Johnson and Johnson insisted that so-called adverse events – illness, accident, and other poor medical outcomes – are an expected part of clinical practice, and also emphasized the difference between study break and clinical hold, which is a formal formal regulatory action that lasts longer. Can survive. Vaccine studies are not currently under clinical hold. J&J said that when it comes to contacting clinical holders for the general public, it does not usually inform the public about the study pause.
The Data and Security Monitoring Board, or DSMB, called late Monday night to review the case. J&J said that in such cases ‘it is not always clear’ whether the participant who has experienced an adverse event received a study treatment or a placebo.
However, clinical trial suspensions are not uncommon – and in some cases last only a few days – they are generating outside attention in the race to test the vaccine against SARIZ-COVI-2, the virus that causes COVID-19.
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