DSMB – DATA AND SAFETY MONITORING BOARD
In order to obtain an independent opinion with regard to the Study conducted in a group of patients suffer from rheumatoid arthritis, MABION SA erected the DSMB Committee - Data and Safety Monitoring Board. DSMB reviews, analyses and evaluates on a regular basis all attained data, including data concerning safety and efficacy of therapy as well as data credibility and Study progress. Performance of overall Study operations, adherence to the protocol, Study procedures and GCP by the Principal Investigator and Study Team members are also under DSMB surveillance. The DSMB Committee consists of group of experts in the field of rheumatology, clinical pharmacology and biostatistics. , The DSMB is obliged to serve an external and independent supervision of the participants safety. In case of occurrence of any unacceptable risk for trial subjects, treatment inefficacy or deviations from the safety profile of reference drug, DSMB is allowed to recommend modification of Study protocol, withhold the patients recruitment or even terminate the Study at any time based on the evaluation of safety results. The DSMB convenes at regular intervals. Until now MABION SA assembled five DSMB meetings, which resulted in receiving the positive expert’s opinion.