EBMT investigates the challenges of conducting academic clinical trials as part of the CLINT Clinical Trials Grant - PRESS RELEASE -
EBMT Annual Congress, Florence, Italy – 2 April 2008 – A highlight of the EBMT Annual Congress today was a session on the CLINT Clinical Trials programme. The session was organized to determine the benefits as well as the obstacles and policy issues of obtaining true pan-European clinical trials as part of the CLINT funding programme of the EU’s Sixth Framework.
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, presented by the Centre of Professional Ethics from the University of Central Lancashire and conducted 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. To this end, EBMT is funded, along with other partners, under the EU Sixth Framework Programme to carry out the project.
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.”
By the end of the study, EBMT will identify problems, develop methodologies, and make policy recommendations to facilitate the measures required to conduct academic trans-European clinical trials in stem-cell transplantation.
The EBMT 34th Annual Congress concluded today, wrapping up a successful five day conference, with a record number of participants and patients visiting the Congress.
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About the European Group for Blood and Marrow Transplantation
Bone marrow or stem cell transplantation is often the only curative treatment for different malignant diseases and is currently performed on more that 50,000 patients worldwide each year. The European Group for Blood and Marrow Transplantation (EBMT) as the leading non-profit, scientific society representing 530 transplant centres in and outside Europe, promotes all activity aiming to improve stem cell transplantation or cellular therapy. This includes registering all the activity relating to stem cell transplants with a view to improving treatment outcomes for patients. EBMT has set standards for indication and treatment for malignant and non-malignant diseases, along with running training programmes for continual professional development. These are continually audited and updated. EBMT is also responsible for accrediting the transplant centres based on their performance and data reporting. For more information, please visit www.ebmt.org
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