Clinical Trial Network

Substudies

After publication of the pooled results, centres will be allowed to use their own anonymised data for local presentation and publication. Duplicate data publication is not permitted.

The anonymised pooled dataset may be available for secondary analyses upon specific request in form of a detailed study proposal (including authorship rules) to the Steering Committee. The final approval of these potential secondary analyses rests with the SC. Prior to journal submission, any paper originating from the pooled data will be reviewed by the SC that is also entitled to require revisions. Authorship of any publication derived from the pooled data set will include the group name “MET-REPAIR Investigators” with a byline clearly stating that the individual names are elsewhere in the paper and specifying whose individual names refer to authors and to collaborators, respectively. For transparency, the original paper has to be referenced to in all articles of secondary analyses.

Local or national nested cohorts addressing additional questions, i.e. question not addressed in MET-REPAIR and its substudy, and collecting additional data while sharing part of the variables collected for MET-REPAIR, are allowed under the following conditions: nomination of a separate sponsor (i.e., other than the ESA), separate ethical approval, separate informed consent, independent data management, and approval of a detailed study proposal by the SC. The Sponsor and the SC have the right to veto the nesting of a study into MET-REPAIR. The publication of any study nested within MET-REPAIR will occur after publication of the main results of MET-REPAIR (main objectives 1 and 2). For transparency, the original paper should be referenced to in all articles of nested analyses. Authorship rules for potential publications derived from such nested cohort studies are to be submitted to the Sponsor and SC together with the study proposal.

Requests for data sharing for sub-studies are to be addressed to the ESA and Steering Committee using the Substudies Request Form.

The following studies are approved:

MET-REPAIR presepsin (sCD14-ST)- substudy