Transcript Document

DCRIN,
Copenhagen Trial Unit and
Danish clinical research
Christian Gluud,
DCRIN, National Coordinator
CTU, Head of Department
DCRIN - Danish Clinical Research
Infrastructures Network
Jens Sandahl Christiansen, Torben Lauersen, Aarhus University
Ove Andersen, The Research Unit, Hvidovre Hospital
Arne Astrup, Depart. Human Nutrition, Copenhagen University
Hans Jørn Kolmos, Per Damkier, and Kim Brøsen, Odense University
Gedske Daugaard, Department of Oncology, Rigshospitalet
Peter Gimsing, Depart. of Haematology, Rigshospitalet
Karin Friis-Back, The GCP Unit, Copenhagen University
Annette Jørgensen, The GCP Unit, Odense University
Charlotte Calov, The GCP Unit, Aarhus University
Jørn Wetterslev, and Christian Gluud
Copenhagen Trial Unit (CTU), Rigshospitalet, Copenhagen University
GCP units: Unique in Europe
• Established to comply with the EU
•
•
•
•
Directive
Planning
Monitoring
30 full time positions
2 million Euro
GCP units
• discussion of the trial protocol
• guidance in patient information
• case report forms
• notification of regulatory authorities
• initiation visits
• GCP monitoring
• adverse event reporting
• correct archiving
• closure visits
• standard operating procedures
Monitoring data in clinical trials
Source data
Case record forms
Data entry into computers
Data cleaning
Data analyses
Report plus publications
Data flow
- future need for monitorering
- the ’custom’ model
Source data
Publication
IN DEPT MONITORING OF TRIALS ACCORDING TO
•
RISK ASSESSMENT AND
•
RANDOM SELECTION
Copenhagen Trial Unit (CTU)
Centre for Clinical intervention Research
Objectives
• Conduct scientifically valid randomised trials
• Conduct scientifically valid systematic reviews
with meta-analyses of randomised trials
• Develop these two areas
• Educate postgraduatedly on these two areas
Copenhagen Trial Unit (CTU)
Centre for Clinical intervention Research
• Established 1995
• 15 clinical researchers and research
assistants
• Yearly budget 700,000 Euro
• A trial service unit, not a control
organisation
Copenhagen Trial Unit (CTU)
Centre for Clinical intervention Research
Conduct scientifically valid randomised trials
•
40 randomised clinical trials
•
psychiatry to foot warts
•
total of 15,000 randomised
Number of randomised participants in CTU trials
1995 to 2008
16000
14000
12000
10000
8000
6000
4000
2000
0
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
Participants
03
20
04
20
05
20
06
20
07
20
08
Copenhagen Trial Unit (CTU)
Conduct scientifically valid systematic reviews
with meta-analyses of randomised trials
• The Cochrane Hepato-Biliary Group since 1996
• More than 1400 members
• More than 330 registered titles
• More than 279 protocols
• More than 121 systematic reviews
• Fifth most productive Cochrane Review Group
Copenhagen Trial Unit (CTU)
Develop these two areas
• Randomisation systems
• Data management systems
• Trial sequential analyses
Copenhagen Trial Unit (CTU)
Educate postgraduatedly on these two areas
• Numerous train-the-trainer courses and
workshops
• Biannual CHBG meetings during
EASL/AASLD meetings
• Digestive Disease Week meetings
140000
Periodic growth of publications on randomised and
controlled clinical trials
131223
121584
120000
99373
100000
80000
67522
60000
45020
40000
26322
16155
20000
8823
75
498
1900 to
1946
1947 to
1951
979
1647
3118
1957 to
1961
1962 to
1966
0
1952 to
1956
1967 to
1971
1972 to
1976
1977 to
1981
Year period
1982 to
1986
1987 to
1991
1992 to
1996
1997 to
2001
2002 to
2007
1200
1127
1000
Number of publications on randomised and controlled
clinical trials
published per million inhabitants
1014
945
881
800
713
666
600
632
594
587
559
438
430
426
355
400
349
254
250
199
200
188
175
Gr
ee
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ly
ng
ap
or
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bia
(T
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rm
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y
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um
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lgi
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i
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lan
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ia
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ala
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th
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lan
ds
Sw
it z
er
lan
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d
ite
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Un
ate
ite
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d
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ng
do
m
No
rw
ay
Th
e
Ne
w
Sw
ed
en
Fi
nla
nd
De
nm
ar
k
0
Number of publications on randomised and controlled
clinical trials
per year from 2002 through 2007
14000
12371
12000
12138
11208
10702
10052
10000
8095
8018
8000
7249
7073
USA
7176
EU
Canada
6000
Rest of the world
4950
4723
4719
4330
3699
4000
4633
3516
2188
2000
697
683
694
712
647
354
0
2002
2003
2004
2005
2006
2007
Thank you !
Regulatory framework
Proposal
Authorised
D
M
A
R
E
C
D
W
E
A
D
N
F
A
D
D
P
A
Regulatory framework
Proposal
Authorised
CT on MP
CT using gene
therapy /GMOs
D
M
A
R
E
C
D
W
E
A
D
N
F
A
D
D
P
A
Regulatory framework
Proposal
Authorised
CT on MP
CT using gene
therapy /GMOs
CT using herbal,
vitamin, mineral
CT on MD
D
M
A
R
E
C
D
W
E
A
D
N
F
A
D
D
P
A
Regulatory framework
Proposal
Authorised
CT on MP
CT using gene
therapy /GMOs
CT using herbal,
vitamin, mineral
CT on MD
No MP (nutrition,
diagnistic, OTT, noninterventional)
No MP retro, obs,
non-interventional,
no bio samples
D
M
A
R
E
C
D
W
E
A
D
N
F
A
D
D
P
A