期刊
JOURNAL OF INFECTIOUS DISEASES
卷 224, 期 12, 页码 1995-2000出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiab263
关键词
SARS-CoV-2; COVID19; clinical trials; vaccines; data and safety monitoring
资金
- National Institute of Allergy and Infectious Diseases
The US Federal Government has funded multiple phase 3 trials of COVID-19 vaccines and established a single DSMB to oversee and coordinate these trials, ensuring safety and shared insights. Challenges include the scale and pace of the trials, safety events related to a large number of participants, many of whom have underlying health risks, and the politicized environment in which the trials are conducted.
To speed the development of vaccines against SARS-CoV-2, the United States Federal Government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: (1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; (2) safety, including individual events of concern and comparisons by randomized group; and (3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100 000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据