1st Workshop 2008: International Investigator-initiated Trials

The first workshop on international IITs was initiated and organised by the ELIC (European Leukemia Information Center) in Heidelberg at 31th January 2008. The major focus was on a practical and pragmatical approach to plan, initiate and conduct IITs within the Leukemia Net (ELN).

The workshop attracted about 100 persons from about 20 different countries. As a first result, the herewith provided website was established. It will serve as a platform for the ELN-members, involved in the acitvation process of international IITs.

Content

Agenda

The workshop considered experience from other international European working groups as ECRIN (European Clinical Research Infrastructure Network), EORTC (European Organisation on Research and Treatment of Cancer), EBMT (European Group for Blood and Marrow Transplantation) and KPOH (Competence Network on Pediatric Oncology and Hematology).

Part 1: General Overview
Chair: N. Gökbuget, J. Apperley

  • 1: Introduction, N. Gökbuget (ELN)
  • 2: How can ECRIN support investigators for the initiation and conduct of international academic trials, C. Kubiak (ECRIN)
  • 3: EORTC experiecne in activating international clinical trials (C. Lambert, EORTC)
  • 4: Successful initiation of international pediatric trials, C. Mauz-Körholz (KPOH)
  • 5: Promoting pan-European prospective clinical trials: The EBMT perspecitve, J. Apperley (EBMT)

Part 2: Experience and problems with international trials in the ELN: Short reports from WPs
Chair: E. Hellström-Lindberg, B. Simonsson

  • 6: CML: European collaboration in clinical trials for CML, B. Simonsson (WP4)
  • 7: AML: Expansion of the AML Intergroup Networking Study to further European trial groups, T. Büchner (WP5)
  • 8: ALL: Initiation of an international trial with Dasatinib for Ph+ALL, P. Rousselot (WP6)
  • 9: CLL: International trials of the GCLLSG: Regulatory requirements and correcitve actions, A. Westermann (WP7)
  • 10: MDS: Lenalidomide in high-risk MDS and AML with del5q or monosomi 5, E. Hellström-Lindberg (WP8)
  • 11: CMPD: From ECLAP to ELN clinical trials, T. Barbui (WP9)
  • 12: SCT: Conducting academic trials under EU-law, the EBMT experience, Z. Doran (EBMT)
  • 13: Registries: An alternative for clinical trials, J. Hasford (WP17)
  • 14: ELIC: Internet support for ELN trials, K. Ihrig (WP2)

Presentations

1st Workshop: Presentation pdf-slides

application/pdf 1_Introduction (47KB)
N. Gökbuget, ELN
application/pdf 2_ECRIN support for international IITs (185KB)
C. Kubiak, ECRIN
application/pdf 3_EORTC experience (56KB)
Lambert, EORTC
application/pdf 4_Successful initiation of international pediatric IIT (327KB)
Mauz-Körholz, KPOH
application/pdf 7_Expansion of AML (340KB)
Büchner, AML
application/pdf 8_International IIT with Dasatinib (68KB)
Rousselot, ALL
application/pdf 9_International trials of the GCLLSG (128KB)
Westermann, CLL
application/pdf 10_Lenalidomide in high-risk MDS and AML (34KB)
Hellström-Lindberg, MDS
application/pdf 11_From ECLAP to ELN (111KB)
Barbui, CMPD
application/pdf 12_Conducting academic trials under EU-law: The EBMT experience (417KB)
Doran, EBMT
application/pdf 13_Registries (81KB)
Hasford, WP17
application/pdf 14_ELIC internet support (24KB)
Ihrig, ELIC

Questionnary

To evaluate the general interest in the topic of "International IITs" and the content of the workshop, a short questionnary was prepared and offered to the attendees after the workshop. ELIC already received feedback directly after the workshop, but wants to give you all the opportunity to post your comments. This will takes only 1 min, as we cut the form down to only few items. Please fax the form back to ELIC. Thank you very much for your contribution and your interest!

Evaluation form

application/pdf Evaluation Form (26KB)
1st Workshop evaluation form