PERFORMANCE IN INITIATING CLINICAL RESEARCH Q1 (2015-2016) Research Date of Ethics Reciept of Date First Benchmark Committee Name of Trial Valid Patient Reason For Delay Met? Reference Research Recruited Number Application CapaCiTY study 1. Randomised Trial of Habit Training vs. Habit Within 70 14/LO/1786 08/09/2015 Training with Direct Visual Biofeedback in Adults with Chronic days Constipation. Chronic Constipation Treatment pathwaY, study 1 FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib + Within 70 14/YH/0085 03/08/2015 days Rituximab The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of 13/LO/1252 20/07/2015 09/09/2015 YES MEK162 vs. Chemotherapy in Patients with Physician’s Choice Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum 15/WA/0122 01/07/2015 24/07/2015 YES Clinical Investigation of the modified Rayner Monofocal Aspheric 600C (with axis marks) Intraocular Lens CLARITY - Clinical Efficacy and Mechanistic Evaluation of 14/LO/0203 01/07/2015 09/09/2015 YES Aflibercept for Proliferative Diabetic Retinopathy. A Multicentre, Phase Iib, Randomised, Active-Controlled Clinical Trial RESPITE - Remifentanil intravenous patient controlled analgesia 13/EM/0239 (PCA) versus intramuscular pethidine for pain relief in labour: a 17/06/2015 08/07/2015 YES randomised controlled trial RESPECT-Meso. A multicentre non-blinded randomised controlled No suitable patients 12/LO/0078 trial to assess the impact of Regular Early SPEcialist symptom 01/06/2015 NO identified. Control Treatment on quality of life in malignant Mesothelioma 13/NW/0280 INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS) 01/06/2015 14/07/2015 YES
PERFORMANCE IN INITIATING CLINICAL RESEARCH Q1 (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 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 Within 70 days 14/YH/0085 FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab 03/08/2015 Within 70 days 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 INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS) 01/06/2015 14/07/2015 YES
PII-Q22015-16.docx