Substudies in the TTM2-trial will be pre-defined analyses with separate protocols from the main study. As TTM2 is likely to be the largest trial to date on cardiac arrest there are numerous opportunities for additional research.
A sub-study can either be multi-centre or local (single-centre). Multi-centre studies should be submitted before the start of the trial and the publication of a trial protocol is highly encouraged. Single-centre trials should be submitted before local recruitment begins. A few things should be considered when planning a study.
1. That the study does not bias the results of the main trial.
2. Ethical approval. (If necessary)
3. That the study is approved by the steering group.
4. Funding for any additional costs needs to be secured.
To move forward with an idea for a substudy we suggest that sites collaborate and submit joint proposals. A short description of the study, using this form
, should then be sent by April 30 to firstname.lastname@example.org
We will try to connect sites with each other if similar proposals are received. Proposals might also be published on the website in order to recruit other sites. The final decision on sub-study approval will be taken at a steering group meeting and a full study protocol should be available before the start of the trial so that it can be published on the TTM2-website.