Performance in Initiating Clinical Research Q2 2016/17
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1 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 Date of First Patient Recruited Comments Reasons for delay correspond to: 14/SC/ /LO/ /SW/ /WA/ /LO/ A pragmatic multi-centre, blinded, randomised placebocontrolled trial comparing Platelet Rich Plasma injection (PRP) to placebo (imitation) injection in adults with Achilles tendon rupture. Two sub-studies are embedded with main study to contribute to the understanding of the PRP mechanism in tendon healing (PATH2) A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with ER+ primary breast cancer (PALLET) PREMISE: A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated with Enzalutamide Treatment in patients with metastatic Castration Resistant ProState CancEr (mcrpc) Palliative radiotherapy in addition to self-expanding metal stent for improving outcomes of dysphagia and survival in advanced oesophageal cancer (ROCS) Planning treatment for oesophago-gastric cancer: A randomised maintenance therapy trial (PLATFORM Trial) 28/09/ /01/2016 No 30/09/ /05/2016 No 01/10/ /10/2015 Yes 24/09/ /01/2016 No 09/10/ /03/2016 No target of 2. Site target of 6 70
2 14/WS/ /WA/ /YH/ /SW/ /EE/ /WM/ /SC/ /ES/ Multicentre, randomised, double-blind, double-dummy, active-comparator, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undermined Source (ESUS), comparing rivaroxaban 15mg once daily with aspirin 100mg (NAVIGATE ESUS) Prevalence of Lower Urinary tract Symptoms in Hip and Knee Replacement Study (PLUS Study) A phase II randomised, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases treated with hormonal treatment background therapy (BAYER 16298) A phase II randomised, double-blind, placebo-controlled trial of radium-223 dichloride in combination with exemestane and everolimus versus placebo in combination with exemestane and everolimus when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases (BAYER 17096) A Phase III Randomised Trial of MK (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or astatic Head and Neck Cancer De-ESCALaTE HPV: Determination of Epidermal growth factor receptor-inhibitor (cetuximab) versus Standard Chemotherapy (cisplatin) early And Late Toxicity Events in Human Papillomavirus-positive oropharyngeal squamous cell carcinoma A phase III double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumours (ADD-ASPIRIN) A randomised phase II/III study to assess the efficacy of trametinib (GSK ) in patients with recurrent or progressive low-grade serous ovarian cancer or peritoneal cancer (LOGS) 23/10/ /01/2016 No 22/10/ /11/2015 Yes 13/11/ /03/2016 No 13/11/ /03/2016 No 20/11/ /12/2015 Yes 18/11/ /12/2015 Yes 25/11/ /02/2016 No 02/12/ /03/2016 No Site target of 6 target of 5 target of 5
3 15/YH/ /SS/ /WA/ /EE/ /LO/ /WM/ /EM/ /NW/ A 21-week, open-label, randomised, controlled, parallelgroup, multi-centre study evaluating the efficacy and safety of HOE901-U300 administered according to a devicesupported treat-to-target regimen routine titration in T2DM patients (AUTOMATIX) Randomised, double-blind, multicentre, phase III trial evaluating the safety and benefit of adding Everolimus to adjuvant hormone therapy in women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving at least 1 year of adjuvant hormone therapy (UNIRAD) Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome (AML19) A phase 2 randomised, double-blind, placebo-controlled, trial of MHAA4549A, a monoclonal antibody, in combination with Oseltamivir versus Oseltamivir for treatment of severe Influenza A infection (INFLUENZA-A) A Randomised phase II trial of Adaptive Image guided standard or Dose Escalated tumour boost Radiotherapy in the treatment of transitional cell carcinoma of the bladder (RAIDER) Multi-centre, randomised, controlled trial to compare the clinical and cost-effectiveness of a 'vein bypass first' with a 'best endovascular first' revascularisation strategy for severe limb ischaemia due to infra-popliteal arterial disease: Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-2) A phase III randomised, open-label, multi-centre, global study of MEDI4736 in combination with Tremelimumab versus standard of care treatment of first-line recurrent or metastatic squamous cell head and neck cancer patients (KESTREL) Response to Optimal Selection of neo-adjuvant Chemotherapy in Operable breast cancer: A randomised phase III, stratified biomarker trial of neo-adjuvant 5- Fluorouracil, Epirubicin and Cyclophosphamide vs Docetaxel and Cyclophosphamide chemotherapy (ROSCO) 11/12/ /02/2016 Yes 11/01/ /06/2016 No 12/01/ /02/2016 Yes 15/01/2016 No 01/02/ /02/2016 Yes 15/02/2016 No 09/02/ /04/2016 Yes 22/02/ /03/2016 Yes target of 8 Site target of 2 target of 2 within 70 date target of 5.
4 14/NW/ The Bedside Evaluation of Sensitive Troponin (BEST) study 02/03/ /03/2016 Yes 15/LO/ /WA/ /YH/ /NE/ /EM/ /NW/ /NW/ : Efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes mellitus. A 78-week, randomised, double-blind, double-dummy, activecontrolled, parallel-group, multi-centre, multi-national, fourarmed trial (PIONEER 3) A randomised, double-blind, placebo controlled, phase II study of fulvestrant with or without the addition of vandetanib as treatment for patients with metastatic breast cancer resistant to aromatase inhibitor therapy (FURVA) GALACTIC: GA-101 (obinutuzumab) monoclonal Antibody as Consolidation Therapy in CLL UK FROST (United Kingdom Frozen Shoulder Trial: Multicentre, randomised controlled trial with economic evaluation and nested qualitative study comparing early structured physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a frozen shoulder (Adhesive Capsulitis) A randomised, double-blind, placebo-controlled study of the safety and efficacy of Amatuximab in combination with Pemetrexed and Cisplatin in subjects with unresectable malignant pleural Mesothelioma (MORAb ) A twenty-six week, randomised, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of Toujeo? compared to standard of care insulin for initiating basal insulin in insulin na?ve patients with uncontrolled type 2 diabetes mellitus, with 6- month extension (REACH) A twenty-six week, randomised, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transitition to Toujeo? compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with 6-month extension (REGAIN) 15/03/ /03/2016 Yes 18/03/ /04/2016 Yes 31/03/ /09/2016 No 14/04/ /04/2016 Yes 18/04/ /08/2016 No 29/03/ /06/2016 No 29/03/ /06/2016 No total target of 6 target of 4 total Site not given green light by Sponsor until 02/06/2016. drug supplies took 2 weeks to arrive on site following green light. Site not given green light by Sponsor until 02/06/2016. drug supplies took 2 weeks
5 14/LO/ /WM/ /LO/ /LO/ Improving radical treatment through MRI evaluation of pelvic sigmoid cancers (the IMPRESS trial) Supporting adults with Type 1 Diabetes to undertake exercise; Developing and piloting an education programme for exercise in Type 1 Diabetes (EXTOD Education) OCTOPUS: Ovarian Cancer Trials of Weekly Paclitaxel - Umbrella Study. A randomised, phase II Umbrella trial of weekly Paclitaxel +/- novel agents in platinum-resistant ovarian cancer TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer 16/05/2016 No 05/05/ /06/2016 Yes 16/06/2016 No 16/06/2016 No 14/SW/ Long Term investigative Follow-up in TrialNet (LIFT TN16) 30/06/2016 No 15/NS/ /SC/ /LO/ Hartmann's type procedure versus intersphincteric APE in patients undergoing resection of rectal cancer in whom restoration of gastrointestinal continuity is not appropriate: a multi centre, prospective observational study (the HiP study) An open label, single arm, multicentre study to assess the clinical effectiveness and safety of Lynparza (Olaparib) capsules maintenance monotherapy in platinum sensitive relapsed somatic or germline BRCA Mutated Ovarian Cancer patients Prevention of Respiratory Insufficiency after Surgical Management (PRISM) Trial: A pragmatic randomised controlled trial of continuous positive airway pressure (CPAP) to prevent respiratory complications and improve survival following major abdominal surgery 14/06/2016 No 16/06/2016 No 27/06/ /08/2016 Yes to arrive on site following green light. target of 5. met target of 3. patient randomised target of 1. target of 4. target of 2.
6 Research Ethics Committee Reference Number Integrated Research Application System Number 16/LO/ /EM/ Name of Trial External pilot study to inform the design and conduct of the Fluids in Shock (FiSh) Trial A phase III, double-blind, randomised placebocontrolled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-gene trial First Patient Recruited? Date of First Patient Recruited Invited Selected HRA Approval Date Confirmed By Sponsor Confirmed Ready To Start No No 28/04/ /06/ /06/ /06/ /08/ /08/2016 No No 09/09/ /10/ /06/ /08/ /08/ /09/2016 Comments Delayed while larger referral site opened Contracting delay
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 Clinical Research Q4 2015/16
Performance in Initiating Clinical Research Q4 2015/16 Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Date of Receipt of Valid Research Application
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
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
OPEN TRIALS Accruals counted until 30-April Current Accrual
Disease group Breast OPEN TRIALS Trial Title Accrual Target IBCSG 48-14 POSITIVE IBCSG 50-14 OLYMPIA IBCSG 52-15 PALLAS SAKK 21/12 A study evaluating the pregnancy outcomes and safety of interrupting endocrine
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
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
Date of HRA. Date Site Invited. Date Site Selected. Approval. Recruited. Date
14/LO/0259 134883 RE-AKT: A randomised Phase II study of enzalutamide (MDV3100) in combination with AZD5363 in s with Metastatic Castration - Resistant Prostate Cancer Yes 08/01/2018 01/07/2016 01/07/2017
HRA Approval Date Site Date Site Sponsor. Non- Confirmation Status. Date Site Ready To Start
Research Ethics Committee Reference Number Integrated Research Application System Number Submission Type Name of Trial Date of Receipt of Date of Valid Research Application First Patient Recruited? Date
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