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| Multizentrische Phase-II-Klinische Studie× | Klinische Prüfung der Phase III× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1970s–1980s (formalized in regulatory guidance; Simon two-stage design 1989) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Urheber≠ | Established through ICH and FDA regulatory frameworks; Simon two-stage design formalized by Richard Simon (1989) | FDA regulatory framework / ICH guidelines |
| Typ≠ | Interventional clinical trial design | Confirmatory randomised controlled trial |
| Wegweisende Quelle≠ | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2009). ICH Harmonised Tripartite Guideline: General Considerations for Clinical Studies E8(R1). ICH. link ↗ | 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 | multi-site phase II trial, phase 2 multicenter study, multicenter Phase IIA/IIB trial, multisite efficacy trial | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Verwandt | 6 | 6 |
| Zusammenfassung≠ | A multicenter phase II clinical trial is an interventional study conducted at two or more independent clinical sites to evaluate the preliminary efficacy and safety of a new treatment in a defined patient population, following demonstrated tolerability in phase I. By pooling patients across sites, the design achieves the sample sizes needed to estimate response rates and identify promising signals before committing to the larger investment of a phase III confirmatory trial. | 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. |
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