The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018
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1 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? Date of first patient recruited invited selected HRA Approval date confirmed by sponsor confirmed ready to start Reasons for delay correspond to: 16/EE/ MesoTRAP: A pilot clinical trial and feasibility study comparing videoassisted thoracoscopic partial pleurectomy/decortica tion with indwelling pleural catheter in patients with trapped lung due to malignant pleural mesothelioma designed to address recruitment and randomisation uncertainties and sample size requirements for a phase III trial 17/EE/ A phase 2B, randomized, doubleblind, activecomparator-controlled, dose- ranging clinical trial to evaluate the No 14/08/ /10/ /02/ /10/ /11/ /12/2017 Neither Yes 12/03/ /10/ /12/ /12/ /12/ /12/ /12/2017 Neither
2 safety, tolerability, antiretroviral activity, and pharmacokinetics of MK-8591 given in combination with Doravirine (DOR) and Lamivudine (3TC) in HIV-1-infected treatment-naive adults 17/EM/ RCT and meta-analysis testing effectiveness and cost-effectiveness of a tailored text message programme (MiQuit) for smoking cessation in pregnancy 16/NW/ A window of opportunity study to assess the biological effects of enobosarm in oestrogen receptor positive, androgen receptor positive early breast cancer 16/NE/ The British Heart Foundation older patients with non-st segment elevation myocacdial infarction randomized interventional treatment trial 17/LO/ Helping pregnant smokers to quit: A multi-centre RCT of electronic cigarettes vs Yes 20/12/ /11/ /11/ /11/ /11/ /12/ /12/2017 No 07/07/ /01/ /03/ /02/ /02/ /03/2018 Sponsor No 31/10/ /01/ /08/ /01/ /02/ /03/2018 Neither Yes 23/01/ /11/ /12/ /07/ /01/ /01/ /02/2018
3 nicotine patches (usual care) 17/WM/ Refining and testing the diagnostic accuracy of an assessment tool (PAT-POPS) to predict admission and discharge of children and young people who attend an emergency department 17/YH/ Paediatric use of the Abbott sensor based glucose monitoring system for 21 days - an accuracy evaluation 18/NW/ A phase 2a, randomised, partiallyblind, placebocontrolled study to assess the efficacy, safety, and pharmacokinetics of 24 weeks of treatment with multiple doses of JNJ as aonotherapy and in combination with a nucleos(t)ide analogue in subjects with chronic hepatitis B virus Infection 18/NW/ Better maternity care pathways in pregnancies after stillbirth or neonatal Yes 21/02/ /11/ /12/ /12/ /05/ /01/ /01/2018 Yes 15/03/ /12/ /02/ /02/ /02/ /02/ /02/2018 Yes 23/05/ /12/ /03/ /03/ /03/ /03/ /04/2018 Sponsor Yes 11/06/ /12/ /03/ /03/ /03/ /03/ /02/2018 Neither
4 death: A feasibility study 17/EE/ A double-blind, placebo-controlled, randomized trial to determine the safety and efficacy of EMA mg b.i.d. in reducing 24-hour average pain intensity score in patients with painful diabetic neuropathy (EMPADINE) 17/WA/ A randomised, doubleblind, placebocontrolled phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson s disease dyskinesia 17/YH/ Multiple interventions of diabetic foot ulcer treatment trial (MIDFUT) 17/EM/ A phase III, randomized, multicenter, parallelgroup, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1- Yes 26/03/ /12/ /02/ /01/ /02/ /03/ /03/2018 Yes 10/05/ /01/ /03/ /01/ /03/ /03/ /04/2018 No 18/10/ /02/ /05/ /02/ /03/ /04/2018 Neither Yes 26/04/ /08/ /02/ /02/ /04/ /04/ /04/2018
5 infected adults who are virologically suppressed 16/LO/ SMILE: Strategy for maintenance of HIV suppression with elvitegravir+darunavir/ ritonavir in children (PENTA 17). A twoarm, Phase 2/3 multicentre, openlabel, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to elvitegravir (EVG) administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants 17/WS/ NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease (Pontiac II); a prospective randomized trial No 09/11/ /12/ /07/ /03/ /04/ /05/2018 Sponsor Yes 22/06/ /01/ /04/ /04/ /05/ /05/ /06/2018
6 17/SC/ A phase 3 randomized, double-blind, placebocontrolled, parallelgroup efficacy and safety study of SHP647 as induction therapy in subjects with moderate to severe ulcerative colitis (FIGARO UC 301) 17/LO/ A randomized, doubleblind, placebocontrolled study to assess the effects of bempedoic acid (ETC- 1002) on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease who are statin intolerant 18/SW/ Induction of labour for predicted macrosomia - the 'Big Baby Trial' 17/SC/ A phase 3 randomized, double-blind, placebo controlled, parallel group efficacy and safety study of SHP647 as maintenance therapy in subjects with moderate to severe ulcerative colitis (FIGARO UC 303) Yes 02/08/ /01/ /05/ /03/ /05/ /05/ /07/2018 Neither No 28/03/ /05/ /06/ /06/ /06/ /06/2018 Neither Yes 18/07/ /05/ /05/ /03/ /06/ /07/ /07/2018 Sponsor No 08/01/ /05/ /03/ /05/ /05/2018 Sponsor
7 17/SC/ A phase 3 long-term safety extension study of SHP647 in subjects with moderate to severe ulcerative colitis (AIDA) 17/SC/ A phase II study of atezolizumab with rituximab, gemcitabine and oxaliplatin in patients with relapsed or refractory diffuse large b-cell lymphoma who are not candidates for highdose therapy 16/EE/ Post-operative avoidance of radiotherapy: biomarker selection of women categorised to be in a very low risk group by IHC4+C 17/NW/ A randomized, doubleblind, placebocontrolled, parallelgroup, multi-center study to assess the efficacy, safety and tolerability, and pharmacokinetics of INS1007 administered once daily for 24 weeks in subjects with noncystic fibrosis bronchiectasis - the No 08/01/ /05/ /03/ /05/ /05/2018 Sponsor No 12/02/ /06/ /01/ /05/ /07/ /07/2018 Neither No 16/03/ /05/ /11/ /07/ /07/2018 Sponsor No 20/12/ /07/ /07/ /07/ /08/2018
8 Willow Study.
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
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
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
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 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April March 2014
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April 2013-31 March 2014 Research Ethics Committee Name of Trial reference number 1 08/H0906/140
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
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
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
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
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)
15/NW/0004 162679 Studies proceeding under pre HRA-roval system (NHS Permission) A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST- LINE METASTATIC COLORECTAL
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
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
The Nottingham eprints service makes this work by researchers of the University of Nottingham available open access under the following conditions.
Naughton, Felix and Foster, Katharine and Emery, Jo and Cooper, Sue and Sutton, Stephen and Leonardi- Bee, Jo and Jones, Matthew and Ussher, Michael and Whitemore, Rachel and Leighton, Matthew and Montgomery,
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
Integrated Research Application System Number. Total Number Of Study Participants Recruited. Research Ethics Committee Reference Number
Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Minimum Number Of Patients Agreed Maximum Number Of Patients Agreed Date That The Trial Closed To
Performance in Initiating and Delivering Clinical Research
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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
Inflammatory bowel disease (IBD) Overview of the Paediatric investigation plans. Presented by: Richard Veselý. An agency of the European Union
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A - Permissions delayed/den ied. Date site ready to start. B - Suspended by Sponsor. C - Closed D - Sponsor
No REC Reference IRAS No Number Title Date of First Patient Recruitment Benchmark Met invited selected HRA Approval date confirmed by sponsor confirmed ready to start A - Permissions delayed/den ied B
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?
Description of Commitment
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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
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
Performance in Initiating and Delivering Clinical Research
Performance in Initiating and Delivering Clinical Research As a global leading centre for research in Eyes and Vision, it is a key priority to offer as many patients as possible the opportunity to get
First Patient Recruited? 17/07/2015 Yes 07/09/2015 Yes. 17/07/2015 Yes 11/09/2015 Yes. 31/07/2015 Yes 06/08/2015 Yes
Research Ethics Committee Reference Number Name of Trial Date of Receipt of Valid Research Application First Patient Recruited? Date of First Patient Recruited Benchmark Met Reasons for delay correspond
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