Performance in Initiating Clinical Research Q4 2015/16

Transcription

1 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 Date of First Patient Recruited Benchmark Met Delay Reasons for delay correspond to: 14/LO/ ON-EPIC Oral nitrate supplementation to enhance pulmonary rehabilitation in chronic obstructive pulmonary 30/03/ /05/2015 Yes 14/NE/ A randomised, double-blind, phase 2 study of Ruxolitinib or placebo in combination with Capecitabine in subjects with advanced or metastatic HER2-Negative Breast Cancer (INCYTE) 13/04/ /05/2015 Yes 10/H0715/ A Randomised Multicentre Accelerated Radiotherapy Study of Dose Escalated Intensity Modulated Radiotherapy vs Standard Dose Intensity Modulated Radiotherapy in Patients Receiving Treatment for Locally Advanced Laryngeal and Hypopharyngeal Cancers (ART DECO) 16/04/2015 No 13/LO/ Neonatal and Paediatric Pharmacokinetics of Antimicrobials study (NAPPA) 17/04/ /05/2015 Yes 14/SW/ CTLA-4 Ig (Abatacept) for prevention of abnormal glucose tolerance and diabetes in relative at-risk for type 1 diabetes mellitus (TRIALNET TN18) 17/04/ /07/2015 No Rare Disease

2 13/ES/ /YH/ /LO/ /WA/ /SC/ A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium (NiCCC Trial) FLAIR (CLL10): Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab A phase IV multicentre, open-label, noninterventional study of postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer treated with Afinitor? (everolimus [RAD001]) in combination with exemestane, after progression following therapy with a non-steroidal aromatase inhibitor (BOUDICA) A Trial for Older Patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome (AML18) Effectiveness of progesterone to prevent miscarriage in women with early pregnancy bleeding: A randomised placebo-controlled trial (PRISM Trial: Progesterone In Spontaneous Miscarriage trial) 23/04/ /09/2015 No Rare Disease 19/06/ /12/2015 No Rare Disease 23/06/ /07/2015 Yes 23/06/ /08/2015 Yes 24/06/ /08/2015 Yes 14/SW/ A feasibility study and pilot RCT to establish methods for assessing the acceptability and clinical and cost-effectiveness of enhanced psychological care (EPC) in cardiac rehabilitation services for with new onset depression compared with treatment as usual: CADENCE Study 15/07/2015 No seen

3 14/YH/ A randomised phase III trial comparing radical hysterectomy and pelvic node dissection versus simple hysterectomy and pelvic node dissection in with low-risk early-stage cervical cancer (SHAPE) 07/07/ /01/2016 No 14/YH/ The influence of anaesthetic depth on patient outcome after major surgery (The BALANCED Anaesthesia Study) 23/07/ /02/2016 No seen 15/SC/ Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill (POPPI) cluster-randomised controlled trial 10/08/ /09/2015 Yes 15/SC/ Randomised Ambulatory Management of Primary Pneumothorax (RAMPP) 13/08/2015 No seen 13/SS/ /EM/ A randomised, double-blind, placebo controlled trial of the effectiveness of low dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of chronic obstructive pulmonary (TWICS) A multi-centre study to evaluate safety and tolerability in with chronic heart failure and reduced ejection fraction from PARADIGM- HF receiving open label LCZ696 (PARADIGM-HF Open Label) 10/09/ /12/2015 No Rare Disease 22/09/ /11/2015 Yes 15/NW/ Comprehensive mouth-care to reduce Postoperative PneumoniA (CUPPA) 09/09/ /01/2016 No No 15/WS/ A Randomised, Double-blind, Event-driven, Multicentre Study Comparing the Efficacy and Safety of Rivaroxaban with Placebo for Reducing 15/09/2015 No No

4 the Risk of Death, Myocardial Infarction or Stroke in Subjects with Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure (COMMANDER-HF) 14/SC/ Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest (AIRWAYS-2) 14/04/ /07/2015 No seen 14/SC/ A pragmatic multi-centre, blinded, randomised placebo-controlled trial comparing Platelet Rich Plasma injection (PRP) to placebo (imitation) injection in adults with Achilles tendon rupture. Two sub-studies are embedded within the main study to contribute to the understanding of the PRP mechanism in tendon healing (PATH2) 28/09/ /01/2016 No No 14/LO/ 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) 30/09/2015 No 15/SW/ PREMISE: A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated with Enzalutamide Treatment in with metastatic Castration Resistant ProState CancEr (mcrpc) 01/10/ /10/2015 Yes 12/WA/ Palliative radiotherapy in addition to selfexpanding metal stent for improving outcomes of dysphagia and survival in advanced 24/09/ /01/2016 No

5 oesophageal cancer (ROCS) 14/LO/ Planning treatment for oesophago-gastric cancer: A randomised maintenance therapy trial (PLATFORM Trial) 09/10/ /03/2016 No 14/WS/ Multicentre, randomised, double-blind, doubledummy, active-comparator, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in with a recent Embolic Stroke of Undermined Source (ESUS), comparing rivaroxaban 15mg once daily with aspirin 100mg (NAVIGATE ESUS) 23/10/ /01/2016 No No 15/WA/ Prevalence of Lower Urinary tract Symptoms in Hip and Knee Replacement Study (PLUS Study) 22/10/ /11/2015 Yes 14/YH/ A phase II randomised, double-blind, placebocontrolled 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) 13/11/2015 No 14/SW/ A phase II randomised, double-blind, placebocontrolled 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 13/11/2015 No

6 17096) 14/EE/ A Phase III Randomised Trial of MK (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer 20/11/ /12/2015 Yes 11/WM/ 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 18/11/ /12/2015 Yes 14/SC/ A phase III double-blind, placebo controlled, randomised trial assessing the effects of aspirin on recurrence and survival after primary therapy in common non-metastatic solid tumours (ADD-ASPIRIN) 25/11/ /02/2016 No No 14/ES/ A randomised phase II/III study to assess the efficacy of trametinib (GSK ) in with recurrent or progressive low-grade serous ovarian cancer or peritoneal cancer (LOGS) 02/12/ /03/2016 No No, Rare 15/YH/ A 21-week, open-label, randomised, controlled, parallel-group, multi-centre study evaluating the efficacy and safety of HOE901-U300 administered according to a device-supported treat-to-target regimen routine titration in T2DM (AUTOMATIX) 11/12/ /02/2016 Yes 14/SS/ Randomised, double-blind, multicentre, phase III trial evaluating the safety and benefit of adding 11/01/2016 No No,

7 Everolimus to adjuvant hormone therapy in women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of after receiving at least 1 year of adjuvant hormone therapy (UNIRAD) Rare 14/WA/ Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome (AML19) 12/01/ /02/2016 Yes 14/EE/ A phase 2 randomised, double-blind, placebocontrolled, trial of MHAA4549A, a monoclonal antibody, in combination with Oseltamivir versus Oseltamivir for treatment of severe Influenza A infection (INFLUENZA-A) 15/01/2016 No No, Rare 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) 01/02/ /02/2016 Yes 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 infra-popliteal arterial : Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-2) 15/02/2016 Within 70 Days 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 (KESTREL) 09/02/2016 Within 70 Days

8 14/NW/ /NW/ /LO/ 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) The Bedside Evaluation of Sensitive Troponin (BEST) study 4222: 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, multi-centre, multi-national, four-armed trial (PIONEER 3) 22/02/ /03/2016 Yes 02/03/ /03/2016 Yes 15/03/ /03/2016 Yes 14/WA/ A randomised, double-blind, placebo controlled, phase II study of fulvestrant with or without the addition of vandetanib as treatment for with metastatic breast cancer resistant to aromatase inhibitor therapy (FURVA) 18/03/2016 Within 70 Days