2. 1.10.03 - gvdCT Monitoring1 Swiss Agency for Therapeutic Products

3. 1.10.03 - gvdCT Monitoring2 Study Notification Activity ( 1996 - 2003 ) Review of the Clinical Trials activity in Switzerland G. Vital-Durand

4. 1.10.03 - gvdCT Monitoring3 Role of Swissmedic [ 1 ] Swiss Federal Regulatory Agency Established 2002 [ www.swissmedic.ch ]

5. 1.10.03 - gvdCT Monitoring4 Role of Swissmedic [ 2 ] NDA Reviews Marketing Authorisations Pharmacopoeia Monographies Pharmacovigilance [ Benini F. Bittere Medizin für Heilmittelinstitut. NZZ 2003 : 20th July ]

6. 1.10.03 - gvdCT Monitoring5 Role of Swissmedic [ 3 ]

7. 1.10.03 - gvdCT Monitoring6 Role of GCP Unit CT Notification and Follow-up Safety Data Collection GCP Monitoring [ Anonymous. Reglement über die Heilmittel im klinischen Versuch. Ergänzende Erläuterungen. Monatsbericht der IKS 2000 ; 3 : 158-62 ]

8. 1.10.03 - gvdCT Monitoring7 CT Flow Rate ( 1996 - 2003 )

9. 1.10.03 - gvdCT Monitoring8 CT Categorisation ( 1997 - 2002 )

10. 1.10.03 - gvdCT Monitoring9 Development Phases ( 1996 - 2002 )

11. 1.10.03 - gvdCT Monitoring10 Therapeutic Areas ( 1998 - 2002 )

12. 1.10.03 - gvdCT Monitoring11 Conclusions [ 1 ] Clinical Research is intensive, albeit on a slightly declining trend (to be reversed in 2003 ?) Most CT components have remained stable over time, e.g. flow, clinical phase distribution, multi- vs. monocentre type, distribution of therapeutic areas

13. 1.10.03 - gvdCT Monitoring12 Conclusions [ 2 ] The major 6 medical indications accounted for ca. one half (43-60 %) of the total CT activity, with minimal variations from year to year Phase-I CTs have been mostly conducted by CROs located in BL and TI, on assignment by foreign companies

14. 1.10.03 - gvdCT Monitoring13 Swiss Agency for Therapeutic Products