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| دراسة المرحلة الرابعة الاستقصائية× | دراسة المرحلة الرابعة× | |
|---|---|---|
| المجال | علم الأوبئة | علم الأوبئة |
| العائلة | Process / pipeline | Process / pipeline |
| سنة النشأة≠ | 1970s–1980s (formalized in post-marketing regulatory frameworks) | Formalised 1970s–1990s (ICH E3 guideline 1994) |
| صاحب الطريقة≠ | Regulatory and pharmaceutical research community (ICH E2E, EMA PASS guidelines) | Regulatory agencies and pharmaceutical industry (ICH, FDA, EMA frameworks) |
| النوع≠ | Observational / interventional post-marketing study design | Post-marketing observational or interventional study |
| المصدر التأسيسي≠ | Strom, B.L. (Ed.). (2005). Pharmacoepidemiology (4th ed.). Wiley. ISBN: 978-0470863088 | International Conference on Harmonisation (ICH). (1994). ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. ICH Secretariat. link ↗ |
| الأسماء البديلة | prospective post-marketing surveillance study, prospective pharmacovigilance study, prospective post-authorization safety study, PASS (prospective) | post-marketing surveillance study, post-approval study, Phase 4 study, PMS study |
| ذات صلة | 5 | 5 |
| الملخص≠ | 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. | 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. |
| ScholarGateمجموعة البيانات ↗ |
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