A - Nonconfirmation Suspended by Sponsor B - D - Date site. C - Closed ready to start. Permissions. Sponsor delays ied. delayed/den.

Transcription

1 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 Suspended by B - D - Permissions C - Closed ready to start delayed/den by status delays ied F - No E - Staff Eligible G - No Availability Patients (No Patients issues patient Consented seen) H - Contracting Delays I-Rare disease J-Other Comments Sources of delay Effect of the Prevena Incision Management System on Sternal Wound Edge Perfusion in Patients undergoing CABG with Bilateral 1 16/SC/ Mammary Artery grafts Rituximab - a potential cure for the 2 16/NE/ young patient with Graves' disease Approval 15/02/2017 N 27/06/ /08/ /08/ /08/ /08/ /09/2016 Y Delay in delivery of equipment from supplier. Contracting delays by, further excaberated by incomplete funding information Approval N 07/04/ /10/ /09/ /02/ /02/2017 from. Y Very Low Dose Dexamethasone versus Placebo For the Treatment of Ventilator 3 16/NW/ Dependent Preterm Babies. Approval N 22/09/ /10/ /06/ /02/ /02/ /03/2017 Y Contracting delays by sponsor. Unilateral and Bilateral Neurodynamic Sliding Techniques as a Means of Treating Non-compressive Sciatic Leg Pain: A Pilot Study for a Randomised 4 16/YH/ Controlled Trial Approval 05/01/2017 N 27/06/ /10/ /10/ /10/ /10/ /10/2016 Y delay as a result of a protocol amendment - change of venue of intervention. The British Heart Foundation older patients with non-st Segment elevation myocardial infarction randomized interventional treatment 5 16/NE/ trial Approval 07/03/2017 N 01/09/ /09/ /08/ /10/ /10/ /10/2016 Y delayed confirmation of study open to. Study of the vascular response to percutaneous coronary intervention in patients with non-st-elevation acute approval process not completed in time. coronary syndromes using Also delays in shipment of study specific 6 16/NW/ intravascular blood sampling. Approval N 25/05/ /05/ /10/ /07/ /07/ /10/2016 Y Y catheter from manufacturer/funder. Randomised double-blind cross-over 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 7 16/SC/ metformin and a sulphonylurea. Approval N 08/03/ /12/ /07/ /12/ /01/ /02/2017 Y delayed confirmation of study open to A phase III, double-blind, randomized placebo-controlled 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- 8 16/EM/ GenE trial. Approval 17/02/2017 N 11/03/ /09/ /06/ /09/ /09/ /09/2016 Y A phase 4 double-blind, randomized, placebo-controlled, multi-center study to evaluate the efficacy, safety and tolerability of mirabegron in men with overactive bladder (OAB) symptoms while taking the alpha-blocker tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to 9 16/YH/ benign prostatic hyperplasia (BPH). Approval N 29/04/ /10/ /08/ /10/ /10/ /11/2016 Y delayed confirmation of study open to. A prospective multi-centre observational study to evaluate the capabilities of a portable magnetocardiograph (MCG) device to rule-out acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain 10 16/YH/ symptoms consistent with ACS. Approval 27/02/2017 N 01/02/ /12/ /12/ /01/ /02/ /02/2017 Y Contracting delays. delayed returning signed contracts SYSTEMS-2: A Randomised Phase II trial of standard versus dose escalated radiotherapy in the treatment of pain in 11 15/SS/ malignant pleural mesothelioma. Approval 22/02/2017 N 18/01/ /12/ /10/ /12/ /02/ /02/2017 Y Contracting / costing delays with Provider support service (Radiotherapy Physics) Provider A multi-center, randomized, doubleblind, placebo controlled, parallel group phase 2a study to assess the efficacy of RO in patients with primary 12 16/WM/ Sjogren s syndrome. Approval N 04/04/ /07/ /07/ /06/ /07/ /08/2016 Y A Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated 13 16/LO/ interstitial lung disease (SSc-ILD). Approval N 25/05/ /11/ /08/ /11/ /11/ /11/2016 Y. Strict patient eligibility criteria.

2 A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study to Assess the Efficacy and Safety of one or more Intradetrusor Treatments of 600 or 800 Units of DYSPORT for the Treatment of Urinary Incontinence in Subjects with Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple 14 16/NW/ Sclerosis. Approval N 03/05/ /10/ /07/ /10/ /10/ /10/2016 Y Provider staff availability Provider A 12-week, randomized, multi-center, double-blind, placebo-controlled, 3- arm, parallel-group, phase 3 trial to evaluate the efficacy and safety of 2 doses of AQX-1125 targeting the SHIP1 pathway in subjects with interstitial cystitits/bladder pain syndrome followed by a 2-arm, 14 or 15 16/EM/ week open label extension Approval N 12/10/ /01/ /12/ /02/ /02/ /02/2017 Y A Phase II single-arm, open-label monotherapy clinical trial of Pembrolizumab (MK-3475) in locally advanced/metastatic renal cell 16 16/NW/ carcinoma (mrcc) (KEYNOTE-427) Approval N 03/08/ /11/ /09/ /02/ /02/2017 Y delay in provision of study documentation. Trust provided budget feedback to sponsor in October 2016 and did not respond to this until January 2017 A Phase III randomised, controlled clinical trial of Pembrolizumab with or without platinum-based combination chemotherapy versus chemotherapy in subjects with advanced or metastatic 17 16/LO/ urothelial carcinoma. Approval N 28/07/ /11/ /11/ /11/ /11/2016 Y delayed confirmation of study open to A 6-month, multicenter, Phase 3, openlabel extension safety study of OTO- 104 given at 3-month intervals by intratympanic injection in subjects with 18 16/EE/ unilateral Meniere s disease Approval 06/02/2017 N 21/07/ /11/ /08/ /11/ /12/ /02/2017 Y delayed confirmation of study open to A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects with Relapsed/Refractory Aggressive B-Cell 19 16/WM/ Non Hodgkin Lymphoma. Approval 23/02/2017 N 29/07/ /10/ /10/ /10/ /11/ /11/2016 Y Y Diabetic Macular Oedema and Diode Subthreshhold Micropulse Laser (DIAMONDS): A pragmatic, multicentre, allocation concealed, prospective, randomised, non-inferiority 20 16/NI/ double masked trial Approval 29/03/2017 N 23/09/ /12/ /11/ /01/ /02/ /02/2017 Y Y delay in provision of equipment (scanner). Patients screened but no eligible patients. Contracting delays by and Lead Site, with participating sites. delayed site. Acceptability and tolerability of magnetic assisted capsule endoscopy 21 16/SC/ compared to gastroscopy A COMbined programme of exercise and dietary ADvice in men with castrate resistant prostate cancer /NE/ COMRADE trial Approval 09/03/2017 N 24/10/ /11/ /01/ /01/ /01/ /03/2017 Y Costing delays by Approval 15/03/2017 N 31/10/ /12/ /01/ /01/ /01/ /02/2017 Provider staff availability Provider Y Corneal cross-linking versus standard care in children with keratoconus; a randomised, multicentre, observermasked trial of efficacy and 23 16/LO/ safety. Approval 01/03/2017 N 25/08/ /09/ /08/ /11/ /11/ /12/2016 Y Costing delays by Provider Provider Treatment of poor-grade Subarachnoid 24 16/YH/ Haemorrhage Trial 2 - TOPSAT2 Approval N 08/09/ /10/ /07/ /11/ /12/ /12/2016 Y Y Y Rare disease group so not expected to recruit within 70 day benchmark. Other delays included contracting / costing delays with Provider support services. delayed site. Phase 2 Study: A Phase 2 Randomized, Double-Blinded, Placebo- Controlled Study to Evaluate the Cardiac and Renal Effects of 7 Day Treatment with Elamipretide in Patients Hospitalized with Severe 25 16/LO/ Congestion due to Heart Failure. Approval N/A 07/06/ /02/ /11/ /02/ /02/ /03/2017 Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating The Efficacy And Safety Of Oral Vadadustat For The Correction Of Anemia In Subjects With Non-Dialysis- Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT 26 16/NW/ CORRECTION) Approval N/A 13/10/ /03/ /11/ /03/ /03/2017

3 : A Phase 2 Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed Highrisk Diffuse Large B-Cell Lymphoma 27 16/YH/ (DLBCL) Approval N/A 25/01/ /01/ /01/ /02/ /02/ /02/2017 CV : An Open-label, 2x2 Fractorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrilation and Acute Coronary Syndrome or Percutaneous 28 16/EM/ Coronary Intervention Approval N/A 25/08/ /01/ /11/ /01/ /02/ /02/2017 A randomized, double-blind, doubledummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple 29 16/SC/ sclerosis. Approval N/A 05/09/ /02/ /10/ /02/ /03/2017 A Phase 2b, Randomised, Doubleblind, Placebo-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ in Subjects with Moderately 30 16/WM/ to Severely Active Crohn's Disease. Approval N/A 27/10/ /02/ /11/ /02/ /03/ /EM/ Thermal Comfort for Older People in Care Homes Approval N/A 04/01/ /01/ /01/ /02/ /02/ /03/2017 COMPLEEMENT-1: An open-label, multicentre, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (abc) with no prior hormonal therapy 32 16/EE/ for advanced disease Approval N/A 19/10/ /02/ /01/ /02/ /02/ /03/2017 Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with 33 16/LO/ haemophilia A Approval N/A 17/01/ /03/ /12/ /03/ /03/ /03/2017 Is it feasible to conduct a randomised controlled trial of pre-transplant exercise (prehabilitation) for multiple myeloma patients awaiting autologous 34 16/YH/ stem cell transplantation? Approval 14/10/2016 Y 05/07/ /09/ /09/ /09/ /09/ /09/2016 A Phase 1, randomised, open-label, 2- cohort, cross-over study to evaluate the pharmacokinetics, safety, and tolerability of a native oral testosterone formulation (DITEST) in the fed and fasted state and compared to testosterone undecanoate in adult men with primary or secondary 35 16/NW/ hypogonadism Approval 03/11/2016 Y 12/02/ /09/ /07/ /10/ /10/ /10/2016 Feasibility Study to Investigate the Potential Reduction of Bone Mineral Density Loss in Spinal Cord Injured 36 16/YH/ Patients Using Ekso Therapy Approval 08/12/2016 Y 26/06/ /10/ /10/ /10/ /10/ /10/2016 The Effect of Selenium Supplementation on Musculoskeletal Health in Older Women Double-blind, 37 16/YH/ randomised, placebo-controlled trial Approval 23/01/2017 Y 24/08/ /12/ /12/ /01/ /01/ /01/2017 BRAVO study 2: High grade Bladder cancer: A randomised controlled trial of Radical Cystectomy against intravesical immunotherapy A feasibility 38 16/YH/ study Approval 27/10/2016 Y 08/06/ /09/ /08/ /09/ /09/ /10/2016 Occupational Therapy Environmental 39 16/WS/ assessment and falls [OTIS] Multi-channel Stimulation for Post Stroke Spasticity (MUSTS): A randomised controlled cross over 40 16/YH/ feasibility trial. Approval 02/02/2017 Y 15/09/ /01/ /09/ /01/ /01/ /01/2017 Approval 11/11/2016 Y 01/04/ /09/ /05/ /09/ /09/ /09/2016 Comparing the usability of an electronic bladder diary and a paper bladder 41 16/NS/ diary: a two-way crossover study Approval 02/11/2016 Y 07/06/ /08/ /08/ /08/ /08/ /08/2016

4 Safety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus [BEAT 42 16/LO/ LUPUS] Approval 02/02/2017 Y 20/10/ /12/ /09/ /01/ /01/ /01/2017 The PodPAD Project - To evaluate the introduction of a public health approach to Peripheral Arterial Disease (PAD) using National Centre for Sport and 43 16/LO/ Exercise Medicine facilities. Approval 04/11/2016 Y 12/07/ /09/ /09/ /09/ /09/ /09/2016 The use of a virtual reality headset for the treatment of visual vertigo 44 16/YH/ symptoms. Approval 25/01/2017 Y 12/08/ /11/ /11/ /01/ /01/ /01/2017 A Randomized, Multicentre, Double- Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in combination with Atezolizumab or Atezolizumab-Placebo in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer who have Received Prior Trastuzumab and 45 16/EM/ Taxane Base Therapy [KATE-2] Elastography in the diagnosis of 46 16/YH/ chronic pancreatitis. PIONEER-5: Efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 diabetes and 47 16/EM/ moderate renal impairment. Approval 13/02/2017 Y 24/01/ /01/ /11/ /01/ /02/ /02/2017 Approval 07/12/2016 Y 22/07/ /10/ /11/ /11/ /11/ /11/2016 Approval 22/11/2016 Y 05/08/ /10/ /09/ /10/ /10/ /11/2016 A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib co-administered with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced 48 16/EE/ lung function impairment Approval 21/12/2016 Y 13/06/ /10/ /10/ /10/ /11/ /11/2016 A Phase III, open-label, multicenter, three-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab and atezolizumab monotherapy vs. regorafenib in patients with previously treated unresectable locally advanced or metastatic colorectal 49 16/SC/ adenocarcinoma. Approval 09/12/2016 Y 19/07/ /10/ /08/ /11/ /11/ /11/2016 A pilot study of the DAFNEplus (Dose Adjustment for Normal Eating) intervention for adults with type /WS/ diabetes Approval 15/03/2017 Y 27/10/ /03/ /11/ /03/ /03/ /03/2017 BALLAD: A TRIAL TO EVALUATE THE POTENTIAL BENEFIT OF ADJUVANT CHEMOTHERAPY FOR SMALL BOWEL 51 15/WS/ ADENOCARCINOMA (IRCI-002) Permission 31/03/ /06/2016 N Y Y. Very rare disease group. Feasibility of IBIS 3. An international breast intervention study investigating prevention of late recurrence in ER+ breast cancer survivors following /LO/ years of adjuvant treatment. Permission 22/03/2016 N Y delayed confirmation of study open to. Study still not yet open to recruitment An open randomised trial of the Arabin pessary to prevent preterm birth in twin pregnancy, with health economics and 53 14/SS/ acceptability STOPPIT-2. Permission 31/03/ /09/2016 N Y Contracting and costing delays by the TRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial 54 15/EM/ Hypertension Permission 29/03/ /01/2017 N Y Y. Rare disease group. CapaCiTY Study 2: Pragmatic Randomised Trial of Low versus High Volume Initiated Transanal Irrigation Therapy in adults with Chronic Local review not completed in time due to 55 15/LO/ Constipation Permission 29/03/ /02/2017 N Y confusion of community team involvement. Provider A double blind, randomized placebo controlled crossover multiple dose study of LJN452 to assess safety, tolerability and efficacy in patients with 56 16/LO/ primary bile acid diarrhea (pbad) Permission 29/03/ /09/2016 N Y Y Contracting and costing delays by resulting in local review not being completed in time. Furthermore, delayed site (ie green light) until 70 days.

5 A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial 57 16/SC/ Carcinoma. Permission 21/03/ /07/2016 N Y Y Y Local review not completed in time due to Study submitting substantial amendment to for approval during study set up at site. Delays experienced with approval for substantial amendment. Site was to recruit to new amendment. Also contracting delays by. This is an Permission study that was prevented from starting due to the need to wait for an amendment to be approved by before the study could commence. Multi-centre randomised control trial comparing the clinical and cost effectiveness of trans-foraminal epidural steroid injection to surgical microdiscectomy for the treatment of chronic radicular pain secondary to prolapsed intervertebral disc herniation: NErve Root Block VErsus Surgery 58 15/NW/ (NERVES). Permission 24/03/ /09/2016 N Y delay through research application amendment submission prior to permission. Site unable to provide Permission as site to set up study and commence recruitment based on amendment. Clinical evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for pulmonary artery denervation in patients with pulmonary 59 15/WM/ hypertension. (TROPHY) Permission 24/03/ /06/2016 Y A Randomized, double blind, placebocontrolled, phase 3 study to assess the efficacy and safety of KRN23 in adults with x-linked hypophosphotaemia 60 15/SC/ (XLH). Permission 24/03/ /05/2016 Y 61 16/EM/ The BAHA Attract System with Cochlear BAHA 5 SuperPower. Permission 24/03/ /05/2016 Y