• Last Minute Preparations for
  EBMT 2008

• CLINT Meetings
• Nuclear Accident Committee Session
• Statistical Symposium
• Developmental Committee Meeting

JACIE Session

Quality Management Exploratory Meeting

NPG: How to Get Published session

Statistical Roundtable Debate
Tuesday, 1st April 2008
16:00-18:00
Hall M

We are pleased to invite internationally renowned biostatisticians Professor Jason P Fine (University of North Carolina) and Dr. Jan Beyersmann (Institute of Medical Biometry and Medical Informatics, Freiburg) to participate in an innovative roundtable discussion at EBMT 2008. Richard Zydlo will chair what promises to be a very interesting debate.

The primary aim of this session is to initiate a debate on current issues in the statistical analysis of stem cell transplant data, including competing risks analysis and centre effect in multi-centre trials. It is part of a broader endeavour to derive international consensus on the methodology underpinning statistical analysis in the field.

This session is organised by M. Labopin and A. Latouche as part of the EU project 'Facilitating International Prospective Clinical Trials in Stem Cell Transplantation' (CLINT) funded by the EC's Sixth Framework Programme.

M. Labopin
Chair of the Statistical Committee

Workshop on governance of Clinical Trials in Europe: An EBMT Perspective
Wednesday, 2nd April 2008
12:15 - 14:30
Hall M

This workshop will address the impact that the EU Clinical Trials Directive (Directive 2001/20/EC) has had on the conduct of clinical trials across Europe. Short presentations from the legal, ethical and trial administrative perspectives will be followed by discussions in breakout groups to debate the various issues and feedback to the group as a whole. This workshop will also present the initial findings of a pan-European review of research governance conducted by the Centre for Professional Ethics (University of Central Lancashire) on behalf of the EBMT as part of the EU project Facilitating International Prospective Clinical Trials in Stem Cell Transplantation (CLINT) funded by the EC's Sixth Framework Programme.

The workshop will:

• 	Present the problems of conducting pan-European academic prospective clinical trials following implementation of the Directive
  	Explore the elements of the Governance Framework that regulate, facilitate or restrict the successful completion of projects
  	Discuss the experiences of EBMT members and suggest good practices for future collaborative research and policy recommendations for regulators

  
  

The EBMT would like to use this workshop to help identify the obstacles and policy issues that are preventing prospective pan-European clinical trials. By so doing we hope to devise strategies to overcome these problems so that we can continue our long-standing and highly productive collaborations.

Jane Apperley
Co-ordinator of the CLINT Project

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Nuclear Accident Session
Tuesday 1st April 2008
13:30 - 15:30
Hall F

The Nuclear Accident Committee would welcome your attendance at their Educational Session. Expertly chaired by Prof Ray Powles and Prof Ted Fliedner, this session will be of great interest to clinicians and nurses and will allow them to see data first-hand on patients who have previously received stem cell transplantation for radiation accidents.

There will be an opportunity to debate on the timing of stem cell transplantation after radiation exposure, whether or not such patients should indeed undergo transplantation and if so, which patients should be transplanted? The use of mesenchymal stem cells in treating radiation accident victims also looks promising and will be discussed.

There will be an informative section looking at patients that may be pancytopenic following a major radiation accident/disaster, where it may not be possible to have the lymphocytes for HLA typing necessitating the use of HLA typing using buccal swabs and other novel methods.

Ray Powles
Chair of the Nuclear Accident Committee

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Statistical Symposium
Tuesday 1st April 2008
13:30 - 15:30 Hall M

The Statistical Committee warmly invites you to attend the Statistical Symposium at EBMT 2008. This symposium will be composed of four complementary talks targeted towards a wide audience. The following topics will be presented and discussed:

• Design and analysis of EORTC clinical trials: theory and practice
• Statistical planning of clinical trials: an emphasis on sample size determination
• Analysing competing risks data from transplantation studies
• Multi-state models: focus on S-plus/R packages

It is hoped that this informative session will incorporate a high level of clinical knowledge through the participation of lead Working Party members in the discussions, whilst at the same time providing an overview of what biostatisticians believe to be the mainstream methods to be applied to statistical analysis in our field.

Please make a reservation in your agenda for Tuesday 13.30 – 15.30 and we ask you to encourage all colleagues (clinicians, data managers and statisticians) with an interest in the methodology underlying the analysis of HSCT data to join the symposium.

Myriam Labopin
Ronald Brand
on behalf of the Statistical Committee

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Developmental Committee Meeting
Sunday 30th March 2008

14.00 – 17.00

Hall K, Cavedio Area

This business meeting will address: clinical trials using novel cell therapies, issues related to the clinical MSC Expansion Consortium, and implementation of the EBMT Cell Therapy Registry.

We will discuss completed, ongoing and future multi-centre trials using MSC to enhance haematopoietic cell engraftment, as immuno-modulators and in tissue healing. We will also discuss issues related to clinical grade expansion of mesenchymal stem cells, the fetal calf serum batch for the phase III studies, SOPs and common guidelines for viral testing and cytogenetics.

The Med A form of the Cell Therapy Registry (CTR) was implemented in the Promise database in July 2007. The aim of the meeting is to promote academic collaborative clinical trials in Europe evaluating the role of different novel cell therapies. Reporting and guidelines will be discussed, as well as the development of disease specific forms to include haematopoietic stem cell transplantation, rheumatologic, neurological and cardiology disorders etc.

Katarina Le Blanc and Wim Fibbe
Co-Chairs of the Developmental Committee

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JACIE Session
Monday 31st March 2008
12:30-13:30
Hall H

The JACIE Session at EBMT 2008 entitled 'Clinical Dilemmas in JACIE Accreditation' will place the emphasis on interaction with the audience in the form of panel discussions and Question-&-Answers. This is an ideal opportunity to raise issues or ask questions to the experts.

Eoin Mc Grath
JACIE Executive Officer

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Quality Management Exploratory Meeting
Monday 31st March 2008
10:30-12:30
Hall H

The primary aim of this exploratory meeting is to have an open discussion on how the profile of quality management can be raised at the EBMT annual meeting. A secondary aim is to establish a working group that will develop a programme to be included in the EBMT 2009 congress in Göteborg, Sweden.

Anyone with an interest in quality management is welcome to attend, and we would particularly encourage participation by quality managers, including ‘unofficial’ quality managers appointed to oversee the implementation of JACIE accreditation at their centre.

Eoin James Mac Hale
JACIE Administrator

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NPG: How to Get Published session

Tuesday 1st April 2008
12:30-13:30
Hall H

Professor John Goldman (Bone Marrow Transplantation, Editor-in-Chief) and Haroon Ashraf (Nature Publishing Group, Executive Editor) will explain how authors need to prepare their manuscripts for submissions to a peer reviewed journal. The process that a paper undergoes from submission to publication at Nature Publishing Group's Bone Marrow Transplantation will also be discussed.

Haroon Ashraf
NPG Executive Editor

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