Dear Colleagues,

We have received a questionnaire from an EU funded project, ICREL, that is charged with collecting information on the impact of the EU Clinical trials directive on the activities of organisations that sponsor or host the principal investigators of non-commercial trials. All of the clinical trial groups and national childhood organisations working with SIOP Europe fall into this category. We are therefore circulating the questionnaire to all of the groups on our database and urge you to complete it and submit a response by the requested deadline of mid July 2008. We believe that the responses to this questionnaire will be influential in providing a true measure of the impact on clinical trial activity since May 2004. The coordinating body, ICREL, has the full support of the key players in this area in Europe and is funded by the FP7 to produce metrics that can be used for the commission to decide on whether a full review of the Clinical trials directive is merited.  

They are requesting metrics from sponsors of non-commercial trials only, comparing activities and timelines in two periods: 2003 and 2007.

The information requested is quite detailed (numbers of trials opened, types of trials, numbers of patients recruited, timelines for opening and for processing amendments etc). However, I hope that many of you have already collated at least some of this information for other purposes and may have some of it already to hand. Also, the ICREL survey does allow approximate numbers where accurate figures would take too much time to calculate.

Please could I urge your trial group or national childhood organisation to submit a response to this important questionnaire, so that the impact on availability of clinical trials to childhood cancer patients is fully documented. 

Please could you ensure your submit your response before the deadline of July 20th 2008.  Please could you copy in the SIOPE secretariat to your reply.

It seems that things may be happening for the better. Your input is vital to keep the voice of children with cancer in Europe heard at the highest political levels. 

Many thanks and I look forward to meeting with you all again during the SIOP conference in Berlin (Friday October 3rd, lunchtime).

Regards

Kathy Pritchard-Jones

SIOPE President