Work package 6

Safety Monitoring

Leader: Prof. Dr. Götz Thomalla
Universitätsklinikum Hamburg-Eppendorf

Main objectiveS

Monitoring of the safety of the patients in the PRECIOUS trial. As the overall aim of PRECIOUS is to improve the outcome of patients with acute stroke, the safety of patients is of highest priority throughout all stages of the project.

To ensure this, WP 6 will:

Assure that the PRECIOUS trial is performed according to ICH-GCP guidelines and to international, European and national legislation (Task 1, 2)

Assure the safety of patients enrolled in the clinical trial by monitoring all reported serious adverse events and reactions and by performing a continuous risk/benefit evaluation according to the national and European requirements (Task 2, 3, 4, 5)

Description of the tasks

The safety of patients enrolled will of highest priority in PRECIOUS. PRECIOUS will comply with applicable ethical guidelines and legislation. Moreover, the assessment of safety of the treatments studied is one of the main aims of PRECIOUS. WP 6 will constitute the necessary institutions and boards to supervise and monitor PRECIOUS 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 with regard to safety reporting.

The main tasks of WP 6 will be:

Development of a safety management plan.

Establish an independent Data and Safety Monitoring Board (DSMB) to assess safety, efficacy, and futility of the trial treatments on a regular basis; the DSMB will conduct interim analyses of safety after 600, 1200, 1800, 2400, and 3000 patients have completed follow-up.

Safety Desk: a Safety Desk has been established at CTC North together with UKE; the Safety Desk will be responsible for safety monitoring (pharmacovigilance) of the clinical trial in PRECIOUS; at the Safety Desk all SAE reports will be collected, documented, and coded according to MedDRA; SAEs and Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported to the relevant authorities; annual safety reports and a final safety report will be provided.

Establish an independent Ethics Advisory Board (EAB) involving a representative of the European stroke patient organisation SAFE, a medical ethicist, and a stroke and clinical trial expert trained in Geriatric Medicine; the EAB has reviewed the trial protocol.

PRECIOUS: List of Work Packages

WP 1: Trial Management

WP 2: Outcome Adjudication

WP 3: Infections and Antimicrobial Resistance

WP 4: Monitoring

WP 5: Health Economics

WP 6: Safety Monitoring

WP 7: Statistical Analysis

WP 8: Dissemination, Exploitation and Communication

WP 9: Project Management