DSMB=Data and Safety Monitoring Board=数据与安全监察委员会，这货是独立委员会，不属于药监机构……顺...
Summary This appendix contains sections titled: Background Principles of Monitoring Data and Safety Practical and Implementation Issues: Oversight of Monitoring Institutes and Centers Responsibilities Performance of Data and Safety Monitoring Examples of Monitoring OperationsSteven Piantadosi...
"We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19," said NIAID Director Anthony S. Fauci, M.D. "ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional be...
A National Institutes of Health clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with coronavirus disease 2019 (COVID-19) has formally concluded that the drug provides no clinical benefit to hospitalized patients. Though found not to cause ha...
An independent data and safety monitoring board (DSMB) will review interim safety and efficacy data to ensure patient well-being and safety as well as study integrity. The ITAC trial is associated with the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnershi...
While SAB-185 previously met the initial pre-specified safety and efficacy criteria to continue to the next phase of the Phase 3 ACTIV-2 trial, the independent Data and Safety Monitoring Board (DSMB) recommended that the study be stopped for ...
As is customary in clinical trials, the NHLBI established an independent data and safety monitoring board (DSMB) to monitor trial progress and participant safety. At a regularly scheduled meeting on April 25, 2011, the study's DSMB concluded that high dose, extended-release niacin offered no ...
Additionally, Noursi explained that pharmacy professionals play critical roles in laboratory research and clinical trials, coordination of studies, identifying toxic responses, monitoring for AEs, and serving on data safety and monitoring committees and as principal investigators. “Many pha...
) and then—if successful—in large animals such as pigs and non-human primates. The resulting third-party data will be shared with the larger research community and with the public. A key value of the SCGE Consortium is transparency, which enables others to access its research output and ...
data from a pre-specified interim data analysis reviewed by the Data Safety Monitoring Board (DSMB) in September. Both the Phase 2 and Phase 3 ACTIV-2 trials are sponsored and conducted by the National Institute of Allergy and Inf...