Optimal planning of adaptive two-stage designs.
Stat Med
; 40(13): 3196-3213, 2021 06 15.
Article
em En
| MEDLINE
| ID: mdl-33738842
ABSTRACT
Adaptive designs are playing an increasingly important role in the planning of clinical trials. While there exists various research on the optimal determination of a two-stage design, non-optimal versions still are frequently applied in clinical research. In this article, we strive to motivate the application of optimal adaptive designs and give guidance on how to determine them. It is demonstrated that optimizing a trial design with respect to particular objective criteria can have a substantial benefit over the application of conventional adaptive sample size recalculation rules. Furthermore, we show that in many practical situations, optimal group-sequential designs show an almost negligible performance loss compared to optimal adaptive designs. Finally, we illustrate how optimal designs can be tailored to specific operational requirements by customizing the underlying optimization problem.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
Tipo de estudo:
Guideline
Idioma:
En
Revista:
Stat Med
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Alemanha