方法证据记录
Prospective Phase IV Study
A prospective Phase IV study is a post-marketing investigation conducted after a drug, device, or intervention has received regulatory approval, following participants forward in real time to collect safety, effectiveness, and utilization data under routine clinical practice conditions. Unlike retrospective designs that mine existing records, prospective enrollment allows pre-specified data collection, defined follow-up windows, and direct measurement of outcomes as they occur, making it central to post-authorization safety surveillance and long-term effectiveness research.
源记录
引文逐字复制自方法源记录。这些引文不代表任何层级的验证。
Prospective Phase IV Post-Marketing Study
分类方法记录 · process-pipeline / epidemiology
- Strom, B.L. (Ed.). (2005). Pharmacoepidemiology (4th ed.). Wiley. · ISBN 978-0470863088
- Phase IV clinical trial. Wikipedia. · URL
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