Sandwell & West Birmingham Hospitals
NHS Trust
PERFORMANCE IN INITIATING CLINICAL RESEARCH
Research Ethics
Committee
Reference
Number
Q4 (2014-2015)
Date of Reciept
of Valid
Research
Application
Name of Trial
Date First
Patient
Recruited
Benchmark
Met?
Within 70
days
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
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
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
27/02/2015
Within 70
days
14/LO/1428
14/NE/1143
13/EM/0459
The feasibility of undertaking Appendicectomy to impact upon
the Clinical Course of UlceRativE Colitis - The ACCURE Trial
Feasibility Study
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
23/02/2015
14/04/2015
01/04/2015
YES
YES
19/02/2015
Within 70
days
04/02/2015
Within 70
days
Page 1 of 4
Reason For Delay
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
13/LO0651
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)
A randomised controlled trial of a biomarker-based exclusion
of VAP to improve antibiotic stewardship. VAPrapid-2
13/SC/0111
10/02/2015
YES
NO
03/03/2015
YES
NO
Grren light for study to open
not given until 10/02/015.
First participant recruited
within three weeks of green
light
08/12/2014
NO
No suitable patients identified.
05/12/2014
NO
Site still not activated. SIV
now arranged for last week in
April 2015
17/12/2014
04/03/2015
FOCUS4. Molecular selection of therapy in colorectal cancer
14/WM/0159
14/EM/1059
14/NW/0327
14/NW/0130
12/SS/0138
Small patient population
Safety of Nasal Influenza Immunisation in Egg Allergic
Children - The SNIFFLE 2 Study
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
03/11/2014
Effects of Glaucoma Surgery on Corneal Endothelial Cells GICES
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)
10/10/2014
REstart or STop Antithrombotics Randomised Trial
(RESTART)
30/09/2014
17/12/2014
30/10/2014
17/02/2015
07/10/2014
Page 2 of 4
28/11/2014
YES
NO
Eligibility criteria prohibitive
requiring very specific
disease criteria.
NO
Staffing issues at site
NO
Study closed at site due to
resource issues
YES
13/EM/0395
Treatment of Advanced Glaucoma Study (TAGS)
01/10/2014
NO
NO
13/EM/0398
Phase II clinical trial investigating the use of epigallocatechin3-gallate (Veregen) in the treatment of vulval intraepithelial
neoplasia. EPIVIN trial (v 1.0)
17/09/2014
13/10/2014
YES
Assessment of an Education and Guidance programme for
Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
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
22/10/2014
YES
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
13/NW/0858
14/EE/0102
14/EE/0102
13/EM/0427
12/LO/1168
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
MiQuit trial: Tailored text messages for pregnant women v1
Subcutaneous Bortezomib, Cyclophosphamide and Rituximab
(BCR) versus Fludarabine, Cyclophosphamide and Rituximab
(FCR) for initial therapy of Waldenstrõm macroglobulinaemia:
a randomised phase II study. (R2W)
10/07/2014
NO
03/07/2014
29/07/2014
YES
25/06/2014
04/11/2014
NO
Page 3 of 4
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.
Small patient population
14/SC/0032
Phase 3, Multi-Centre, Double-Blind, Randomised, Placebocontrolled, 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
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
Ocriplasmin for Vitreomacular Traction/Symptomatic
Vitreomacular Adhesion
09/05/2014
14/05/2014
YES
07/04/2014
19/05/2014
YES
08/H1102/112
14/SC/0100
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)
Page 4 of 4
Study closed at site due to
lack of suitable patients
presenting