Following regulatory guidelines, the participant's illness is being reviewed and monitored by an independent Data Safety Monitoring Board (DSMB) and the company's own internal clinical and safety physicians. The study pause is a standard component of the clinical trial protocol, and is different from a regulatory hold, according to the company.
The phase III Ensemble trial was initiated in September and aims to enroll over 60,000 individuals globally. With a study of this magnitude, the company noted that adverse events are an anticipated occurrence. The pause will allow it to review all relevant medical information to determine whether to restart the study.
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