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| Adaptive Phase-III-Klinische Studie – Adaptives konfirmatorisches Studiendesign× | Klinische Prüfung der Phase III× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1969–2019 (sequential testing roots ~1969; formal adaptive design guidance 2010–2019) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Urheber≠ | Methodological foundations by Armitage et al. (1969); modern adaptive framework codified by FDA and ICH guidance (2010s) | FDA regulatory framework / ICH guidelines |
| Typ≠ | Interventional confirmatory clinical trial with pre-specified interim adaptations | Confirmatory randomised controlled trial |
| Wegweisende Quelle≠ | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2019). ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials. ICH Harmonised Guideline. 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 | adaptive confirmatory trial, seamless Phase II/III adaptive trial, adaptive pivotal trial, adaptive design Phase III | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Verwandt | 6 | 6 |
| Zusammenfassung≠ | An adaptive Phase III clinical trial is a confirmatory randomized controlled trial that incorporates pre-specified rules allowing modifications to the trial design — such as sample size re-estimation, dose selection, or population enrichment — based on accumulating interim data, while preserving the Type I error rate. It sits at the top of the evidence hierarchy and is used to obtain regulatory approval of new interventions. | 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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