Addendum 1

SIOPEL publication and presentation guidelines 22.01.2008

Publication policy

•All SIOPEL trials will be published, irrespective of the results.

•Publication should be done in a timely fashion, as soon as the major endpoint(s) of the trial are fully evaluable

•The editorial plan of the SIOPEL group and the person/s in charge of each manuscript are defined and identified collectively by the SIOPEL Strategy Group based on the project responsibilities. It will be then responsibility of the SIOPEL Publication Committee to bring forward the editorial plan.

•It is the privilege and duty of the International Study Chair to prepare the manuscript. If this/these person/s is/are not able to produce a manuscript in reasonable time, the SIOPEL Publication Committee may appoint someone else.

•All quantitative evaluations must be carried out by the trial statistician under the supervision of the group statistician, unless decided otherwise by the SIOPEL committee.

•An appointed member of the SIOPEL Publication Committee will monitor progress of all Group publications

•All publications must be submitted electronically to the SIOPEL Publication Committee for approval, which will give its feedback within 15 working days.

•All abstracts must be submitted electronically to the SIOPEL Manuscript Committee for approval, which will give its feedback within 5 working days.

•Failure to request SIOPEL Publication Committee approval may result in a request that the paper or abstract is withdrawn.

•The major responsibility of the SIOPEL Publication Committee is to ensure scientific correctness and appropriate authorship. It is not the job of the SIOPEL Publication Committee to correct the language of the manuscript, which is expected to have been checked beforehand.

•The SIOPEL Publication Committee will report regularly its activity at the annual SIOPEL Committee meeting

Major Publications

•Major publications have as their purpose the first publication of results from the trial  (main endpoints). Sub-study publications (see below) include all other publications using SIOPEL patient data.

•All major publications must be published in the name of SIOPEL. Authorship should reflect major collaboration in any part of the trial. Inclusion of patients alone does not fulfill this criterion. Every modality needs to be represented by at least one author.

Example: Risk adapted treatment of childhood hepatoblastoma.

G. Perilongo, J. Zsiros, P. Brock, G. MacKinley, R. Maibach, M. Childs, J.

Plaschkes, for the International Childhood Liver Tumor Strategy Group (SIOPEL)

•All contributing investigators must be identified in an appendix, by country, together with their institution. The list is ordered alphabetically by country and centre.

•Support by CCLG, CRUK or other organisations and grant providers must be duly acknowledged.

•No centre or country may publish its own results from a trial prior to the Group's major publication.

Sub-study publications

•Sub-study publications include all non-major publications using SIOPEL patient data.

•Sub-study publications should be authored by specific individuals directly   responsible for the particular publication, in the name of SIOPEL.

Example:

Late cardiac effects after anthracyclines treatment of childhood hepatoblastoma.

G. Levitt, P. Brock, R. Maibach, M. Childs, J. Brown, for the International

Childhood Liver Tumor Strategy Group (SIOPEL)

•Sub-study publications should not precede the relevant major publication, unless this is agreed by the SIOPEL Publication Committee.

•Sub-study publications preceding a major publication should not include data on major endpoints' results, unless this is agreed by the SIOPEL Publication Committee.

•Data sent to individuals or other groups for analysis outside CCLG or IBCSG should follow all of the points above relating to sub-study publications.

Presentations

•Abstracts must be submitted in the name of the Group and be authored by the specific individuals directly responsible for the abstract preparation. In addition other key people (statistician, pathologist, trial coordinator etc.) should be coauthors.

Example:

Encouraging results of intensified preoperative treatment for high risk childhood

hepatoblastoma.

J. Zsiros, L. Brugières, P Czauderna, R. Maibach, M. Childs, G. Perilongo, for the

International Childhood Liver Tumor Strategy Group (SIOPEL)

•Data presented should not include major endpoint results from randomised ongoing trials, unless agreed by the SIOPEL Publication Committee.