PERFORMANCE IN INITIATING CLINICAL RESEARCH Q4 (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
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S a n d w e ll & W e s t B irm in g h a m H o s p ita ls
N H S T ru s t
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 STop Antithrombotics Randomised Trial
(RESTART) 30/09/2014 28/11/2014 YES
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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 Waldenstrõm macroglobulinaemia:
a randomised phase II study. (R2W)
25/06/2014 04/11/2014 NO Small patient population
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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 Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye (pSivida)
07/04/2014 19/05/2014 YES
