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A European Perspective

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

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A European Perspective

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  1. A European Perspective Dr Bruce Morland Chairman United Kingdom Children’s Cancer Study Group (UKCCSG) New Agents Committee

  2. Challenges • Access to new drugs alongsidenotafter 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

  3. United Kingdom Children’s Cancer Study Group

  4. UKCCSG • Founded in 1977 • 22 treatment centres in UK • 380 members • 40 overseas members • UKCCSG Data Centre in Leicester

  5. New Agents Group • Formed in 1987 • Involved in Phase I/II trials • Relapse Registry • 1995 established formal link and collaboration with SFOP pharmacology group

  6. 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

  7. 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

  8. 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

  9. Opening a study • 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.

  10. UKCCSG Code of ConductPhase I studies • Commitments • Documentation • GCP • SAE’s (24hrs) • Monitoring • Staffing • Lead clinician • Research Nurse • Pharmacist • Facilities • Drug supply • PK studies • Data storage

  11. UKCCSG Code of ConductPhase II studies • Commitments • SAE reporting (not necessarily 24hr) • Staffing • Data manager or research nurse

  12. The NAG/SFOP collaboration

  13. Joint studies • Phase II Temozolomide • PSC833 Phase I • DaunoXome Phase I • CPT11 Phase II

  14. Preclinical Studies Xenografts Phase I Phase II Development of CPT-11 in Paediatric Oncology in Europe 1990 1992 1994 1996 1998 2000 2002 ADULTS Phase I F E Approval Phase II Children The facts 7 years The goal 18 months

  15. European New Drug Developmentrecent 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 drugsall started after approval for adults *NAG and GP-SFOP

  16. TheITCC Project • An Integrated Pan European Clinical Research Networkto design and conducta comprehensive drug development programme in pediatric cancers

  17. TheITCC Project • Core Group • IGR • CR-UK • NAG – UKCCSG • GP-SFOP • NL-NAG • Westfalische Wilhelms Universitat, Münster • PG- AIEOP • University of Newcasttle

  18. Academia Pharma CRUK ITCC UKCCSG SFOP etc. Regulatory Authorities Treating institutions

  19. Preclinical Studies Xenografts Phase I Phase II Development of CPT-11 in Paediatric Oncology in Europe 1990 1992 1994 1996 1998 2000 2002 ADULTS Phase I F E Approval Phase II Children The facts 7 years The goal 18 months

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