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| Prospektive Phase-IV-Studie× | Randomisierte klinische Studie (RCT)× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1970s–1980s (formalized in post-marketing regulatory frameworks) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Urheber≠ | Regulatory and pharmaceutical research community (ICH E2E, EMA PASS guidelines) | Austin Bradford Hill; MRC Streptomycin Trial team |
| Typ≠ | Observational / interventional post-marketing study design | Interventional experimental study |
| Wegweisende Quelle≠ | Strom, B.L. (Ed.). (2005). Pharmacoepidemiology (4th ed.). Wiley. ISBN: 978-0470863088 | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 |
| Aliasnamen | prospective post-marketing surveillance study, prospective pharmacovigilance study, prospective post-authorization safety study, PASS (prospective) | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Verwandt≠ | 5 | 6 |
| Zusammenfassung≠ | 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 randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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