WP04 - Data and safety monitoring, ethics

The overall aim of WAKE-UP is to improve the treatment of patients with acute ischemic stroke. Thus, the safety of patients is of highest priority throughout all stages of the project. Symptomatic intracranial haemorrhage (SICH) is the most feared complication of thrombolysis in acute stroke and, together with mortality, will be the primary safety endpoint of the WAKE-UP clinical trial.

To guarantee these goals, this WP04 will:

  • Assure that the clinical trial in WAKE-UP trial is performed according to ICH-GCP guidelines and to international, European and national legislation;
  • Assure the safety of patients enrolled in the clinical trial.

This WP will constitute the necessary institutions and boards to supervise and monitor WAKE-UP, including: (1) an independent Ethics Advisory Board (EAB) composed of experienced stroke researchers with explicit experience in clinical trials: M. Hommel (CHU Grenoble, FRA), K. Lees (University of Glasgow, UK), K. Wegscheider (UKE, GER); (2) a Data and Safety Monitoring Board (DSMB) involving members from other participants (together with WP01). The chair of the DSMB will not be involved in the conduct of the clinical trial. These institutions will supervise the clinical trial protocol and conduction and continuously monitor safety of the clinical trial. Regular safety reports will be provided.

The WP will be headed by participant 06 (N. Nighoghossian, HCL), who has an extensive expertise in acute stroke clinical trials, which will also be responsible for data management and statistics (WP06, WP lead: P. Roy). As further partners the trial coordinator (UKE) will be involved, same as participant 07 (K. Muir, UG) with experience from current and previous memberships in steering committees of numerous clinical trials. The participation of participant 08 (SAFE) will ensure that the trial will comply with patients needs and stakeholders interests. The WP will be active during month 01-60.

Participants involved in WP04: