Performance in Initiating Clinical Research

Transcription

1 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 Date of Receipt of Valid Research Application Date of First Patient Recruited Benchmark Met Comments Reasons for delay correspond to: 14/SS/ 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) 14/WA/ Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome (AML19) 14/EE/ 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) 15/LO/ 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) 14/WM/ 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 infrapopliteal arterial disease: Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-2) 11/01/ /06/2016 No All eligible patients reporting period approached. Site target of 2 patients in total. 12/01/ /02/2016 Yes Benchmark Met 15/01/2016 No No eligible patients seen in the reporting period. Site target of 2 patients in total. 01/02/ /02/2016 Yes Benchmark Met 15/02/2016 No No eligible patient seen within 70 date target of 5.

2 15/EM/ A phase III randomised, open-label, multi-centre, global study of MEDI4736 in combination with Tremelimumab versus standard of care in the treatment of first-line recurrent or metastatic squamous cell head and neck cancer patients (KESTREL) 14/NW/ 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) 09/02/ /04/2016 Yes Benchmark Met 22/02/ /03/2016 Yes Benchmark Met 14/NW/ The Bedside Evaluation of Sensitive Troponin (BEST) study 02/03/ /03/2016 Yes Benchmark Met 15/LO/ : 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, active-controlled, parallel-group, multicentre, multi-national, four-armed trial (PIONEER 3) 14/WA/ 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) 14/YH/ GALACTIC: GA-101 (obinutuzumab) monoclonal Antibody as Consolidation Therapy in CLL 14/NE/ UK FROST (United Kingdom Frozen Shoulder Trial: Multi-centre, 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) 15/EM/ 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 ) 15/03/ /03/2016 Yes Benchmark Met 18/03/ /04/2016 Yes Benchmark Met 31/03/ /09/2016 No No eligible patients total target of 6 14/04/ /04/2016 Yes Benchmark Met 18/04/ /08/2016 No No eligible patient target of 4 total

3 15/NW/ 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) 15/NW/ 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) 14/LO/ Improving radical treatment through MRI evaluation of pelvic sigmoid cancers (the IMPRESS trial) 16/WM/ Supporting adults with Type 1 Diabetes to undertake exercise; Developing and piloting an education programme for exercise in Type 1 Diabetes (EXTOD Education) 29/03/ /06/2016 No Site not given green light by Sponsor until 02/06/2016. Drug supplies took 2 weeks to arrive on site following green light. Discussions regarding contract wording regarding provision of standard of care insulin were ongoing post VRA, and led to the VRA to NHSP timeframe exceeding 30 days. 29/03/ /06/2016 No Site not given green light by Sponsor until 02/06/2016. Drug supplies took 2 weeks to arrive on site following green light. Discussions regarding contract wording regarding provision of standard of care insulin were ongoing post VRA, and led to the VRA to NHSP timeframe exceeding 30 days. 16/05/2016 No No eligible patient target of 5. 05/05/ /06/2016 Yes Benchmark met

4 15/LO/ 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 11/LO/ TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer 16/06/ /12/2016 No No eligible patient target of 3. 16/06/ /09/2016 No Site has consented 17 patients to initial screening, screening take 6 weeks and then a further 28 day period to confirm eligibility. 14/SW/ Long Term investigative Follow-up in TrialNet (LIFT TN16) 30/06/2016 No No eligible patient target of 1. 15/NS/ 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) 15/SC/ 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 who are in complete 15/LO/ 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 surg 14/06/2016 No No eligible patient target of 4. 16/06/2016 No No eligible patient target of 2. 27/06/ /08/2016 Yes Benchmark Met

5 HRA Process Site Confirmation of Capacity and Capability Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial 16/LO/ External pilot study to inform the design and conduct of the Fluids in Shock (FiSh) Trial 16/EM/ Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH - AFNET 6) First Patient Recruited? Date of First Patient Recruited Benchm ark Met Invited Selected HRA Approval Date Confirmed By Sponsor Confirmed Ready To Start Comments Yes 28/11/2016 No 28/04/ /06/ /06/ /06/ /08/ /08/2016 Delayed while larger referral site opened No No 13/12/ /05/ /05/ /05/ /10/ /10/2016 No eligible patient seen in the 70 day reporting period 16/SW/ CENTERA No No 02/03/ /10/ /10/2016 Equipment delayed 16/SC/ TriMaster: Randomised Double-Blind Crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as third line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on dual therapy with metformin and a sulphonylurea No Within 70 Days 11/08/ /12/ /07/ /12/ /12/2016 Within 70 days

6 15/EM/ IRONMAN No No 12/04/ /09/ /07/2016 ETCs identified, ongoing discussions regarding funding of ETCs 16/WA/ Feasibility study evaluating a prognostic model for blunt chest trauma No Within 70 Days 05/10/ /11/ /11/2016 Within 70 days 16/NW/ Myeloma XII (ACCoRd trial) Version 1.0 No Within 70 Days 29/07/ /10/ /10/2016 Within 70 days PLEASE NOTE: The data detailed above in the HRA process - Site confirmation of Capability and Capacity section only includes clinical trials that have only ever received HRA approval and therefore the data does not detail all trials that have been opened at this site since 01/04/2016.