PILOT STUDIES Brighton, 15 th February 2006 Public Health Program EUROPEAN COMMISSION: HEALTH & CONSUMER PROTECTION DIRECTORATE - GENERAL

COMMENTS TO PROTOCOL 1.The Task force on Treatment Pilot Studies has decided to go for a feasibility study on a Pilot study. 2.Poland, Portugal, Slovenja, Finland, Spain, Uk, France and Ireland are the countries that shall participate in this study, we await their formal confirmation and approval of the protocol by the National Group of each one of the EUROCHIP National Groups in one month from when we send it by it was decided that the core elements of the protocol should be checked in consultation with EUROPEAN CLINICAL ASSOCIATIONS who use the indicators everyday and are able to assess the robustness of each headline. This should be done by the Working Team of Eurochip but also locally with the informal contact that the National Groups can establish. 4.The template of the Feasibility study will include information on four dates plus other general info

COMMENTS TO PROTOCOL 5.the EUROCHIP Methodological Group will be working on a method to give the maximum power to the study ( number of cases, budget subdivision,number of registries involved in each country- a different criteria must be applied for those countries where the work will be done by the National Registry and those countries where 4 registries shall be involved) 6.from the national groups we still need a name for the researcher who will be involved in the data collection. 7.EUROCHIP should publish a pamphlet with the cover of the EUROPEAN COMMISSION DG- SANCO graphics so that this pamphlet with the results of EUROCHIP 1 is circulated and more officially recognised. 8.EUROCHIP should have a publication policy. 9.We hope that the study will start in one month, the collection of data to finish in one year, and the closure of data to be set in December 2007.