Run time of 1000 iterations in a pilot study.

<div><p>Basket trial designs are a type of master protocol in which the same therapy is tested in several strata of the patient cohort. Many basket trial designs implement borrowing mechanisms. These allow sharing information between similar strata with the goal of increasing power in re...

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محفوظ في:
التفاصيل البيبلوغرافية
المؤلف الرئيسي: Lukas D. Sauer (19588975) (author)
مؤلفون آخرون: Alexander Ritz (15248653) (author), Meinhard Kieser (19173) (author)
منشور في: 2025
الموضوعات:
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الملخص:<div><p>Basket trial designs are a type of master protocol in which the same therapy is tested in several strata of the patient cohort. Many basket trial designs implement borrowing mechanisms. These allow sharing information between similar strata with the goal of increasing power in responsive strata while at the same time constraining type-I error inflation to a bearable threshold. These borrowing mechanisms can be tuned using numerical tuning parameters. The optimal choice of these tuning parameters is subject to research. In a comparison study using simulations and numerical calculations, we are planning to investigate the use of utility functions for quantifying the compromise between power and type-I error inflation and the use of numerical optimization algorithms for optimizing these functions. The present document is the protocol of this comparison study, defining each step of the study in accordance with the ADEMP scheme for pre-specification of simulation studies.</p></div>