PERFORMANCE IN INITIATING CLINICAL RESEARCHQ3 (2015-2016)

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/SC/0645 / PHOENIX Pre-eclampsia in Hospital: Early induction or expectant management / 07/12/2015 / 26/02/2016 / NO / No suitable patients identified.
11/SS/0100 / FOCUS A multicentre, randomised trail to establish the effect(s) of routine administration of Fluoxetine for six months in patients with a recent stroke / 06/12/2015 / 05/01/2016 / YES
14/SS/1096 / RAPID-CTCA Trial. Rapid Assessment of Potential Ischaemic Heart Disease with CTCA. The role of early CT Coronary Angiography in the evaluation, intervention and outcome of patients presenting to the Emergency Department or Medical Assessment Unit with suspected or confirmed Acute Coronary Syndrome / 15/11/2015 / 08/12/2015 / YES
14/LO/1786 / CapaCiTY study 1. Randomised Trial of Habit Training vs. Habit Training with Direct Visual Biofeedback in Adults with Chronic Constipation. Chronic Constipation Treatment pathwaY, study 1 / 08/09/2015 / 08/12/2015 / NO / No suitable patients identified.
14/YH/0085 / FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab / 03/08/2015 / 01/12/2015 / NO / Several patients screened failed on a single blood result.
13/LO/1252 / The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum / 20/07/2015 / 09/09/2015 / YES
15/WA/0122 / Clinical Investigation of the modified Rayner Monofocal Aspheric 600C (with axis marks) Intraocular Lens / 01/07/2015 / 24/07/2015 / YES
14/LO/0203 / CLARITY - Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy. A Multicentre, Phase Iib, Randomised, Active-Controlled Clinical Trial / 01/07/2015 / 09/09/2015 / YES
13/EM/0239 / RESPITE - Remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour: a randomised controlled trial / 17/06/2015 / 08/07/2015 / YES
12/LO/0078 / RESPECT-Meso. A multicentre non-blinded randomised controlled trial to assess the impact of Regular Early SPEcialist symptom Control Treatment on quality of life in malignant Mesothelioma / 01/06/2015 / NO / No suitable patients identified.
13/NW/0280 / INjectionversusSplinTinginCarpalTunnelSyndrome(INSTinCTS) / 01/06/2015 / 14/07/2015 / YES
10/H0302/51 / TB-REACH Virtually Observed Therapy (VOT) versus Directly Observed Therapy (DOT) / 20/04/2015 / 21/07/2015 / NO / No suitable patients identified.
14/EM/0121 / RITUXILUP - An open label randomised multicentre controlled trial of RITUXImab and mycophenolatemofetil (MMF) without oral steroids for the treatment of LUPus nephritis / 15/04/2015 / NO / Staff shortages
14/LO/1043 / LEAVO. A Multicentre Phase II Double-masked Randomised Controlled Non-Inferiority Trial Comparing the Clinical and Cost Effectiveness of Intravitreal Therapy with Ranibizumab (Lucentis) vs Aflibercept (Eylea) vs Bevacizumab (Avastin) for Macular Oedema due to Centre Retinal Vein Occlusion (CRVO). / 13/04/2015 / 03/06/2015 / YES
14/WM/0093 / FOAM. A phase III randomised study of folic acid supplementation in the management of menopausal symptoms in cancer survivors and healthy postmenopausal women / 01/04/2015 / 20/08/2015 / NO / Restrictive eligibility criteria. Protocol amendment has been submitted to expand the potential participant population.
13/YH/0066 / Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) / 25/03/2015 / NO / No suitable patients identified.
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 / 13/07/2015 / NO / Green light for study to open not given until 12 May 2015. First participant recruited within 70 days of green light
14/LO/0100 / APIPPRA - Arthritis Prevention In The Pre-clinical Phase of RA with Abatacept / 09/03/2015 / NO / Staff shortages
11/WM/0283 / HPV prevalence in the mouth and oropharynx of the tonsillectomy population OROMOUTH / 27/02/2015 / 24/06/2015 / NO / Difficulties experienced in obtaining information about potential participants prior to tonsillectomy taking place
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 / NO / Study closed at site due to PI leaving the Trust and no replacement PI being identified.
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 / 07/05/2015 / NO / Restrictive eligibility criteria which were amended in April 2015 and resulted in rapid recruitment of the first participant.
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 costeffectivenessof 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

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