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Barnes Maze Testing Strategies with Small and Large Rodent Models

Barnes Maze Testing Strategies with Small and Large Rodent Models

Published on: February 26, 2014

Dynamic borrowing methods for basket trials with order restrictions.

Lauren Kanapka¹, Anastasia Ivanova¹

¹Department of Biostatistics, The University of North Carolina, Chapel Hill, NC, USA.

Journal of Biopharmaceutical Statistics

|April 2, 2026

Summary

This summary is machine-generated.

Order-restricted methods for basket trials can reduce sample sizes by 10% when response order assumptions hold. However, these methods risk inflated type 1 error rates and reduced power if assumptions are violated.

Keywords:

Basket trials Bayesian model averaging adaptive lasso dynamic borrowing order restricted inference

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Area of Science:

Biostatistics
Clinical Trial Design
Pharmacology

Background:

Basket trials evaluate new therapies across multiple patient subgroups (baskets) under a single protocol.
Subgroups can be defined by disease type, biomarkers, or patient characteristics.
Prior knowledge of response order between baskets can inform trial design.

Purpose of the Study:

To modify existing dynamic borrowing methods for single-arm basket trials with binary endpoints.
To incorporate known response order information between baskets.
To assess the impact of order-restricted methods on sample size and statistical performance.

Main Methods:

Modification of two previously published dynamic borrowing methods.
Incorporation of known response order assumptions between baskets.
Evaluation of statistical properties including sample size, type 1 error rate, and power.

Main Results:

Order-restricted methods require marginally smaller sample sizes (approx. 10% reduction for a five-basket trial) when order assumptions are met.
When order assumptions hold and the study is adequately powered, these methods are efficient.
Violations of order assumptions lead to inflated type 1 error rates and reduced power.

Conclusions:

Incorporating known response orders into dynamic borrowing methods can improve sample size efficiency in basket trials.
Careful consideration of order assumptions is crucial, as violations can negatively impact trial validity.
These modified methods offer a potential advantage when prior biological or clinical information supports response order.