FDAAA TrialsTracker
收藏资源简介:
FDAAA TrialsTracker是一个跟踪临床试验结果报告合规性的数据库。该数据库根据2007年《食品药品管理局修正案》(FDAAA)的要求,监测和记录临床试验结果报告情况。数据显示,在30,767项试验中,有24,231项(78.8%)已报告结果,美国政府本可征收至少120亿美元的罚款,但实际罚款为0美元。该平台提供按状态、赞助商等筛选试验的功能,并记录逾期报告情况。
FDAAA TrialsTracker is a database designed to track the compliance of clinical trial result reporting. It monitors and documents the status of clinical trial result reporting in strict accordance with the mandates of the 2007 Food and Drug Administration Amendments Act (FDAAA). According to the dataset, out of 30,767 total trials, 24,231 (78.8%) have submitted their results; the U.S. government could have imposed fines totaling at least 12 billion USD for non-compliance, but the actual collected fines amounted to 0 USD. This platform provides functionalities to filter trials based on criteria such as trial status, sponsor, and other attributes, and also records instances of overdue result reporting.



