N 14/SC/ AWARD-9 (GBDI Study) 5 27/02/ N 12/SC/ DPMCF204 mannitol in CF aged 6-17 years 4 25/04/ N A monotherapy study of ertugliflozin in participants 13/NE/ with T2DM 7 07/07/ N LDK378 vs Chemo in ALK+ NSCLC in patients who 13/EM/ failed crizotinib 1 13/10/ Y 047 FIT (Fostamatinib for Immune Thrombocytopenia) 14/EM/ Study 2 25/01/ N A Phase 3 Study of Pacritinib in Patients with 14/EM/ Myelofibrosis 2 31/01/ N Open-label study of GDC-0199 in follicular lymphoma 14/LO/ patients 2 29/02/ N NN , NNC in paediatric, 12/NE/ previously treated subjects 1 28/02/ N Ibrutinib in Chronic Lymphocytic Leukaemia/Small 13/YH/ Lymphocytic Lymphoma 1 19/06/ N Q4 PID Performance in Delivery University Hospitals of Leicester NHS Trust Page 4 of 6
5 REC Date 13/EM/0084 Baxter :PEGylated Recombinant Factor VIII in Severe Hemophilia A 1 28/11/ N 13/NE/ NN Paediatric PTP Study in Haemophilia A 1 07/02/ N 12/EM/0018 CANTOS- CACZ885M2301 Canakinumab in postmi patients with raised hscrp 10 25/02/ N 13/WM/ SHINE MCL /12/ N 14/EM/1068 Open label, phase 3 trial comparing Mylans Glargine with Lantus 5 24/03/ N 13/EM/0340 ABT-199 Monotherapy in Relapsed/Refractory CLL With the 17p Deletion 1 12/05/ N 13/EM/0460 Study of Adjuvant Kadcyla vs Herceptin, HER2+ve Primary Breast Cancer 6 22/05/ N 14/EE/ ENSURE in AF (atrial fibrillation) study 5 28/10/ N 14/SC/0181 Elagolix in Endometriosis Associated Pain Extension Study 6 15/12/ N 14/WM/0170 Phase III study of Momelotinib in Patients with Myelofibrosis 2 12/01/ N A UK Phase IIIB expanded access study of INC424 in 11/SC/ myelofibrosis 3 30/11/ N 12/LO/ Aflibercept SQoP (AFLIBC06097) 5 30/04/ N 12/LO/ MASERATI 100 Permacol Collagen Paste Study 10 28/02/ N Closed 12/NE/0009 Study of GDC-0941 for the treatment of non-small cell lung cancer (FIGARO) 9 01/09/ N Closed 12/NW/0242 Clinical trial of an investigational medicinal product (CTIMP) 15 01/03/ N Closed 12/SC/0139 SafeHer: Safety study with subcutaneous Trastuzumab in breast cancer 10 30/11/ N 13/LO/1766 EMR : Phase I study of MSB C in solid tumors 3 11/01/ N Suspended 14/EM/ Tiotropium + Olodaterol (PHYSACTO[TM]) in COPD 3 20/10/ N Q4 PID Performance in Delivery University Hospitals of Leicester NHS Trust Page 5 of 6
6 REC Date 12/LO/1313 ROX CONTROL HTN STUDY: Protocol RH-02 Version , June 20, /05/ N 12/LO/0491 Surgical Replacement & Transcatheter Aortic Valve Implantation SURTAVI 5 29/02/ N 12/LO/1825 Rilotumumab (AMG 102) with ECX in advanced gastric cancer 3 30/11/ N 12/NE/0333 Tasquinimod in patients with advanced/ metastatic HCC,GC,OAC and RCC 10 25/07/ N 12/SC/0173 Saxagliptin with metformin in paediatric type diabetes patients 2 02/07/ N 13/EE/ Revacept/CS/ /06/ N Closed 13/LO/0219 GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) 2 31/07/ N Closed 13/YH/0140 EDIFY: Ivabradine in heart failure with preserved ejection fraction 4 31/07/ N 14/EM/0209 Colourstart? Test 73 mcg Cutaneous Patch. TDL-CS Version /09/ N 14/NW/ TERI-PRO 7 07/11/ N 08/H0502/ BH Mircera? vs. reference ESAs in CKD patients 20 14/10/ N Abandoned Q4 PID Performance in Delivery University Hospitals of Leicester NHS Trust Page 6 of 6
Recruitment Target 14/EM/1003. GO PH III, OPEN-LABEL, IN RELAPSED/REFRACTORY PATIENTS WITH CLL 3 15/05/2019 Open N/A 14/EM/0034
20080763 Panitumumab vs Cetuximab in 09/H0402/92 Colorectal Cancer 10 05/01/2015 Closed - Follow Up Complete Y 09-WSE04-55 BO21004 - RO5072759 Safety and Efficacy Chemo Combo in untreated CLL 5 01/04/2022
Panitumumab vs Cetuximab in Colorectal Cancer 10 05/01/2015 Closed - Follow Up Complete Y 09/H0402/92
University Hospitals of Leicester NHS Trust Research & Innovation Directorate Performance in Delivering Research 1st January 2015 to 31st December 2015 closed Trial Status met? S38093 in addition to Donepezil
Min number of patients agreed to be recruited. Max number of patients agreed to be recruited
be 12/SC/0139 98125 A PHASE III PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI- CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS
University Hospitals of Leicester NHS Trust Research & Development Directorate Performance in Delivering Research
University Hospitals of Leicester NHS Trust Research & Development Directorate Performance in Delivering Research 1st April 2014 to 31st March 2015 Performance in Initiating and Delivering Clinical Research
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
University Hospitals of Leicester NHS Trust Research & Development Directorate Performance in Delivering Research
University Hospitals of Leicester NHS Trust Research & Development Directorate Performance in Delivering Research 1st July 2013 to 30th June 2014 met? 13/WA/0084 14/EM/0101 14/SC/0185 11/AL/0327 11/YH/0121
University Hospitals of Leicester NHS Trust Research & Development Directorate Performance in Initiating Research
University Hospitals of Leicester NHS Trust & Development Directorate Performance in Initiating 1st January 2013 to 31st December 2013 12/LO/1697 BEL114674: A 2 year study of efficacy and safety of intravenous
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University Hospitals of Leicester NHS Trust Research & Development Directorate Performance in Initiating Research
Performance in Initiating and Delivering Clinical University Hospitals of Leicester NHS Trust & Development Directorate Performance in Initiating 1st April 2013 to 31st March 2014 12/LO/1313 07/Q1604/33
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
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Target date to recruit patients agreed? Target range minimum. Target range maximum
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 Total no of patients recruited
Perfomance in Delivering (Commercial Trials)
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Performance Against Dirst Patient Visit Benchmark
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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?
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
The Pennine Acute Hospitals NHS Trust Performance in delivering clinical research Reporting period 1 October 2017 to 30 September 2018
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A - Nonconfirmation Suspended by Sponsor B - D - Date site. C - Closed ready to start. Permissions. Sponsor delays ied. delayed/den.
No REC Reference Number IRAS No Title Submission Type Valid Research Application Date of First Patient Recruitment Benchmark Met invited selected Approval date confirmed by sponsor confirmed A - Nonconfirmation
Performance in Delivering Q4. Target number of patients
Performance in Delivering Q4 Research Ethics Committee Reference Number Name of Trial Target number of patients Date Agreed to recruit target number of patients Trial Status Target met within the agreed
Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January December 2014
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