WP06 - Data management, statistics

This WP will ensure proper management of all data acquired in the clinical trial and perform statistical analysis allowing for answering the research questions and testing the hypothesis of the clinical trial. The objectives of WP06 are:

  • Assure that the methodology of clinical trial allows for answering the research questions and testing the efficacy and safety of MRI-based thrombolysis in wake-up stroke patients;
  • Management and statistical analysis of all clinical data;
  • Set ground for safety reports and final judgement and report on the efficacy of MRI-based thrombolysis in wake-up stroke patients in the clinical trial;
  • Enable data pooling and sharing with other clinical trials and collaborative stroke archives;
  • Foster further insights into relevant aspects of stroke impact on society (gender aspects, cost-effectiveness of MRI based thrombolysis in wake-up stroke). 

Proper data management and statistical analysis is a prerequisite for the successful and safe conduction of the clinical trial. This WP will ensure that appropriate methodology is used in planning and conducting of the clinical trial.

The WP will be lead by participant 06 (P. Roy, Service de Biostatistique, HCL), who has a long lasting experience in statistics of large clinical trials. As independent biostatistician P. Roy will not play any other role in the clinical trial. The development of the database will be lead by participant 01 (UKE, CTC North), which will be responsible for overall trial management (see WP03). The estimation of cost-effectiveness of MRI-based thrombolysis in wake-up stroke will be performed together with participant 07 (UG) and WP09. The WP will be active during month 01-60.

Participants involved in WP01: