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| Адаптирано проучване Фаза IV× | Проучване Фаза IV× | |
|---|---|---|
| Област | Епидемиология | Епидемиология |
| Семейство | Process / pipeline | Process / pipeline |
| Година на възникване≠ | 1990s–2000s (regulatory formalization of adaptive Phase IV designs) | Formalised 1970s–1990s (ICH E3 guideline 1994) |
| Създател≠ | Adaptive design principles developed by multiple statisticians; Phase IV framework established by regulatory bodies (FDA, EMA) in the late 20th century | Regulatory agencies and pharmaceutical industry (ICH, FDA, EMA frameworks) |
| Тип≠ | Adaptive post-marketing clinical study design | Post-marketing observational or interventional study |
| Основополагащ източник≠ | Chow, S. C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman and Hall/CRC. ISBN: 978-1584889625 | International Conference on Harmonisation (ICH). (1994). ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. ICH Secretariat. link ↗ |
| Други названия | adaptive post-marketing surveillance study, adaptive pharmacovigilance study, adaptive Phase IV trial, adaptive post-approval study | post-marketing surveillance study, post-approval study, Phase 4 study, PMS study |
| Свързани≠ | 6 | 5 |
| Резюме≠ | An Adaptive Phase IV study is a post-marketing surveillance study conducted after a drug or intervention has received regulatory approval, augmented with pre-specified adaptive design elements that allow pre-planned modifications to the study protocol in response to accumulating data. These modifications may include sample size re-estimation, endpoint adjustments, or population enrichment, all governed by statistical rules set before the study begins, preserving scientific integrity while increasing efficiency. | A Phase IV study is a post-marketing surveillance study conducted after a drug, device, or intervention has received regulatory approval. Its primary purpose is to monitor long-term safety, detect rare adverse events, assess effectiveness in routine clinical practice, and explore new indications or populations not adequately represented in earlier trials. Phase IV evidence accumulates continuously throughout a product's commercial life. |
| ScholarGateНабор от данни ↗ |
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