28th NOV, 2007
Abstract Submission Deadline Nurses Group.
Abstract Submission Deadline Physicians & Data Management Group.
Deadline for early registration (reduced fee) and Hotel reservation.
Notification for acceptance of abstracts.
Final Programme available on the Internet.
Deadline for intermediate registration fee.
2nd Patient & Family Day, Florence, Italy.
EBMT 2008 congress in progress, Florence, Italy.
Please for more information about a specific meeting refer to:
30th MAR–2nd APR, 2008
EBMT 2008
Prospective Clinical Trials Update
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Work continues on developing the infrastructure to support a Prospective Clinical Trials Programme within the EBMT. The latest major development has been the move of the London EBMT office from University College London Hospital to Guy’s Hospital. Sadly this ended the 17 year association of the EBMT and UCLH but was necessary as the open plan office policy adopted by UCLH could not provide the secure environment required for the conduct of Prospective Clinical Trials. However, we would like to thank UCLH for hosting the office for so long and in particular, Prof Tony Goldstone, for his support.
The Registry and Prospective Clinical Trials teams moved to a newly refurbished suite of offices on the 12th Floor of Guy’s Tower on the 17th September. The PCT team have sole use of a huge room, for the co-ordinators based in London, as well as two smaller offices for Kim Champion, Clinical Trials Operations Manager and Zoë Doran, Director, Clinical Trials Operations. Locked storage areas have also been provided along with a meeting room and kitchen which are shared with the Registry. Panoramic views of London add the icing on the cake but most importantly the EBMT now has offices that are conductive to running Prospective Clinical Trials and room to expand. We would like to thank Dr Majid Kazmi for his enthusiastic support of the EBMT and Guy’s Hospital for providing re-furbished office space for our use as well as a great welcome and support establishing us in our new home. A particular vote of thanks goes to Catherine French, Haematology Delivery Manager who has gone beyond the call of duty to help us.
On the staffing front, a new post of Senior Clinical Trials Co-ordinator/Training Supervisor was created earlier this year and Georgia Bullock took up this position in June. She will provide a much needed day-to-day link between the London and Leiden Offices and ensure that all members of staff receive appropriate training in adherence to ICH-CGP. Georgia’s position will facilitate optimisation of resources as she can delegate tasks from one office to another as dictated by work-load. Fortnightly PCT (Prospective Clinical Trial) meetings are now held via Skype which are attended by all members of the two offices and the EBMT monitor Sandra Schreck, based in Leipzig. These are improving communication and collaboration between the CT staff.
We continue to develop the support infrastructure on the administrative side of protocol development. The objective is to reduce the administrative burden on clinicians of finalising and submitting a protocol. CTO staff in both the London and Leiden Offices will now take on the responsibility for adding all administrative/ICH-GCP sections of the protocol. All CTA applications are now done in the London Office by Kim Champion, who also provides submission packs for the country leads. More recently we have experimented with doing the actual submissions, notable National Ethics and Competent Authority in the UK, and Competent Authority in Austria, Germany and Switzerland. This strategy has proved very successful, bringing approval time down to less than 3 months! It is the intention to expand the scope of this project with the eventual aim of doing all submissions within the CTOs.
Next steps? Staffing continues to be reviewed on an on-going basis, whilst the support of academic studies with no potential funding remains a major challenge. We continue to explore options and make every effort to find innovative solutions. Remote monitoring via statistics is a new concept for the PCT team, but one which may be very useful, ensuring we can meet our obligations as a sponsor in a very cost effective manner. Updated SOPs to reflect current practice as we develop a more robust infrastructure are being finalised. Next on the list - IT support and software to support registration level studies, investigation of the latter is well on the way. In summary, a work in progress, we have made great strides but the journey continues.
Zoë Doran
Director Clinical Trials Operations
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