PERFORMANCE IN INITIATING CLINICAL RESEARCHQ4 (2014-2015)

Research Ethics Committee Reference Number / Name of Trial / Date of Reciept of Valid Research Application / Date First Patient Recruited / Benchmark Met? / Reason For Delay
13/YH/0066 / Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) / 25/03/2015 / Within 70 days
14/WM/1211 / IMPRESS-AF: IMproved exercise tolerance in patients with PReserved Ejection fraction by Spironolactone on myocardial fibrosiS in Atrial Fibrillation / 19/03/2015 / 14/04/2015 / YES
14/LO/1842 / Enhanced Neoplasia Detection and Cancer Prevention in Chronic Colitis (ENDCaP-C)A Multicentre test accuracy study / 16/03/2015 / Within 70 days
14/LO/0100 / APIPPRA - Arthritis Prevention In The Pre-clinical Phase of RA with Abatacept / 09/03/2015 / Within 70 days
11/WM/0283 / HPV prevalence in the mouth and oropharynx of the tonsillectomy population OROMOUTH / 27/02/2015 / Within 70 days
14/LO/1428 / A phase 3 multi-centre double-masked randomised controlled trial of adjunctive intraocular and periocular steroid (triamcinolone acetonide)) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma; the adjunctive steroid combination in ocular trauma (ASCOT) trial / 23/02/2015 / 01/04/2015 / YES
14/NE/1143 / The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE Colitis - The ACCURE Trial Feasibility Study / 19/02/2015 / Within 70 days
13/EM/0459 / POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes / 04/02/2015 / Within 70 days
14/NW/1351 / Rehabilitation Enablement in Chronic Heart Failure (REACH HF). A multicentre parallel group randomised controlled trial with parallel economic and process evaluation to assess the clinical effectiveness and cost-effectiveness of the REACH HF manual for patients and caregivers. / 23/01/2015 / 10/02/2015 / YES
14/WM/0057 / Multicentre randomised controlled trial to compare the clinical and costeffectiveness 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) / 07/01/2015 / NO / Small patient population
13/EE/0339 / A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease (COMPASS - Cardiovascular OutcoMes for People using Anticoagulation StrategieS) / 07/01/2015 / 03/03/2015 / YES
13/LO/0145 / A multicentre phase III randomised controlled single masked clinical trial to test the clinical efficacy of LightMasks at
preventing dark adaptation in the treatment of early diabetic macular oedema (CLEOPATRA) / 17/12/2014 / 04/03/2015 / NO / Grren light for study to open not given until 10/02/015. First participant recruited within three weeks of green light
13/LO0651 / A randomised controlled trial of a biomarker-based exclusion of VAP to improve antibiotic stewardship. VAPrapid-2 / 08/12/2014 / NO / No suitable patients identified.
13/SC/0111 / FOCUS4. Molecular selection of therapy in colorectal cancer / 05/12/2014 / NO / Site still not activated. SIV now arranged for last week in April 2015
14/WM/0159 / Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study / 03/11/2014 / 17/12/2014 / YES
14/EM/1059 / 047 FIT - C-935788-047 A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura / 30/10/2014 / NO / Eligibility criteria prohibitive requiring very specific disease criteria.
14/NW/0327 / Effects of Glaucoma Surgery on Corneal Endothelial Cells - GICES / 10/10/2014 / 17/02/2015 / NO / Staffing issues at site
14/NW/0130 / RESPONSE: A randomised, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL) / 07/10/2014 / NO / Study closed at site due to resource issues
12/SS/0138 / REstart or STopAntithrombotics Randomised Trial (RESTART) / 30/09/2014 / 28/11/2014 / YES
13/EM/0395 / Treatment of Advanced Glaucoma Study (TAGS) / 01/10/2014 / NO / NO / No suitable patients identified.
13/EM/0398 / Phase II clinical trial investigating the use of epigallocatechin-3-gallate (Veregen) in the treatment of vulval intraepithelial neoplasia. EPIVIN trial (v 1.0) / 17/09/2014 / 13/10/2014 / YES
13/NW/0858 / Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) / 04/09/2014 / 22/10/2014 / YES
14/EE/0102 / ENSURE in AF (atrial fibrillation) study. A prospective, randomized, openlabel, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation / 04/09/2014 / 20/10/2014 / YES
12/WM/00335 / A pilot study for developing and evaluating a care pathway for cognitive problems after stroke (OCS-care) / 28/07/2014 / 28/08/2014 / YES
14/WS/0004 / Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732, & LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia ODYSSEY OLE / 22/07/2014 / 25/09/2014 / YES
14/WM/0083 / A Phase III Trial of Surgery versus Active Monitoring for Low Risk Ductal Carcinoma in Situ. The Low Risk DCIS Trial (LORIS). / 23/07/2014 / 14/08/2014 / YES
14/EE/0059 / Post-Market Multicentric Evaluation of the AQUESYS XEN Implant in Moderate Primary Open Angle Glaucoma Subjects. MS-001 Study / 18/07/2014 / 10/09/2014 / YES
14/EE/0102 / SPIRE 2: B1481038 Phase 3 multi-center, double-blind, randomized, Placebo-controlled, parallel group evaluation of the Efficacy, safety, and tolerability of pf-04950615, in reducing the Occurrence of major cardiovascular events in high risk Subjects / 10/07/2014 / NO / Sponsor delays: Green light to start the study not given until 18/12/2014. Eligibility criteria prohibitive requiring very specific disease criteria.
13/EM/0427 / MiQuit trial: Tailored text messages for pregnant women v1 / 03/07/2014 / 29/07/2014 / YES
12/LO/1168 / Subcutaneous Bortezomib, Cyclophosphamide and Rituximab (BCR) versus Fludarabine, Cyclophosphamide and Rituximab (FCR) for initial therapy of Waldenstrõmmacroglobulinaemia: a randomised phase II study. (R2W) / 25/06/2014 / 04/11/2014 / NO / Small patient population
14/SC/0032 / Phase 3, Multi-Centre, Double-Blind, Randomised, Placebo-controlled, Parallel Group Evaluation of the Efficacy, Safety and Tolerability of PF-04950615, in reducing the occurrence of major cardiovascular events in high risk subjects. SPIRE 1. / 19/06/2014 / No / NO / Sponsor delays: Green light to start the study not given until 18/12/2014. Eligibility criteria prohibitive requiring very specific disease criteria.
12/LO/1319 / A Phase 2 Study for Older Adults with Acute Lymphoblastic Leukaemia UKALL 60+ / 11/06/2014 / No / NO / Small patient population
14/EE/0032 / Pilot study: Finger prick fresh blood for treatment of chronic corneal ulcers, persistent epithelial defects and dry eyes. / 03/06/2014 / 08/08/2014 / YES
08/H1102/112 / TARDIS - Safety and efficacy of intensive versus guideline antiplatelet therapy in high risk patients with recent ischaemic stroke or transient ischaemic attack: a randomised controlled trial / 12/05/2014 / No / NO / Study closed at site due to lack of suitable patients presenting
14/SC/0100 / Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion / 09/05/2014 / 14/05/2014 / YES
13/LO/1320 / A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a FluocinoloneAcetonideIntravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye (pSivida) / 07/04/2014 / 19/05/2014 / YES

Page 1 of 4