Comparar métodos
Examine os métodos selecionados lado a lado; as linhas que diferem ficam destacadas.
| Ensaio Clínico Randomizado Multicêntrico× | Estudo de Confirmação Fundamental (Fase III)× | |
|---|---|---|
| Área | Epidemiologia | Epidemiologia |
| Família | Process / pipeline | Process / pipeline |
| Ano de origem≠ | 1970s–1980s (widespread adoption for large-scale efficacy trials) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Autor original≠ | Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980s | FDA regulatory framework / ICH guidelines |
| Tipo≠ | Interventional experimental design | Confirmatory randomised controlled trial |
| Fonte seminal | 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 | 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 |
| Outros nomes | multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Relacionados | 6 | 6 |
| Resumo≠ | A multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments. | 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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