Substudy Proposals

If you want to submit a study proposal please use the proposal form available in the documents section.  All proposals will be assessed by the steering group and approved if the project is scientifically valid and does not bias the main trial. Funding and ethical approval should also be available if needed. Proposed substudies are described below. Click on the pdf for more information. 

Substudies: 
Substudies that require additional data have already been submitted and they have been approved centrally by the IRB in Sweden. Single centere substudies are still possible to submit for consideration by the steering group. IRB approval should be sought locally by the responsible site. 

Post-Hoc analysis:
Studies based primarily on data already available in the study database. A detailed analysis plan is preferable, but not necessary. Post-hoc analyses may be submitted until 1400 patients have been recruited. 

Biobank:
Suggestions for studies based on the TTM2-Biobank may be submitted, but the steering group will not process these suggestions until the trial is almost complete.