Transcript A European Perspective Dr Bruce Morland Chairman United Kingdom Children’s Cancer Study Group

A European Perspective
Dr Bruce Morland
Chairman United Kingdom
Children’s Cancer Study Group
(UKCCSG)
New Agents Committee
Challenges
• Access to new drugs alongside not after adult
Phase I/II development
• New European Legislation “Better Medicines for
Children” expected 2004
• Good Clinical Practice (GCP), Good
Manufacturing Practice (GMP), Doctors and
Dentists Exemption (DDX) - and likely impact on
academic drug development programmes
United Kingdom Children’s
Cancer Study Group
UKCCSG
•
•
•
•
•
Founded in 1977
22 treatment centres in UK
380 members
40 overseas members
UKCCSG Data Centre in Leicester
New Agents Group
•
•
•
•
Formed in 1987
Involved in Phase I/II trials
Relapse Registry
1995 established formal link and
collaboration with SFOP pharmacology
group
NAG Studies (1)
• NAG 8702
– Phase II carboplatin
• NAG 8801
– mIBG Phase I/II
• NAG 8802
– Etoposide Phase II in relapsed Wilms’ tumours
• NAG 9007
– GM-CSF prophylaxis post intensive chemo
• NAG 9009
– Monoclonal Targeting NHL/ALL
• NAG 9010
– Monoclonal targeting of medulloblastoma/PNET
NAG Studies (2)
• NAG 9012
– Phase I Thiotepa
• NAG 9203
– Oral etoposide Phase II
• NAG 9401
– Phase I Temozolomide
• NAG 9402
– Carboplatin pharmacokinetics
• NAG 9504
– Phase II Thiotepa
• NAG 9509
– Phase I AG337
• NAG 2000 01
– Phase I BU12-SAPORIN immunotoxin
UKCCSG Code of Conduct for
Clinical Trials
•
•
•
•
•
•
•
•
Finalised June 2000
Trial development
Opening a trial
During the course of a trial
Closure of a trial
Publication
Centre responsibilities
UKCCSG information/staff training
Opening a study
1.
2.
3.
4.
5.
6.
Initial discussions in NAG
Concept protocol to UKCCSG meeting
(Final protocol to UKCCSG meeting)
MREC submission
LREC submission
Open study
First thought to open study never less than 1 year
often 2 years.
UKCCSG Code of Conduct
Phase I studies
• Commitments
•
•
•
•
Documentation
GCP
SAE’s (24hrs)
Monitoring
• Staffing
• Lead clinician
• Research Nurse
• Pharmacist
• Facilities
• Drug supply
• PK studies
• Data storage
UKCCSG Code of Conduct
Phase II studies
• Commitments
• SAE reporting (not necessarily 24hr)
• Staffing
• Data manager or research nurse
The NAG/SFOP collaboration
Joint studies
•
•
•
•
Phase II Temozolomide
PSC833 Phase I
DaunoXome Phase I
CPT11 Phase II
Development of CPT-11 in Paediatric Oncology in
Europe
1990
1992
1994
1996
1998
2000
2002
ADULTS
Phase I
Phase II
F E Approval
Preclinical
Children
Xenografts
Studies
The facts
The goal
Phase I
Phase II
7 years
18 months
European New Drug
Development
recent achievements*
• Since 1995 :
8 phase I, 6 phase II, 1 PK (completed)
4 phase I, 2 phase II, 7 PK (ongoing or ready)
>500 patients
• 11 new drugs
all started after approval for adults
*NAG and GP-SFOP
The
ITCC Project
• An Integrated Pan European
Clinical Research Network
to design and conduct
a comprehensive drug development
programme in pediatric cancers
The
ITCC Project
• Core Group
–
–
–
–
–
–
IGR
CR-UK
NAG – UKCCSG
GP-SFOP
NL-NAG
Westfalische Wilhelms
Universitat, Münster
– PG- AIEOP
– University of Newcasttle
Academia
Pharma
CRUK
ITCC
Regulatory
Authorities
UKCCSG
SFOP etc.
Treating
institutions
Development of CPT-11 in Paediatric Oncology in
Europe
1990
1992
1994
1996
1998
2000
2002
ADULTS
Phase I
Phase II
F E Approval
Preclinical
Children
Xenografts
Studies
The facts
The goal
Phase I
Phase II
7 years
18 months