Leader: Hospices Civil de Lyon – Fabien Subtil
WP5 will cover all statistical analysis within the trial. This comprises the following objectives:
- Review the protocol (methodological and statistical aspects) and the Case Report Form
- Provide randomization tables
- Design the Statistical Analysis Plan
- Provide data for annual safety reports and DSMB evaluation
- Perform two pre-planned interim analyses
- Perform the final statistical analyses of the primary and secondary outcomes
- Provide data for health economic assessment and gender analysis
- Participate to the writing of scientific publications
- Prepare trial data for sharing with scientific collaborations and for making data accessible according to the principles of open access to research data
This WP will assure that the methodology of clinical trial allows for answering the research questions and testing the efficacy and safety of the treatment tested in the trial. To this end, WP5 will review the protocol and the case report form to insure that the trial objectives will be adequately addressed. WP5 will provide the randomization tables ensuring proper randomization according to the stratification defined in the protocol. Furthermore, in this WP the final Statistical Analysis Plan will be designed and all statistical analysis of primary and secondary endpoints at the two interim analyses and at the final analysis will be performed. Data for evaluation in WP4 (Ethics, safety, and patient reported outcome measures) and in WP6 (Health economic assessment and gender analysis) will be provided. Finally, WP5 will prepare all trial data for sharing in scientific collaborations and for making all data available to the public and freely accessible following the principles of open access to research data.
The WP Leader has a long lasting experience in statistics of large clinical trials. As independent biostatistician Fabien Subtil will not play any other role in the clinical trial. Integration of randomization tables will be made in close collaboration with Universitätsklinikum Heidelberg and WP1 (Clinical trial). The Statistical Analysis Plan will be finalized in collaboration with the Coordinating Investigator at Universitätsklinikum Heidelberg, the Neurological Principal Investigator at Universitätsklinikum Hamburg-Eppendorf, and all National Coordinators in WP1 (Clinical Trial).