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| Studio clinico randomizzato di Fase II con abbinamento× | Trial Clinico Randomizzato (RCT)× | |
|---|---|---|
| Campo | Epidemiologia | Epidemiologia |
| Famiglia | Process / pipeline | Process / pipeline |
| Anno di origine≠ | 1960s–1980s (formalized with Simon optimal designs, 1989) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Ideatore≠ | Gehan (1961) for Phase II designs; matching frameworks adapted from case-control methodology | Austin Bradford Hill; MRC Streptomycin Trial team |
| Tipo≠ | Controlled clinical trial design | Interventional experimental study |
| Fonte seminale≠ | Gehan, E. A. (1961). The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases, 13(4), 346–353. DOI ↗ | 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 |
| Alias | matched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trial | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Correlati≠ | 5 | 6 |
| Sintesi≠ | A matched Phase II clinical trial is a single-arm or small-controlled early-efficacy study in which treated patients are paired with matched controls — drawn from historical databases, registries, or concurrent external cohorts — on key prognostic variables such as age, disease stage, and performance status. This design allows preliminary efficacy assessment without a concurrent randomized arm, trading randomization for feasibility while partially controlling for confounding through the matching process. | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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