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| Meta-analytische Phase-III-Klinische Studie× | Randomisierte kontrollierte Studie (RCT)× | |
|---|---|---|
| Fachgebiet≠ | Epidemiologie | Versuchsplanung |
| Familie≠ | Process / pipeline | Hypothesis test |
| Entstehungsjahr≠ | 1976 (meta-analysis); systematic application to Phase III RCTs from 1990s onward | 1948 |
| Urheber≠ | Glass, G. V. (meta-analysis formalized); applied to Phase III trials via Cochrane Collaboration (Chalmers, Altman, Higgins) | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Typ≠ | Systematic quantitative evidence synthesis | Interventional comparative study |
| Wegweisende Quelle≠ | Whitehead, A. (2002). Meta-Analysis of Controlled Clinical Trials. Wiley. ISBN: 978-0471983705 | Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗ |
| Aliasnamen | Phase III meta-analysis, pooled Phase III analysis, systematic review of Phase III RCTs, confirmatory meta-analysis | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Verwandt≠ | 3 | 7 |
| Zusammenfassung≠ | A meta-analytic Phase III clinical trial is a systematic, quantitative synthesis of multiple Phase III randomized controlled trials (RCTs) examining the same intervention. By pooling confirmatory trial data under a pre-registered protocol, the approach yields more precise effect estimates, resolves conflicting findings across trials, and supports regulatory or clinical guideline decisions with the highest level of evidence available in the evidence hierarchy. | A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010). |
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