Comparar métodos
Examine os métodos selecionados lado a lado; as linhas que diferem ficam destacadas.
| Ensaio Clínico Multicêntrico de Fase II× | Ensaio Clínico Adaptativo de Fase II× | |
|---|---|---|
| Área | Epidemiologia | Epidemiologia |
| Família | Process / pipeline | Process / pipeline |
| Ano de origem≠ | 1970s–1980s (formalized in regulatory guidance; Simon two-stage design 1989) | 1994 (formal framework); widespread adoption 2000s–2010s |
| Autor original≠ | Established through ICH and FDA regulatory frameworks; Simon two-stage design formalized by Richard Simon (1989) | Peter Bauer & Klaus Kohne (formal statistical framework, 1994); broader adaptive trial methodology developed through FDA and ICH guidance in the 2000s |
| Tipo≠ | Interventional clinical trial design | Experimental clinical trial design |
| Fonte seminal≠ | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2009). ICH Harmonised Tripartite Guideline: General Considerations for Clinical Studies E8(R1). ICH. link ↗ | Bauer, P., & Kohne, K. (1994). Evaluation of experiments with adaptive interim analyses. Biometrics, 50(4), 1029–1041. DOI ↗ |
| Outros nomes | multi-site phase II trial, phase 2 multicenter study, multicenter Phase IIA/IIB trial, multisite efficacy trial | Adaptive Ph II trial, seamless adaptive Phase II, adaptive dose-finding trial, response-adaptive Phase II |
| Relacionados≠ | 6 | 1 |
| Resumo≠ | A multicenter phase II clinical trial is an interventional study conducted at two or more independent clinical sites to evaluate the preliminary efficacy and safety of a new treatment in a defined patient population, following demonstrated tolerability in phase I. By pooling patients across sites, the design achieves the sample sizes needed to estimate response rates and identify promising signals before committing to the larger investment of a phase III confirmatory trial. | An adaptive Phase II clinical trial is a prospective experimental design in which pre-specified rules allow the study protocol to be modified — such as dropping arms, adjusting sample size, or narrowing the patient population — based on accumulating interim data, without inflating the Type I error rate. The design is widely used in early-phase drug development to screen candidate doses or treatments efficiently while preserving statistical validity. |
| ScholarGateConjunto de dados ↗ |
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