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| Metaanaliza badań klinicznych II fazy× | Randomizowane badanie kontrolowane (RCT)× | |
|---|---|---|
| Dziedzina≠ | Epidemiologia | Planowanie eksperymentów |
| Rodzina≠ | Process / pipeline | Hypothesis test |
| Rok powstania≠ | 2000s–2010s | 1948 |
| Twórca≠ | Developed within clinical epidemiology and oncology statistics; key contributions by Sutton, Warmuth, and colleagues | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Typ≠ | Hybrid clinical trial / meta-analytic design | Interventional comparative study |
| Źródło pierwotne≠ | Warmuth, M., & Hinzmann, B. (2013). Phase II trials in oncology: From the statistical design of trials to the meta-analysis of the results. Onkologie, 36(9), 555–564. link ↗ | 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 ↗ |
| Inne nazwy | MA-Phase II, meta-analytic single-arm trial, pooled Phase II design, Phase II meta-analysis | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Pokrewne≠ | 2 | 7 |
| Podsumowanie≠ | A meta-analytic Phase II clinical trial integrates individual or aggregate data from multiple single-arm or small Phase II studies into a unified meta-analytic framework. Rather than relying on a single underpowered trial to screen for activity, this design pools evidence across comparable cohorts to obtain a more reliable estimate of treatment response, enabling better-informed go/no-go decisions before committing to a large Phase III randomized trial. | 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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