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Carrle 2009.11.06 The Eur opean and Am erican O steosarcoma S tudy EURAMOS-1 A successful transatlantic cooperation in Osteosarcoma D Carrle, S Bielack,

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Presentation on theme: "Carrle 2009.11.06 The Eur opean and Am erican O steosarcoma S tudy EURAMOS-1 A successful transatlantic cooperation in Osteosarcoma D Carrle, S Bielack,"— Presentation transcript:

1 Carrle 2009.11.06 The Eur opean and Am erican O steosarcoma S tudy EURAMOS-1 A successful transatlantic cooperation in Osteosarcoma D Carrle, S Bielack, M Sydes, T Butterfass-Bahloul, G Calaminus, G Jovic, N Marina, A Oellers M Perisoglou, S Smeland, J Whelan, M Bernstein Supported by the European Science Foundation under the EUROCORES Programme European Clinical Trials (ECT) Sixth Framework Programme, under Contract no: ERAS-CT-2003-980409 of the European Commission DG Research FP6

2 Carrle 2009.11.06 EURAMOS-1: Study objectives 2 Focuses:  Scientific: Improve treatment results: Poor responder: Salvage therapy (+/- HD-Ifo/Eto) Good reponder: Maintenance therapy (+/- Peg-Interferon)

3 Carrle 2009.11.06 EURAMOS-1: Study objectives 2 Focuses:  Scientific: Improve treatment results: Poor responder: Salvage therapy (+/- HD-Ifo/Eto) Good reponder: Maintenance therapy (+/- Peg-Interferon)  Feasibility of international collaborations

4 Carrle 2009.11.06 Disclaimer This presentation is not about survival data of EURAMOS-1 but about other relevant outcome from a large multinational clinical trial

5 Carrle 2009.11.06 Osteosarcoma: 5-Year Survival Osteosarcoma: Internat study results Stiller et al EJC 2006Mirabello et al Cancer 2009

6 Carrle 2009.11.06 Osteosarcoma: 5-Year Survival Survival plateau Osteosarcoma: Internat study results Stiller et al EJC 2006Mirabello et al Cancer 2009

7 Carrle 2009.11.06 Osteosarcoma: 5-Year Survival Survival plateau Slow Progress Osteosarcoma: Internat study results Stiller et al EJC 2006Mirabello et al Cancer 2009

8 Carrle 2009.11.06 Osteosarcoma: 5-Year Survival Survival plateau Slow Progress Salvage-question unresolved Osteosarcoma: Internat study results Stiller et al EJC 2006Mirabello et al Cancer 2009

9 Carrle 2009.11.06 Osteosarcoma: 5-Year Survival Survival plateau Slow Progress Salvage-question unresolved Osteosarcoma: Internat study results Stiller et al EJC 2006Mirabello et al Cancer 2009

10 Carrle 2009.11.06 Osteosarcoma: 5-Year Survival Survival plateau Slow Progress Salvage-question  700 poor responders  2000 patients Osteosarcoma: Internat study results Stiller et al EJC 2006Mirabello et al Cancer 2009

11 Carrle 2009.11.06 years Multiinst. Osteosarcoma Studygroups Study duration (years) for recruitment of 2000 patients COG COSS EOI SSG SFOP 166/y 80/y 53/y 52/y 33/y

12 Carrle 2009.11.06 Multiinst. Osteosarcoma Studygroups Study duration (years) for recruitment of 2000 patients COG COSS EOI SSG SFOP 166/y 80/y 53/y 52/y 33/y years

13 Carrle 2009.11.06 EURAMOS-countries : Potential recruitment 583 Mio = 8.7% of world population Osteosarkom-Inc. ≈2-3 per Mio/Year ≈50% eligible  730/year

14 Carrle 2009.11.06 Pro International collaboration EURAMOS Scientific rationale Rapid accrual –> quicker results + answers  Improve Cure Rate Hawkins D J Ped Hem 2004 Trimble et al JCO 2009

15 Carrle 2009.11.06 Pro International collaboration EURAMOS Scientific rationale Rapid accrual –> quicker results + answers  Improve Cure Rate Additional infrastruc- ture requirements Differing regulations Money  no uniform funding,  more costly Pragmatism Less glory per investi- gator Contra Trimble et al JCO 2009 Hawkins D J Ped Hem 2004

16 Carrle 2009.11.06 EURAMOS-group 1st. Meeting Brisbane 2001

17 Carrle 2009.11.06 EURAMOS-group 1st. Meeting Brisbane 2001 Research and Development Department

18 Carrle 2009.11.06 Research and Development Department Crazy Dreamer Division EURAMOS-group 1st. Meeting Brisbane 2001

19 Carrle 2009.11.06 SSG COG EOI COSS EURAMOS: Pan-European/American Collaboration 4 studygroups - 15 countries -

20 Carrle 2009.11.06 Office for Human Research Protections (OHRP) Federalwide Assurance (FWA) assurance of compliance with the federal regulations for the Protection of Human Subjects for International (Non-U.S.) Institutions Original demand one FWA from each non-U.S. trial center Problem >> 100 non-U.S. trial centers

21 Carrle 2009.11.06 Office for Human Research Protections (OHRP) Federalwide Assurance (FWA) assurance of compliance with the federal regulations for the Protection of Human Subjects for International (Non-U.S.) Institutions Original demand one FWA from each non-U.S. trial center Problem >> 100 non-U.S. trial centers Solution one FWA per coordinating center (study group)

22 Carrle 2009.11.06 EU-Directive 2001/20/EC Implementation of Good Clinical Practice Aim: hamonize + simplify legal requirements for human research

23 Carrle 2009.11.06 EU-Directive:Complexity Europe - Fragmentation EU-Directive ≠ Law  Implementation differs among member nations

24 Carrle 2009.11.06 EURAMOS in Europe: 12 countries 12 different national interpretations 12ethics committees but 1 sponsor EU-Directive:Complexity Europe - Fragmentation

25 Carrle 2009.11.06 Legal responsibility initiation, management and/or funding of the trial in countries with different jurisdiction Sponsor Euramos according to EU-Directive 2001/20 EC

26 Carrle 2009.11.06 Delegation of responsibilities Sponsor Euramos according to EU-Directive 2001/20 EC

27 Carrle 2009.11.06 Delegation of responsibilities Non-fault insurance Funding Ethics committes regulatory Sponsor Euramos according to EU-Directive 2001/20 EC

28 Carrle 2009.11.06 COSS COG EOISSG Common Infrastructure Dataflow

29 Carrle 2009.11.06 COSS COG EOISSG Common Infrastructure Dataflow

30 Carrle 2009.11.06 Münster Thanks to Matt Sydes - MRC 2008!

31 Carrle 2009.11.06 Lobbying Lancet Oncology 2007 OECD-workshop 10.Nov 09 Brussel Can we facilitate Investigator-driven Clinical Trials?

32 Carrle 2009.11.06 EURAMOS-CDC, MRC London Recruitment 1574 Patients from 312 Institutions in 15 Countries

33 Carrle 2009.11.06 EURAMOS-countries : recruitment Comparison: actual (3.5 years) - potential Potential recruite- ment  730/y

34 Carrle 2009.11.06 Recruitment by continent Northamerica+associates vs Europe

35 Carrle 2009.11.06 Country-specific recruitment 30.Sept 09 CentersPat.P/C 1477014.8 763244.3 25 2158.6 4 7117.8 14 614.4 6335.5 6305.0 CentersPat. P/C 8293.6 3279.0 6193.2 2199.5 2157.5 5122.5 382.7 133.0 -Phenomen: S Bielack

36 Carrle 2009.11.06 Recruitment by age: young adults MRC-CDC 30.09.09 0 500 1000 1500 Cumulative registrations Jul-05 Jul-06 Jul-07 Jul-08 Jul-09 Reg Date <19 years>20 years Cumulative registrations by age Eligibility: Age < 40yrs

37 Carrle 2009.11.06 EURAMOS-1 Recruitment by age *Mascarenhas et al 2006

38 Carrle 2009.11.06 Recruitment by age: study groups

39 Carrle 2009.11.06 Conclusion EURAMOS-1 successful international collaboration  Functioning infrastructure established  Considerable bureaucratic obstacles overcome Excellent recruitment+time-scale  Largest OS trial ever Future: to continue collaboration

40 Carrle 2009.11.06 Acknowledgement: EURAMOS-1 Joint effort:Crazy Dreamer Division +Research and Development Dpt

41 Carrle 2009.11.06 EURAMOS-1 EURAMOS-Investigator Meeting London 2008 Joint effort:Crazy Dreamer Division +Research and Development Dpt

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