Download Performance in Initiating Research, January 2015 Research Ethics

Performance in Initiating Research, January 2015
Research
Ethics
Committee
Reference
Number
Name of Trial
Date of
Receipt of
Valid
Research
Application
Date of NHS
Permission
First
Patient
Recruited?
12/SS/0138
RESTART or
STOP
Antithrombotics
Randomised
Trial:
RESTART
26/03/2014
22/04/2014
No
11/WM/0164
AntiEpileptic
drug Monitoring
in PREgnancy:
An evaluation of
effectiveness,
costeffectiveness and
acceptability of
dose monitoring
strategies:
EMPIRE
15/05/2014
20/05/2014
Yes
13/NE/0262
A Phase 3
randomised,
double-blind,
placebocontrolled, study
of the efficacy
and safety of 2
doses of
Tofacitinib (CP690,550) or
Adalimumab in
Subjects with
Active Psoriatic
Arthritis
21/05/2014
21/05/2014
No
Date of
First
Patient
Recruited
Duration
Between
VRA and
NHS
Permission
(days)
Duration
Between
NHS
Permission
and First
Patient
(days)
Duration
Between
VRA and
First
Patient
(days)
27
12/08/2014
5
0
84
89
Benchmark
Met
Reasons
for not
meeting
Benchmark
No
No eligible
patients
seen.
No
No patients
consented.
No
Sponsor
delayed
'Green
Light' date;
then no
eligible
patients
seen.
13/NW/0738
A pilot study to
assess whether
humidified
oxygen is more
effective than
standard oxygen
therapy in
treating children
with acute
severe asthma:
HUMOX
13/SC/0436
Early low dose
steroids for
adults admitted
to hospital with
influenza-like
illness during a
pandemic: a
randomised
placebo
controlled trial:
ASAP
13/LO/1115
13/NW/0184
UK Multicentre
Open label
Randomised
Controlled Trial
Of IV Iron
Therapy In
Incident
Haemodialysis
Patients:
PIVOTAL
The clinical and
costeffectiveness of
temporarily
quadrupling the
dose of inhaled
steroid to
prevent asthma
exacerbations; a
pragmatic,
randomised,
21/05/2014
22/05/2014
No
1
0
No
Sponsor
delayed
'Green
Light' date;
then no
eligible
patients
seen.
No
No patients
seen. We
can only
recruit to
study if
there is a flu
pandemic.
12/06/2014
12/06/2014
No
30/06/2014
02/07/2014
Yes
24/11/14
2
145
147
No
No eligible
patients
seen.
29/07/2014
04/08/2014
Yes
02/09/2014
6
29
35
Yes
N/A
Benchmark
met
normal care
controlled,
clinical trial
13/WA/1084
A NCRI AML
working group
pilot under the
auspices of the
Cardiff
experimental
cancer medicine
centre to
establish the
feasibility of
combining the
tyrosine kinase
inhibitor,
ponatinib with
chemotherapy in
patients with
AML with a flt3
mutation
29/07/2014
07/08/2014
No
9
No
No patients
seen.
13/NS/0115
A multicentre
RCT comparing
laparoscopic
supra-cervical
hysterectomy
with second
generation
ablation for the
treatment of
heavy menstrual
bleeding:
HEALTH
14/08/2014
20/08/2014
No
6
No
No patients
consented.
13/EM/0239
Remifentanil
intravenous
patient
controlled
analgesia (PCA)
versus
intramuscular
pethidine for
pain relief in
labour: a
No
Staff
availability
issues and
also no
patients
consented
20/08/2014
21/08/2014
No
1
randomised
controlled trial
14/NW/1234
Pulse on the
Finger – Is an
iphone app
accurate
enough to
measure heart
rates in adult
patients
presenting to
the emergency
department
compared to
radial pulse
palpation
13/NS/0143
SIMS Adjustable
Anchored
SingleIncision
MiniSlings
Versus
Standard
TensionFree
MidUrethral
Slings in the
Surgical
Management Of
Female Stress
Urinary
Incontinence; A
Pragmatic
Multicentre
Non–Inferiority
RCT
11/08/2014
09/10/2014
21/08/2014
10/12/2014
Yes
No
08/09/2014
10
18
28
Yes
N/A
Benchmark
met
No
Study
suspended
by Sponsor
- Sponsor
advised
currently
unable to
recruit and
randomised
any patients
at any site.
14/WM/1078
A Randomised
double-blind,
placebocontrolled phase
2 study to
assess the
immune
response
follownig
administration of
Zoster Vaccine
to subjects with
RA receiving
Tofacitinib (CP690,550) or
placebo with
background
methotrexate
treatment
26/11/2014
10/12/2014
No
No
Sponsor
delays Sponsor
delays in
supplying
IMP to site.