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| Klinische Prüfung der Phase III× | Multizentrische randomisierte klinische Studie× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1962 (Kefauver-Harris Amendment formalised phased drug development) | 1970s–1980s (widespread adoption for large-scale efficacy trials) |
| Urheber≠ | FDA regulatory framework / ICH guidelines | Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980s |
| Typ≠ | Confirmatory randomised controlled trial | Interventional experimental design |
| Wegweisende Quelle | 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 | 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 | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT | multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial |
| Verwandt | 6 | 6 |
| Zusammenfassung≠ | A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption. | A multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments. |
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