Leader: Aarhus University Hospital – Claus Z. Simonsen

WP4 comprises supervision of ethics, safety, and patient relevant outcome measurement. The main objectives are:

• Ensure compliance of the trial with highest ethical standards, ICH-GCP guidelines and international, European and national legislation
• Ensure the safety of patients randomized in TENSION
• Guide the measurement of patient relevant outcomes in standardized patient reported outcome measures

The safety and well-being of patients enrolled will be the main priority of TENSION. To this end, TENSION will comply with applicable ethical guidelines and legislation. In addition, the proof of safety of thrombectomy in stroke patients with extended stroke lesions in an extended time window is one of the primary aims of TENSION. WP4 will constitute the necessary institutions and boards to supervise and monitor TENSION in general and the clinical trial in particular, assuring the safety of patients at each step, and ensuring that the project conforms to ethical and legislative guidelines and regulations.

This will involve establishing an Ethics Advisory Board (EAB), an independent Data and Safety Monitoring Board (DSMB), and a Scientific Advisory Board (SAB). These institutions will review the clinical trial protocol and continuously monitor safety of the clinical trial. Regular safety reports will be provided together with WP1 (Trial management) and WP5 (Statistics).

It is a key objective of TENSION to improve outcome and quality of life of patients. Thus, the trial will put the patients’ view into the centre of outcome evaluation using patient reported outcome measures (PROM), which represents an innovative and novel approach in stroke trials providing the basis for patient centred value-based healthcare assessment in stroke treatment. Special aspects of informed consent in acute stroke will be taken into account based on the workflow established in previous trials coordinated by members of the (THRILL, WAKE-UP) (Bendszus et al., 2015; Thomalla et al., 2014).

The WP Leader has an extensive expertise in acute stroke clinical trials. He will be supported by Universitätsklinikum Heidelberg, where the Safety Desk is located. SAFE, ICHOM, and Universitätsklinikum Hamburg-Eppendorf will support in integrating the patients perspective into the trial implementing the ICHOM Standard Set of Patient-Centered Outcome Measures After Stroke (Salinas et al., 2016) in the trial.