CLINT Project Sessions at EBMT 2008

The EBMT 2008 meeting in Florence marked the end of the first year of the 2-year CLINT project funded by the EU under the Sixth Framework Programme. It was an ideal opportunity to bring together members of the CLINT Steering Committee for a project status review and to organise two sessions on key project activities: one was a debate involving statisticians and clinicians on the statistical and methodological approaches to SCT analyses, and the other a workshop to explore governance issues in relation to the management of trans-national clinical trials in SCT.

CLINT Statistical Roundtable Debate

Following the Statistical Symposium held at EBMT 2008, Jason P Fine (University of North Carolina) and Jan Beyersmann (Institute of Medical Biometry and Medical Informatics, Freiburg) led an innovative roundtable debate chaired by Richard Zydlo. The primary aim of this session was to initiate a debate between statisticians and physicians 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. It was concluded that this was an important forum for developing ideas and it was agree to organise a follow-up debate at EBMT 2009 in Göteborg. Minutes from the Roundtable Debate can be downloaded by clicking here.

This session was organised by Myriam Labopin and Aurelien Latouche under Work Package 5 of the CLINT project.

CLINT Project Workshop: Identifying and addressing legal and regulatory obstacles to European trans-national SCT research

This workshop session was organized to determine the benefits as well as the obstacles and policy issues of obtaining true pan-European clinical trials.

David Coles from the Centre for Professional Ethics, University of Central Lancashire, presenting the initial findings of a pan-European review of research governance conducted amongst EBMT members

Jane Apperley gives a clinician’s perspective on the questionnaire results

The workshop focused on two main aspects: the impact that the EU Clinical Trials Directive (2001/20/EC) has had on conducting clinical trials across Europe; as well as the presentation of a pan-European review into research governance conducted by the Centre of Professional Ethics from the University of Central Lancashire on behalf of EBMT.

The EU directive set out standards to improve the conduct of clinical trials. Its primary aim was not only to protect patients and improve standards but also to encourage competition and harmonize administrative procedures. Essentially, this directive imposed the same standards as for pharmaceutical trials, which has dramatically limited the flow of academic clinical trials.

Zoë Doran, Director of the Clinical Trials Operations EBMT commented “It is only possible to harmonize legislation through a Regulation. A Directive is open for local interpretations which leads to different requirements. Consequently, the Directive resulted in a complex administrative web and greatly increased expenses for academic research.”

As a result of the challenges observed in the implementation of this Directive, EBMT participated in an EU call with the intention of launching a project on Facilitating International Prospective Clinical Trials in Stem Cell Transplantation (CLINT). The objective of the project is to find ways to facilitate academic prospective clinical trials, establish best practice, and to develop policy recommendations for the ongoing implementation of the Directive and its Guidelines.

Besides the implementation issues, the Directive has generated ethical and logistical challenges. Dr. David Coles, who presented at the workshop, said, “preliminary data gathered shows that the time needed for approvals by the ethics committee and competent authority has increased since the implementation of the Directive.”

A shorter, more focused follow-up survey will be sent to EBMT investigators and national study groups to collect additional data. By the end of the study, EBMT will identify key problems, develop methodologies, and make policy recommendations to facilitate the measures required to conduct academic trans-European clinical trials in stem-cell transplantation.

(Click here to download slides)