Deadline Date
Date Submitted
Type
NHS provider
31/01/2014
29/01/2014
Performance in Initiating
Norfolk and Norwich University Hospitals NHS
Foundation Trust
Date of
Receipt of
Date of NHS First Patient
Valid
Permission Recruited?
Research
Application
Duration
Date of
between VRA
First Patient
and NHS
Recruited
Permission
Duration
Duration between
between
NHS Permission
Benchmark Met
VRA and
and First Patient
First Patient
03/12/2013
46
APermissions
delayed/denie
d
BSuspend
ed by
sponsor
CDClosed
Sponsor
by
Delays
sponsor
E - Staff F - No
availabilit patients
y issues seen
G - No
Hpatients
I - Rare
JContracti
consente
diseases Other
ng delays
d
Reasons for
delay correspond
to:
Id
Research Ethics Committee
Reference Number
Name of Trial
27712
12/LO/0515
Optimal Personalised Treatment of early breast cancer
11/10/2013
using Multi-parameter Analysis
18/10/2013
Yes
27713
13/SC/0136
Everolimus in postmenopausal ER + Metastatic Breast
15/11/2013
Cancer Patients
13/12/2013
No
27714
13/SC/0140
Evaluation of Brochiectasis Empowerment Tool (BET)
03/05/2013
03/05/2013
Yes
07/05/2013
0
4
4
Yes
27715
13/SC/0116
Daily activity in patients with interstitial lung disease
02/05/2013
08/05/2013
Yes
20/08/2013
6
104
110
No
27716
13/LO/0219
A Phase 2, Randomized, DoubleBlind,
PlaceboControlled, MultiCenter Study to Assess the
Efficacy and Safety of GS6624 in Subjects with
Idiopathic Pulmonary Fibrosis (RAINIER)
25/10/2013
28/10/2013
Yes
21/11/2013
3
24
27
Yes
27717
12/YH/0319
Br002: Multicenter Study Novilase Ablation of Small
Breast Cancers
17/06/2013
24/06/2013
Yes
31/10/2013
7
129
136
No
27718
12/LO/1498
A Phase II, Multicenter, Randomized, Double-blinded,
Parallel-Group, Placebo-Controlled Study to Investigate
the Efficacy and Safety of R02602522 add to the
19/03/2013
Background Therapy of Acetylcholinesterase Inhibitors
Donezepill or Rivastigmine in Patients with Moderate
Severity Alzheimer?s Disease (Mayflower Road)
22/03/2013
Yes
30/11/2013
3
253
256
No
Y
Neither
27719
11/SS/0092
Trial of BIBW 2992 in suspected mutant EGFR lung
cancer patients unfit for chemotherapy
10/12/2012
08/01/2013
No
29
No
Y
Neither
25/06/2013
23/07/2013
No
28
No
27720
12/NW/0629
27721
12/NW/0670
27722
12/NI/0129
27723
A Phase 3 Randomized, Open-Label Study of
Ponatinib versus Imatinib in Adult Patients with Newly
Diagnosed Chronic Myeloid Leukemia in Chronic
Phase.
20110232 - AMG 181 in Subjects with Moderate to
Severe Crohn's Disease
ActiveControlled Study of CB183,315 in Patients with
CDAD
7
53
28
13/02/2013
Yes
Please Select...
Within 70 Days
42
Neither
Please Select...
Y
NHS Provider
Please Select...
Y
02/01/2013
02/01/2013
Yes
06/08/2013
No
15
No
11/LO/1570
Cyclophosphamide, doxorubicin, vincristine and
prednisolone (CHOP) versus gemcitabine, cisplatin and
methyl prednisolone (GEMP) in the first line treatment 21/08/2013
Of Tcell Lymphoma, a multicentre randomised phase II
study
17/09/2013
No
27
No
Y
27724
12/SW/0361
COMBI-AD: A phase III randomized double blind study
of dabrafenib (GSK2118436) in COMBInation with
trametinib (GSK1120212) versus two placebos in the 18/01/2013
ADjuvant treatment of high-risk BRAF V600 mutationpositive melanoma after surgical resection.
08/02/2013
Yes
No
Y
27725
13/YH/0174
16/10/2013
11/11/2013
No
27726
13/WM/0202
06/09/2013
01/10/2013
Yes
27/11/2013
27727
13/LO/0002
A Phase 3 Randomised, Controlled Study Evaluating
the Efficacy and Safety of GS-1101 (CAL-101) in
Combination with Ofatumumab for Previously Treated
Chronic Lymphocytic Leukaemia
22/03/2013
22/04/2013
Yes
27728
12/SC/0570
CFTY720D2406: long-term observational fingolimod
study -Passage
13/02/2013
26/02/2013
27729
12/LO/1889
Open-label, single-arm extension study to the doubleblind, randomized, multicenter, placebo-controlled,
parallel-group study comparing the efficacy and safety
12/04/2013
of 0.5 mg FTY720 administered orally once daily
versus placebo in patients with primary progressive
multiple sclerosis
27730
10/H1002/80
SCIPI- Subcutaneous Insulin: Pumps or Injections
27731
27732
94
25
57
82
No
10/07/2013
31
79
110
No
Yes
21/03/2013
13
23
36
Yes
13/05/2013
Yes
17/12/2013
31
218
249
No
16/09/2013
14/10/2013
No
10/MRE00/66
GWCA0962: A double blind, randomized,
placebocontrolled, parallel group study of Sativex
oromucosal spray (Sativex?; Nabiximols) as adjunctive
therapy in relieving uncontrolled persistent chronic pain 05/04/2013
in patients with advanced cancer, who experience
inadequate analgesia during optimized chronic opioid
therapy.
12/04/2013
Yes
16/09/2013
7
157
164
No
11/LO/1857
Pharmacokinetics and safety of Meropenem in infants
below 90 days of age (inclusive) with probable and
09/05/2013
confirmed meningitis: A European Multicenter Phase II
Trial (NeoMero 2)
16/05/2013
Yes
16/09/2013
7
123
130
No
27733
12/MW/0149
27734
10/H0906/11
27735
13/EE/0292
27736
11/LO/1019
CHF 5633 in Preterm Neonates with Respiratory
Distress Syndrome
Donepezil in Early Dementia Associated with
Parkinson's Disease
Blueberry anthocyanin, insulin resistance, vascular
health & cognition
Persistent Pulmonary Hypertension of the newborn
Protocol AC-052-391
26
No
29/10/2013
30/10/2013
Yes
14/12/2013
1
45
46
Yes
08/03/2013
15/03/2013
Yes
27/11/2013
7
257
264
No
20/11/2013
16/12/2013
Yes
13/01/2014
26
28
54
Yes
14/05/2013
16/05/2013
No
2
Y
Study terminated early due to arterial
thrombotic events linked to ponatinib
Y
on hold due to dispensing arrangments
Both
of study drug
No
Neither
Please Select...
Y
No
28
Neither
Yes
73
M13375,Adalimumab, nonradiographic axial
Spondyloarthritis study
Leucopatch in Diabetic Foot Ulcer
21
42
Y
22/07/2013
22/04/2013
0
Comments
Y
Neither
Neither
Y
Neither
Y
Y
Both
Y
Neither
Please Select...
Y
Y
Study is an extension study 1st patient
to be transferred on to the extension
study was not eliagble to join until the
17/12/2013
Neither
Both
Y
Neither
Y
Neither
Please Select...
Y
Neither
Please Select...
Y
Y
Y
Neither
Id
Research Ethics Committee
Reference Number
Name of Trial
Date of
Receipt of
Date of NHS First Patient
Valid
Permission Recruited?
Research
Application
Duration
Date of
between VRA
First Patient
and NHS
Recruited
Permission
Duration
Duration between
between
NHS Permission
Benchmark Met
VRA and
and First Patient
First Patient
27737
12/LO/1109
A Prospective Randomised Phase III Study of
Observation Versus Screening MRI And PreEmptive
Treatment in Castrate Resistant Prostate Cancer
Patients With Spinal Metastasis
30/01/2013
15/02/2013
Yes
16/10/2013
243
27738
11/SC/0528
A phase III multicentre trial of weekly induction
chemotherapy followed by standard chemoradiation
versus standard chemoradiation alone in patients with
locally advanced cervical cancer
29/08/2013
09/09/2013
No
27739
13/LO/0365
27740
13/SC/0027
27741
13/SC/0174
27742
12/NE/0087
27743
11/SC/0458
27744
12/NW/0514
27745
07/H1306/127
27746
13/EE/0319
27747
12/WM/0187
27748
27749
Levosimendan for the Prevention of Acute Organ
03/10/2013
Dysfunction in Sepsis (LeoPARDS)
NUC-3/PSC - Nor-ursodeoxycholic acid vs. Placebo in
11/04/2013
PSC
16
259
11
BSuspend
ed by
sponsor
CDClosed
Sponsor
by
Delays
sponsor
E - Staff F - No
availabilit patients
y issues seen
No
No
No
G - No
Hpatients
I - Rare
JContracti
consente
diseases Other
ng delays
d
Y
Comments
Reasons for
delay correspond
to:
Neither
Y
Both
04/12/2013
No
22/04/2013
Yes
21/08/2013
11
121
132
No
Y
Neither
A Phase 2b, Dose-Ranging, Randomized, DoubleBlind, Placebo-Controlled Trial Evaluating the Safety
and Efficacy of GS-6624, a Monoclonal Antibody
05/07/2013
Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with
Primary Sclerosing Cholangitis (PSC).
29/07/2013
Yes
23/10/2013
24
86
110
No
Y
Neither
MOT115816 Gastroparesis and Parkinson's disease
15/05/2013
21/05/2013
Yes
30/10/2013
6
162
168
No
13/03/2013
22/03/2013
No
9
No
02/05/2013
01/07/2013
No
60
No
Y
No
Y
A randomised phase 2 study of paclitaxel with or
without GSK1120212 in advanced wt BRAF
melanoma. PACMEL
A Phase II Study of Pazopanib in Metastatic Merkel
Cell Carcinoma
TRISST: Trial of imaging and schedule in seminoma
testis
Preop CPET testing and exercise training in colorectal
patients
62
APermissions
delayed/denie
d
Sponsor
Y
NHS Provider
Y
Neither
Y
Neither
14/05/2013
24/07/2013
No
24/10/2013
08/11/2013
Yes
18/11/2013
15
10
25
Yes
Please Select...
A randomised controlled trial of reinforcement of
closure of stoma site using a biological mesh
07/10/2013
08/10/2013
Yes
30/10/2013
1
22
23
Yes
Please Select...
12/LO/0940
Health-Related Quality of Life in two treatment
pathways for open angle glaucoma and ocular
hypertension: a randomised controlled trial of initial
selective laser trabeculoplasty versus conventional
medical therapy. ("LiGHT")
03/06/2013
11/06/2013
Yes
01/07/2013
8
20
28
Yes
Please Select...
12/WM/0001
A Randomised Controlled Trial of standard wound
management versus negative pressure wound therapy
14/06/2013
in the treatment of adult patients with an open fracture
of the lower limb
11/07/2013
Yes
01/10/2013
27
82
109
No
27750
13/EE/0023
A randomized, double-blind, placebo-controlled, phase
2 study to assess the efficacy, safety, and dose
response relationship of ASP1707 in subjects with
endometriosis associated pelvic pain for 12 weeks,
21/03/2013
followed by a 12-week double-blind extension without
placebo control, including a 24-week open label
leuprorelin acetate treatment group for Bone Mineral
Density assessment
28/03/2013
Yes
06/08/2013
7
131
138
No
Y
Neither
27751
13/EE/0060
18/04/2013
No
69
No
Y
Neither
27752
10/H1202/81
27/06/2013
No
92
No
Y
Neither
A behavioural lifestyle intervention for colorectal cancer
08/02/2013
survivors
Transanal Endoscopic Microsurgery (TEM) and
27/03/2013
Radiotherapy in Early Rectal Cancer
71
Y
Neither
Y
Neither
27753
12/YH/0422
Clinical survey of the new Ponto wide implant to
determine outcomes in terms of implant stability and
adverse reactions following the implantation of the
Ponto bone-anchored hearing system and the Ponto
wide implant.
30/01/2013
07/02/2013
Yes
22/03/2013
8
43
51
Yes
Please Select...
27754
12/EE/0522
Sentinel Node Biopsy using Magnetic Nanoparticles: A
prospective multicentre feasibility nonrandomised
10/06/2013
clinical trial to compare sentinel node biopsy using
magnetic nanoparticles vs. standard technique
18/06/2013
Yes
25/06/2013
8
7
15
Yes
Please Select...
27755
12/NE/0301
Spot protein creatinine ratio (SPCr) and spot albumin
creatinine ratio (SACr) in the assessment of preeclampsia: A diagnostic accuracy study with decision
analytic model based economic evaluation and
acceptability analysis (DAPPA)
25/11/2013
26/11/2013
Yes
17/12/2013
1
21
22
Yes
Please Select...
27756
12/EE/0529
25/04/2013
4
31
35
Yes
Please Select...
27757
11/NW/0782
27758
27759
09/H0703/101
11/WM/0287
27760
13/EE/0256
27761
13/YH/0111
Investigation of the Efficacy of Bioactive ? Tricalcium
Phosphate Bone Graft in Achieving Posterolateral
Lumbar Fusion in Degenerative Lumbar
Spondylolisthesis
A phase III randomised trial of Peri-Operative
chemotherapy versus sUrveillance in upper Tract
urothelial cancer
Insight H1N1v Outpatient Study [FLU 002]
DESKTOP III
The effects of study participation on patient adherence
behaviour
21/03/2013
25/03/2013
Yes
29/08/2013
11/09/2013
No
02/01/2013
08/03/2013
31/01/2013
26/03/2013
Yes
No
19/03/2013
29
18
47
76
No
No
25/09/2013
02/10/2013
Yes
15/10/2013
7
13
20
Yes
Please Select...
Efficacy and Safety of FIAsp compared to insulin
aspart in Combination with insulin glargine and
metformin in adultswith Type 2 Diabetes
12/08/2013
22/08/2013
Yes
02/10/2013
10
41
51
Yes
Please Select...
13
No
Y
Neither
Y
Neither
Neither
Y
Y
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