Sandwell & West Birmingham Hospitals
NHS Trust
PERFORMANCE IN INITIATING CLINICAL RESEARCH
Research
Ethics
Committee
Reference
Number
14/LO/1786
14/YH/0085
13/LO/1252
15/WA/0122
Q1 (2015-2016)
Date of
Reciept of
Valid
Research
Application
Name of Trial
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
FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib +
Rituximab
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
Clinical Investigation of the modified Rayner Monofocal Aspheric
600C (with axis marks) Intraocular Lens
Date First
Patient
Recruited
Benchmark
Met?
08/09/2015
Within 70
days
03/08/2015
Within 70
days
20/07/2015
09/09/2015
YES
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
13/NW/0280
INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS)
01/06/2015
Page 1 of 4
NO
14/07/2015
YES
Reason For Delay
No suitable patients
identified.
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
01/04/2015
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
Page 2 of 4
27/02/2015
21/07/2015
03/06/2015
20/08/2015
NO
No suitable patients
identified.
NO
Staff shortages
YES
NO
NO
14/04/2015
13/07/2015
24/06/2015
Restrictive eligibility criteria.
Rrotocol amendment has
been submitted to expand
the potential participant
population.
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
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
14/NE/1143
The feasibility of undertaking Appendicectomy to impact upon the
Clinical Course of UlceRativE Colitis - The ACCURE Trial Feasibility
Study
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
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
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)
Page 3 of 4
23/02/2015
01/04/2015
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
19/02/2015
17/12/2014
YES
NO
03/03/2015
04/03/2015
Small patient population
YES
NO
Grren light for study to open
not given until 10/02/015.
First participant recruited
within three weeks of green
light
NO
No suitable patients
consented. Availability of
staff at central laboratory has
meant some suitable
participants have not been
consented.
NO
Site not activate until 04 June
2015 (6 months after
submission).
13/LO0651
A randomised controlled trial of a biomarker-based exclusion of VAP
to improve antibiotic stewardship. VAPrapid-2
08/12/2014
13/SC/0111
FOCUS4. Molecular selection of therapy in colorectal cancer
05/12/2014
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,
Double-Blind, 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
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
Page 4 of 4
05/08/2015
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
No suitable patients
identified.