Composition of the data monitoring committee, its role, and reporting structure {21a}
COMPLICATIONS
A Data Safety Monitoring Board (DSMB) has been created for this study. The DSMB is an advisory committee responsible for helping the sponsor to proactively monitor and gauge patient safety and risk in the clinical trial. To this end, the DSMB reviews the data and any issues that may occur during the trial, in particular scientific, ethical and tolerance issues, which may modify the benefit/risk ratio. Following this review, the DSMB shall provide its recommendations in writing to the sponsor. These recommendations may concern in particular the continuation, modification, or termination of the study. The sponsor remains the decision maker of the measures to be implemented, following the recommendations of the DSMB. The modalities of the organization of this DSMB are described in a charter signed by the members of the DSMB at the beginning of the research. The DSMB includes at least two clinical experts and a methodologist/biostatistician.Interim analysis will take place strictly for safety and ethical purposes. As soon as 20 patients per randomized group will be reached, data will be analyzed by the independent Data Safety Committee. The trial will be stopped if major complications (Grade ≥ III) are statistically significantly higher (