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| Studio Clinico Retrospettivo di Fase II× | Sperimentazione Clinica di Fase II× | |
|---|---|---|
| Campo | Epidemiologia | Epidemiologia |
| Famiglia | Process / pipeline | Process / pipeline |
| Anno di origine≠ | 1980s–1990s (with growth in oncology retrospective analyses) | 1960s–1970s (formalised in US federal drug regulation) |
| Ideatore≠ | Adapted from standard Phase II trial methodology; retrospective variant formalized in oncology practice | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) |
| Tipo≠ | Observational retrospective study | Interventional clinical study design |
| Fonte seminale≠ | Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials, 10(1), 1–10. 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: 978-3319185392 |
| Alias | retrospective Phase II study, historical Phase II analysis, retrospective efficacy study, Phase II retrospective analysis | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial |
| Correlati≠ | 5 | 6 |
| Sintesi≠ | A retrospective Phase II clinical trial evaluates a treatment's preliminary efficacy and safety signals using existing archival data — medical records, registries, or electronic health records — rather than prospectively enrolling new patients. It mirrors the objectives of a standard Phase II trial (estimating response rate, tolerability, and early efficacy) but does so by looking backward at patients who have already received the intervention, making it faster and less costly than a prospective design. | A Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment. |
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