Sandwell & West Birmingham Hospitals
NHS Trust
PERFORMANCE IN INITIATING CLINICAL RESEARCH
Research
Ethics
Committee
Reference
Number
Q1 (2015-2016)
Date of
Reciept of
Valid
Research
Application
Name of Trial
Date First
Patient
Recruited
Benchmark
Met?
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
Within 70
days
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
Within 70
days
13/NW/0280
INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS)
01/06/2015
Within 70
days
10/H0302/51
TB-REACH Virtually Observed Therapy (VOT) versus Directly Observed
Therapy (DOT)
20/04/2015
14/EM/0121
RITUXILUP - An open label randomised multicentre controlled trial of
RITUXImab and mycophenolate mofetil (MMF) without oral steroids for
the treatment of LUPus nephritis
15/04/2015
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
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
Page 1 of 4
01/04/2015
21/07/2015
03/06/2015
Reason For Delay
NO
No suitable patients identified.
NO
Staff shortages
YES
NO
Restrictive eligibility criteria.
Rrotocol 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
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/LO/1842
Enhanced Neoplasia Detection and Cancer Prevention in Chronic Colitis
(ENDCaP-C)A Multicentre test accuracy study
16/03/2015
14/LO/0100
APIPPRA - Arthritis Prevention In The Pre-clinical Phase of RA with
Abatacept
09/03/2015
11/WM/0283
HPV prevalence in the mouth and oropharynx of the tonsillectomy
population OROMOUTH
27/02/2015
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
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
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
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
Page 2 of 4
NO
14/04/2015
No suitable patients identified.
YES
NO
Grren light for study to open not
given until 12 May 2015. First
participant recruited within 70 days
of green light
NO
Staff shortages
24/06/2015
NO
Difficulties experienced in
obtaining information about
potential participants prior to
tonsillectomy taking place
01/04/2015
YES
13/07/2015
NO
Study closed at site due to PI
leaving the Trust and no
replacement PI being identified.
07/05/2015
NO
Restrictive eligibility criteria which
were amended in April 2015 and
resulted in rapid recruitment of the
first participant.
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
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
NO
Small patient population
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 consented.
Availability of staff at central
laboratory has meant some
suitable participants have not been
consented.
13/SC/0111
FOCUS4. Molecular selection of therapy in colorectal cancer
05/12/2014
NO
Site not activate until 04 June 2015
(6 months after submission).
14/WM/0159
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The
SNIFFLE 2 Study
03/11/2014
14/EM/1059
047 FIT - C-935788-047 A Phase 3, Multi-Center, Randomized, DoubleBlind, Placebo-Controlled, Study of Fostamatinib Disodium in the
Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
30/10/2014
14/NW/0327
Effects of Glaucoma Surgery on Corneal Endothelial Celss - GICES
10/10/2014
14/NW/0130
RESPONSE: A randomised, double blind, multi-center, placebocontrolled 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
Page 3 of 4
17/12/2014
17/02/2015
YES
NO
Eligibility criteria prohibitive
requiring very specific disease
criteria.
NO
Staffing issues at site
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
13/EM/0395
Treatment of Advanced Glaucoma Study (TAGS)
01/10/2014
15/04/2015
NO
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
13/EM/0427
MiQuit trial: Tailored text messages for pregnant women v1
03/07/2014
Page 4 of 4
NO
29/07/2014
YES
No suitable patients identified.
Sponsor delays: Green light to
start the study not given until
18/12/2014. Eligibility criteria
prohibitive requiring very specific
disease criteria.